Mantapath Consulting

Biologics License Applications (BLAs) for CBER-Regulated Products

The Biologics License Application is used to request permission to introduce, or deliver a biologic product into interstate commerce.

Published: Jul 17, 2026 | Category: FDA | Name: FDA Biologics

BIVIGAM

Product approval information is indicated for treatment of Primary Humoral Immunodeficiency

Published: Jul 17, 2026 | Category: FDA | Name: FDA Biologics

OCTAGAM

Product approval information is indicated for the treatment of chronicimmune purpura (ITP) in adults

Published: Jul 17, 2026 | Category: FDA | Name: FDA Biologics

FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol

The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, in adults with hypercholesterolemi

Published: Jul 17, 2026 | Category: FDA | Name: FDA Press Release

PANZYGA

Indicated for 1.) Primary humoral immunodeficiency (PI) in patients 2 years of age and older 2.) Chronic immune thrombocytopenic purpura (ITP) in adults

Published: Jul 17, 2026 | Category: FDA | Name: FDA Biologics

Cellular, Tissue, and Gene Therapies Advisory Committee July 30, 2026 Meeting Announcement- UPDATED INFORMATION (as of 7/16/2026) - 07/30/2026

This is the main page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) July 30, 2026 announcement and meeting materials.

Published: Jul 17, 2026 | Category: FDA | Name: FDA Biologics

Cellular, Tissue, and Gene Therapies Advisory Committee July 29, 2026 Meeting Announcement- UPDATED INFORMATION (as of 7/16/2026) - 07/29/2026

This is the main page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) July 29, 2026 announcement and meeting materials.

Published: Jul 17, 2026 | Category: FDA | Name: FDA Biologics

Drug Trials Snapshots: ZYCUBO

Drug Trials Snapshots: ZYCUBO

Published: Jul 17, 2026 | Category: FDA | Name: FDA Drugs

Gammaplex 5% & 10%

Gammaplex 5%: For the treatment of (1) primary humoral immunodeficiency (PI) in adults and pediatric patients two years of age and older; (2) chronic immune thrombocytopenic purpura (ITP)

Published: Jul 17, 2026 | Category: FDA | Name: FDA Biologics

Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Ebola Disease and HCT/P Donation

We are issuing this communication to provide information regarding Ebola disease and considerations for donor eligibility determinations for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Published: Jul 16, 2026 | Category: FDA | Name: FDA Biologics

MantroForce - 729021 - 06/17/2026

Unapproved New Drugs/Misbranded

Published: Jul 16, 2026 | Category: FDA | Name: FDA Drugs

Texinkart Inc. - 729046 - 06/17/2026

Unapproved New Drugs/Misbranded

Published: Jul 16, 2026 | Category: FDA | Name: FDA Drugs

Leading Edge Health Inc. - 729193 - 06/17/2026

Unapproved New Drugs/Misbranded

Published: Jul 16, 2026 | Category: FDA | Name: FDA Drugs

Wild Arabic Herbs - 729192 - 06/17/2026

Unapproved New Drugs/Misbranded

Published: Jul 16, 2026 | Category: FDA | Name: FDA Drugs

Hadassah Healing Oils Ltd - 729191 - 06/17/2026

Unapproved New Drugs

Published: Jul 16, 2026 | Category: FDA | Name: FDA Drugs

Indiangoods.shop - 729068 - 06/17/2026

Unapproved New Drugs/Misbranded

Published: Jul 16, 2026 | Category: FDA | Name: FDA Drugs

Great India Overseas Pvt. Ltd. dba Silkrute - 729065 - 06/17/2026

Unapproved New Drugs

Published: Jul 16, 2026 | Category: FDA | Name: FDA Drugs

Telos Trading Limited dba Alwinshop - 729062 - 06/17/2026

Unapproved New Drugs/Misbranded

Published: Jul 16, 2026 | Category: FDA | Name: FDA Drugs

JJLBRO - 729873 - 06/17/2026

Unapproved New Drugs/Misbranded

Published: Jul 16, 2026 | Category: FDA | Name: FDA Drugs

How to Spot Health Fraud

Published: Jul 16, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves First Oral Therapy that Inhibits Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) to Lower Bad Cholesterol in Adults with High Cholesterol

FDA has approved Lipfendra (enlicitide) as a treatment to be used with diet and exercise, to reduce low-density lipoprotein cholesterol (LDL-C) in adults with high cholesterol or who have an inherited type of high cholesterol called heterozygous familial hypercholesterolemia (HeFH).

Published: Jul 16, 2026 | Category: FDA | Name: FDA Drugs

Safe Drug Use After a Natural Disaster

Information on the use of medicines that may be affected by fire, flooding or unsafe water, and on the use of temperature-sensitive drugs when refrigeration is temporarily unavailable.

Published: Jul 15, 2026 | Category: FDA | Name: FDA Drugs

FDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses

The FDA today issued an Emergency Use Authorization (EUA) for Ivermectin Liquid for Horses (ivermectin oral solution) for the short-term prevention of New World screwworm (NWS) infestations (myiasis) in horses when administered within 24 hours of birth or at the time of initial wound care.

Published: Jul 15, 2026 | Category: FDA | Name: FDA Press Release

FDA/Duke-Margolis Institute for Health Policy Virtual Public Meeting: Innovation in Quantitative Medicine Summit - 09/01/2026

The Duke-Margolis Institute for Health Policy and the U.S. Food and Drug Administration's (FDA) Quantitative Medicine Center of Excellence (QM CoE) will co-convene a virtual workshop to inform the establishment of the Quantitative Medicine Innovation Network (QMIN).

Published: Jul 15, 2026 | Category: FDA | Name: FDA Drugs

An Enduring Mission in a New Era: The FDA Public Health Pillars

For 120 years the FDA's public health priorities have remained rooted in the same enduring mission. Today we are articulating our priorities in a way that reflects the scientific, technological and geopolitical reality shaping this new era of innovation as well as the future of public health.

Published: Jul 15, 2026 | Category: FDA | Name: FDA Drugs

FDA Roundtable: Strengthening the Supply Chain for Blood Manufacturing - September 29, 2026 - 09/29/2026

On September 29, 2026, the Food and Drug Administration’s, Center for Biologics Evaluation and Research, Office of Blood Research and Review is hosting a roundtable on strengthening the supply chain for the collection and manufacturing of Whole Blood and blood components for transfusion and further manufacturing, including Source Plasma.

Published: Jul 15, 2026 | Category: FDA | Name: FDA Biologics

FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates - 09/29/2026

Join SBIA as FDA shares the latest updates on registration and listing submissions, including current validation rules, and walks through the evolving regulatory requirements and compliance framework that shape how industry engages with these processes.

Published: Jul 15, 2026 | Category: FDA | Name: FDA Drugs

Xian Ling may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Xian Ling, a product promoted and sold for pain on various websites and in some retail stores.

Published: Jul 14, 2026 | Category: FDA | Name: FDA Drugs

Tawon Liar contains hidden drug ingredient

FDA is advising consumers not to purchase or use Tawon Liar, a product promoted and sold for pain, rheumatism, insomnia, improving the immune system, increasing energy, and lowering cholesterol on various websites, including www.etsy.com, and possibly in some retail stor

Published: Jul 14, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves First Generics of Gilotrif (afatinib) Tablets

The U.S. Food and Drug Administration approved the first generic versions of GILOTRIF (afatinib tablets) for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-a

Published: Jul 14, 2026 | Category: FDA | Name: FDA Drugs

FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer

On July 14, 2026, the Food and Drug Administration approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic bre

Published: Jul 14, 2026 | Category: FDA | Name: FDA Drugs

FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

Published: Jul 14, 2026 | Category: FDA | Name: FDA Drugs

Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

Published: Jul 14, 2026 | Category: FDA | Name: FDA Drugs

Spa De Soleil, Inc. - 728508 - 07/08/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 14, 2026 | Category: FDA | Name: FDA Drugs

International Medication Systems Limited - 727560 - 07/02/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 14, 2026 | Category: FDA | Name: FDA Drugs

FDA Roundup: April 12, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Jul 14, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus

The FDA approved Ixchiq, the first vaccine for prevention of disease caused by chikungunya virus in individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus.

Published: Jul 14, 2026 | Category: FDA | Name: FDA Biologics

FDA Approves First At-home Starting Dose for Alzheimer’s Disease Treatment

The U.S. Food and Drug Administration (FDA) has approved a new starting dosage regimen for the subcutaneous (under the skin) formulation of Leqembi (lecanemab-irmb), an amyloid beta-directed antibody indicated for the treatment of adult patients with Alzheimer's disease.

Published: Jul 13, 2026 | Category: FDA | Name: FDA Drugs

Psychedelic Drugs

FDA is supporting the development of psychedelic drugs, including new treatments for serious mental health conditions.

Published: Jul 13, 2026 | Category: FDA | Name: FDA Drugs

Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs

Published: Jul 13, 2026 | Category: FDA | Name: FDA Drugs

Psychedelic Drugs: Considerations for Clinical Investigations

Published: Jul 13, 2026 | Category: FDA | Name: FDA Drugs

Considerations for Potential Future Therapeutic Use of Psychedelic Drugs Public Hearing - 09/14/2026

The Food and Drug Administration is announcing a public hearing on the potential future therapeutic use of psychedelic drugs.

Published: Jul 13, 2026 | Category: FDA | Name: FDA Drugs

MOU 225-26-007

This Memorandum of Understanding ("MOU") between the U.S. Department of Health and Human Services (HHS), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Veterans Affairs (VA) (hereafter “the Parties” or “Federal Partners”) provides a framework for collaboration and the exchan

Published: Jul 13, 2026 | Category: FDA | Name: FDA Drugs

Topical Dermatologic Corticosteroids: In Vivo Bioequivalence

Topical Dermatologic Corticosteroids: In Vivo Bioequivalence

Published: Jul 13, 2026 | Category: FDA | Name: FDA Drugs

Data-Cyte Plus, Reverse-Cyte, Search-Cyte Reagent Red Blood Cells - STN 103898

Reagent Red Blood Cells Approval Page

Published: Jul 10, 2026 | Category: FDA | Name: FDA Biologics

FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer

On July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvan

Published: Jul 10, 2026 | Category: FDA | Name: FDA Drugs

FDA Proposes Rule to Modernize Drug Manufacturing Registration

The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a single establishment using a “hub-and-spoke” model.

Published: Jul 10, 2026 | Category: FDA | Name: FDA Press Release

FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications

Published: Jul 10, 2026 | Category: FDA | Name: FDA Drugs

FDA Actions to Support and Strengthen Domestic Drug Manufacturing

The FDA is taking decisive steps to strengthen U.S. pharmaceutical manufacturing, improve supply chain resilience, and ensure Americans have reliable access to safe, effective, high-quality medicines.

Published: Jul 9, 2026 | Category: FDA | Name: FDA Drugs

The FDA at 120: A Long, Distinguished History Protecting Americans

Since 1906 Americans have relied on, and benefited from, the FDA’s oversight of our food, medical products, veterinary products, cosmetics, and so much more.

Published: Jul 9, 2026 | Category: FDA | Name: FDA Drugs

Drug Repurposing: Considerations for Selection Criteria and Prioritization - 08/05/2026

On August 5, 2026, the Reagan-Udall Foundation for the FDA, will convene a hybrid public meeting to discuss opportunities to expand treatment options for patients by identifying new uses for FDA-approved drugs.

Published: Jul 9, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: VOYXACT

Published: Jul 8, 2026 | Category: FDA | Name: FDA Drugs

Geenius HIV 1/2 Supplemental Assay (BL 125670)

The Geenius HIV 1/2 Supplemental Assay is a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2) in serum, or plasma samples from blood donors.

Published: Jul 8, 2026 | Category: FDA | Name: FDA Biologics

Procleix Ultrio Plus Assays

Product approval information for: •Use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors. •Use in testing individual samples from living donors o

Published: Jul 8, 2026 | Category: FDA | Name: FDA Biologics

Procleix Ultrio Assay

Product approval information is intended for: • Use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors. • Use in testing individual samples from l

Published: Jul 8, 2026 | Category: FDA | Name: FDA Biologics

HPC, Cord Blood - MD Anderson Cord Blood Bank

Product approval information is indicated for use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are

Published: Jul 8, 2026 | Category: FDA | Name: FDA Biologics

HEPLISAV-B

Indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

Published: Jul 8, 2026 | Category: FDA | Name: FDA Biologics

Cellular, Tissue, and Gene Therapies Advisory Committee July 30, 2026 Meeting Announcement - 07/30/2026

This is the main page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) July 30, 2026 announcement and meeting materials.

Published: Jul 8, 2026 | Category: FDA | Name: FDA Biologics

Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations

Published: Jul 7, 2026 | Category: FDA | Name: FDA Drugs

Medical Products for Rare Diseases and Conditions

The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons

Published: Jul 7, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves New Treatment to Reduce Proteinuria in Adults with Primary Immunoglobulin A Nephropathy

The U.S. Food and Drug Administration (FDA) has approved Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression.

Published: Jul 7, 2026 | Category: FDA | Name: FDA Drugs

ketaminetroches.com - 725148 - 06/23/2026

Unapproved New Drugs/Misbranded

Published: Jul 7, 2026 | Category: FDA | Name: FDA Drugs

Buy Keta Online / www.buyketaonline.com - 725145 - 06/23/2026

Unapproved New Drugs/Misbranded

Published: Jul 7, 2026 | Category: FDA | Name: FDA Drugs

Ketamine Troche Store / www.ketaminetrochestore.com - 722122 - 06/23/2026

Unapproved New Drugs/Misbranded

Published: Jul 7, 2026 | Category: FDA | Name: FDA Drugs

Ketamine Store / www.ketaminestore.org - 725147 - 06/23/2026

Unapproved New Drugs/Misbranded

Published: Jul 7, 2026 | Category: FDA | Name: FDA Drugs

Legit Ketamine Suppliers / www.legitketaminesuppliers.com - 725149 - 06/23/2026

Unapproved New Drugs/Misbranded

Published: Jul 7, 2026 | Category: FDA | Name: FDA Drugs

Ketdaxandrugs / www.ketdaxandrugs.org - 725155 - 06/23/2026

Unapproved New Drugs/Misbranded

Published: Jul 7, 2026 | Category: FDA | Name: FDA Drugs

Med Shop Inc / www.medshopinc.com - 725157 - 06/23/2026

Unapproved New Drugs/Misbranded

Published: Jul 7, 2026 | Category: FDA | Name: FDA Drugs

All Ketamine HCL / www.allketaminehcl.com - 725150 - 06/23/2026

Unapproved New Drugs/Misbranded

Published: Jul 7, 2026 | Category: FDA | Name: FDA Drugs

Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com - 725151 - 06/23/2026

Unapproved New Drugs/Misbranded

Published: Jul 7, 2026 | Category: FDA | Name: FDA Drugs

Extra Medication / www.extramedication.com - 725152 - 06/23/2026

Unapproved New Drugs/Misbranded

Published: Jul 7, 2026 | Category: FDA | Name: FDA Drugs

Ketacyn Pharmaceuticals / www.ketacynpharma.com - 725153 - 06/23/2026

Unapproved New Drugs/Misbranded

Published: Jul 7, 2026 | Category: FDA | Name: FDA Drugs

Keta Med Lab / www.ketamedlab.com - 725154 - 06/23/2026

Unapproved New Drugs/Misbranded

Published: Jul 7, 2026 | Category: FDA | Name: FDA Drugs

Ket Plug / ketaminelab.org and buyketaminepowderonline.com - 728919 - 06/23/2026

Unapproved New Drugs/Misbranded

Published: Jul 7, 2026 | Category: FDA | Name: FDA Drugs

Biotestcell and Erytypecell

Product approval information is indicated for use in manual tube testing and Reagent Red Blood Cells For Use in Automated Systems are for use on the TANGO® optimo automated blood grouping and antibody test system.

Published: Jul 6, 2026 | Category: FDA | Name: FDA Biologics

DENGVAXIA

DENGVAXIA For the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. DENGVAXIA is approved for use in individuals 9 through 16 years of age with laboratoryconfirmed previous dengue infection and living in endemic areas.

Published: Jul 6, 2026 | Category: FDA | Name: FDA Biologics

Advate

Product approval information indicated for: ◦Control and prevention of bleeding episodes in adults and children (0-16 16 years) with Hemophilia A. ◦Perioperative management in adults and children (0-16 years) with 18 Hemophilia A. ◦Routine prophylaxis to prevent or reduce the frequency of bleeding 2

Published: Jul 6, 2026 | Category: FDA | Name: FDA Biologics

Innovation to Respond to COVID-19

Learn about FDA’s innovative approaches to respond to COVID-19 as quickly and safely as possible.

Published: Jul 6, 2026 | Category: FDA | Name: FDA Drugs

Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

Today, the FDA issued an emergency use authorization for the drug baricitinib, in combination with remdesivir, for the treatment of COVID-19 in hospitalized adults and pediatric patients 2+ years requiring supplemental oxygen, invasive mechanical ventilation, or ECMO.

Published: Jul 6, 2026 | Category: FDA | Name: FDA Drugs

COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs

FDA is committed to transparency around the EUA process

Published: Jul 6, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves First Treatment for COVID-19

FDA approved the antiviral drug Veklury (remdesivir) for adults and pediatric patients 12 years of age and older for the treatment of COVID-19 requiring hospitalization. Veklury is the first treatment for COVID-19 to receive FDA approval.

Published: Jul 6, 2026 | Category: FDA | Name: FDA Drugs

Coronavirus (COVID-19) Update: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use

FDA is warning about a potential drug interaction with remdesivir, which received emergency use authorization to treat hospitalized COVID-19 patients with severe disease.

Published: Jul 6, 2026 | Category: FDA | Name: FDA Drugs

Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment

FDA has issued emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.

Published: Jul 6, 2026 | Category: FDA | Name: FDA Drugs

FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—the science of safety and effectiveness

FDA recognizes that patients affected by coronavirus 2019 (COVID-19) are in great need of medicines to treat this disease. To help meet this need, the agency is helping to speed the development of promising therapies through its Coronavirus Treatment Acceleration Program (CTAP).

Published: Jul 6, 2026 | Category: FDA | Name: FDA Drugs

NUWIQ

Product approval information is indicated for adults and children with Hemophilia A for: • On-demand treatment and control of bleeding episodes • Perioperative management of bleeding • Routine prophylaxis to reduce the frequency of bleeding episodes

Published: Jul 6, 2026 | Category: FDA | Name: FDA Biologics

Ensuring the Safety of Patients in Clinical Trials Studying Investigational New Drugs to Prevent or Treat COVID-19

FDA has a critical role in ensuring the safety of patients in clinical trials studying drugs for the prevention or treatment of COVID-19 that require an investigational new drug (IND) application.

Published: Jul 6, 2026 | Category: FDA | Name: FDA Drugs

KOVALTRY

KOVALTRY®, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:  On-demand treatment and control of bleeding episodes  Perioperative

Published: Jul 6, 2026 | Category: FDA | Name: FDA Biologics

Alinity m HIV-1

The Alinity m HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantification of Human Immunodeficiency Virus type 1 (HIV-1) RNA on the automated Alinity m System in human plasma from HIV-1 infected individuals.

Published: Jul 6, 2026 | Category: FDA | Name: FDA Biologics

GLASSIA

Product approval information is indicated for treatment of chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha-1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin.

Published: Jul 6, 2026 | Category: FDA | Name: FDA Biologics

STRATAGRAFT

For the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns)

Published: Jul 6, 2026 | Category: FDA | Name: FDA Biologics

Creative Essences, Inc. - 710658 - 09/25/2025

Nonprescription/OTC

Published: Jul 6, 2026 | Category: FDA | Name: FDA Drugs

Dixon Investments Inc. dba ARI - 710087 - 09/17/2025

Nonprescription/OTC

Published: Jul 6, 2026 | Category: FDA | Name: FDA Drugs

LyfeUnit / www.lyfeunit.com - 725156 - 06/23/2026

Unapproved New Drugs/Misbranded

Published: Jul 5, 2026 | Category: FDA | Name: FDA Drugs

FDA Alerts Health Care Providers to Cases of Neurologic Complications from General Anesthesia Linked to Genetic Variant in Patients of Maternal Venezuelan Ancestry

The U.S. Food and Drug Administration (FDA) is investigating the safety of sevoflurane and other general anesthetics based on published scientific reports of unexpected catastrophic outcomes, including severe neurologic adverse outcomes and death, occurring in adult and pediatric patients.

Published: Jul 2, 2026 | Category: FDA | Name: FDA Drugs

FLULAVAL QUADRIVALENT

For active immunization of persons 6 months of age and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

Published: Jul 2, 2026 | Category: FDA | Name: FDA Biologics

Preventing Accidental Apoquel Chewable Overdoses

The FDA has received an increasing number of reports of pets accidentally overdosing on Apoquel Chewable (oclacitinib chewable tablets), a flavored chewable medicine approved only for dogs.

Published: Jul 2, 2026 | Category: FDA | Name: FDA Drugs

Coronavirus (COVID-19) | Drugs

CDER is engaged in numerous activities to protect and promote public health during the COVID-19 pandemic.

Published: Jul 1, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease

The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent β thalassemia (TDT).

Published: Jul 1, 2026 | Category: FDA | Name: FDA Press Release

Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot CL6814 through December 31, 2026

This is to provide you with important information regarding Antivenin (Micrurus fulvius) (Equine Origin), commonly referred to as North American Coral Snake Antivenin. Antivenin (Micrurus fulvius) (Equine Origin) is indicated for treatment of envenomation by Micrurus fulvius fulvius (Eastern Coral

Published: Jul 1, 2026 | Category: FDA | Name: FDA Biologics

VAXCHORA

VAXCHORA is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1.

Published: Jul 1, 2026 | Category: FDA | Name: FDA Biologics

HAEGARDA

Product approval information is indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.

Published: Jul 1, 2026 | Category: FDA | Name: FDA Biologics

Erytype S

Product approval information is indicated for use on the Erytype® S Rh + K Type plate for Rh and Kell typing on the TANGO® optimo automated blood grouping and antibody test system. Blood Grouping Reagent, Anti-D (Monoclonal)(IgM) (Formulated for Automated Testing) is used as a component of the Eryt

Published: Jul 1, 2026 | Category: FDA | Name: FDA Biologics

MAGNUM Brand products may be harmful due to hidden drug ingredients

The Food and Drug Administration continues advising consumers not to purchase or use MAGNUM brand products sold for sexual enhancement across various websites and retail stores. FDA laboratory analysis has confirmed that MAGNUM brand products sold in various dosage forms including capsules and honey

Published: Jul 1, 2026 | Category: FDA | Name: FDA Drugs

BK261345- HIV Combo Next Assay

The HIV Combo Next assay is a chemiluminescent microparticle immunoassay (CMIA) used for the simultaneous qualitative detection of human immunodeficiency virus type 1 p24 antigen and antibodies to HIV-1 group M and O and/or HIV-2 in human serum and plasma (EDTA and heparin) on the Alinity i system.

Published: Jul 1, 2026 | Category: FDA | Name: FDA Biologics

Submitting Next-Generation Sequencing Data to the Division of Antiviral Products

Electronic Submissions and Clinical/Antimicrobial.

Published: Jul 1, 2026 | Category: FDA | Name: FDA Drugs

FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies

Published: Jun 30, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients

The U.S. Food and Drug Administration today approved TREGZI, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Published: Jun 30, 2026 | Category: FDA | Name: FDA Press Release

January - March 2026 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event Monitoring System (AEMS)

Published: Jun 30, 2026 | Category: FDA | Name: FDA Drugs

Genzyme Ireland Limited - 728681 - 06/22/2026

CGMP/Deviations/Biologics License Application (BLA)

Published: Jun 30, 2026 | Category: FDA | Name: FDA Biologics

Excelvision - 726714 - Fareva

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 30, 2026 | Category: FDA | Name: FDA Drugs

Wizcure Pharmaa Private Limited - 726378 - 06/24/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 30, 2026 | Category: FDA | Name: FDA Drugs

Yangzhou Hongshengding Chemical Co., Ltd. - 729710 - 06/15/2026

Refusal to Provide Access to and Copying of Records

Published: Jun 30, 2026 | Category: FDA | Name: FDA Drugs

Towards Longer-Acting Factor VIII Products with Better Purity

A description of Andrey Sarafanov's research program and related publications.

Published: Jun 30, 2026 | Category: FDA | Name: FDA Biologics

Evaluation of Therapeutic Approaches Based on Genome Editing and Stem Cell Technologies

Zhaohui Ye's research project "Evaluation of Therapeutic Approaches Based on Genome Editing and Stem Cell Technologies".

Published: Jun 29, 2026 | Category: FDA | Name: FDA Biologics

Immunogenicity of Gene Therapy Products

Ronit Mazor's research project "Immunogenicity of Gene Therapy Products".

Published: Jun 29, 2026 | Category: FDA | Name: FDA Biologics

Drug Trials Snapshots: PALSONIFY

PALSONIFY is a somatostatin receptor analog for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.

Published: Jun 29, 2026 | Category: FDA | Name: FDA Drugs

FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing

FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain.

Published: Jun 29, 2026 | Category: FDA | Name: FDA Press Release

ORALAIR

Product approval information for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in p

Published: Jun 29, 2026 | Category: FDA | Name: FDA Biologics

Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus

We, FDA, are notifying you, blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, that we have determined Ebola disease to be a transfusion-transmitted infection (TTI) under Title 21 of the Code of Federal Regulations (CFR) 630.

Published: Jun 29, 2026 | Category: FDA | Name: FDA Biologics

Drug Trials Snapshots: YARTEMLEA

YARTEMLEA is a prescription drug that is a MASP-2 inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).

Published: Jun 29, 2026 | Category: FDA | Name: FDA Drugs

2026 Meeting Materials, Cellular, Tissue, and Gene Therapies Advisory Committee

This is the main page for the 2026 Meeting Materials for the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC).

Published: Jun 29, 2026 | Category: FDA | Name: FDA Biologics

Cellular, Tissue, and Gene Therapies Advisory Committee July 29, 2026 Meeting Announcement - 07/29/2026

This is the main page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) July 29, 2026 announcement and meeting materials.

Published: Jun 29, 2026 | Category: FDA | Name: FDA Biologics

Center for Drug Evaluation and Research and the Office of the Chief Scientist Cosmetic Agreement

This document outlines a working agreement between the Center for Drug Evaluation and Research (CDER) and the Office of the Chief Scientist.

Published: Jun 26, 2026 | Category: FDA | Name: FDA Drugs

FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health

The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would help protect the public health of Americans, including youth, by strengthening the agency’s ability to efficiently identify illegal foreign tobacco products — including youth-appealing e-cigarettes — and con

Published: Jun 26, 2026 | Category: FDA | Name: FDA Press Release

Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers

Guidance for Industry - Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers, Procedural

Published: Jun 26, 2026 | Category: FDA | Name: FDA Drugs

Model-Integrated Evidence (MIE) Industry Meeting Pilot Between FDA and Generic Drug Applicants

Prospective generic drug applicants and generic drug applicants who intend to use model-integrated evidence (MIE) approaches for bioequivalence (BE) establishment in their abbreviated new drug applications (ANDAs).

Published: Jun 25, 2026 | Category: FDA | Name: FDA Drugs

Adacel

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

Published: Jun 24, 2026 | Category: FDA | Name: FDA Biologics

Drug Trials Snapshots webpage

Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparent.

Published: Jun 24, 2026 | Category: FDA | Name: FDA Drugs

BK261357- SeCore CDx HLA Sequencing System

The SeCore CDx HLA Sequencing System is intended for the detection of human leukocyte antigen A-locus (HLA-A) alleles using genomic DNA isolated from whole blood samples.

Published: Jun 24, 2026 | Category: FDA | Name: FDA Biologics

FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer

Published: Jun 24, 2026 | Category: FDA | Name: FDA Drugs

Vaccinia Immune Globulin Intravenous (Human)

Product approval information is indicated for treatment and/or modification of the following conditions, which are complications resulting from smallpox vaccination o Eczema vaccinatum o Progressive vaccinia o Severe generalized vaccinia o Vaccinia infections in individuals who have skin conditions

Published: Jun 24, 2026 | Category: FDA | Name: FDA Biologics

VARIVAX (refrigerated and frozen formulations)

Product approval information for Varicella Virus Vaccine Live also known as Varivax.

Published: Jun 24, 2026 | Category: FDA | Name: FDA Biologics

LUXTURNA

Is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Patients must have viable retinal cells as determined by the treating physician(s).

Published: Jun 24, 2026 | Category: FDA | Name: FDA Biologics

PRE-FORMANCE BLACK may be harmful due to hidden ingredient

The Food and Drug Administration is advising consumers not to purchase or use PRE-FORMANCE BLACK, a product promoted to boost energy and increase performance on various websites, including Advancedsupps.com, and possibly in some retail stores.

Published: Jun 24, 2026 | Category: FDA | Name: FDA Drugs

WILATE

In adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and for on-demand treatment and control of bleeding episodes.

Published: Jun 24, 2026 | Category: FDA | Name: FDA Biologics

FDA Approves First Treatment Shown to Reduce the Risk of Acute Pancreatitis in Adults with Severe Hypertriglyceridemia

The U.S. Food and Drug Administration (FDA) has approved Tryngolza (olezarsen), used with diet, to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia.

Published: Jun 24, 2026 | Category: FDA | Name: FDA Drugs

Zostavax

Product approval information for Zoster Vaccine also know as Zostavax. Zostavax is a FDA licensed vaccine that helps to reduce the risk of getting herpes zoster or shingles in individuals 50 years of age and older.

Published: Jun 24, 2026 | Category: FDA | Name: FDA Biologics

FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer

On June 24, 2026, the Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer follo

Published: Jun 24, 2026 | Category: FDA | Name: FDA Drugs

IND Application Reporting: IND Safety Reports

This webpage provides an overview of investigational new drug application (IND) safety reporting requirements for sponsors set forth in 21 CFR 312.32 and additional resources, including FDA guidances, related to these requirements.

Published: Jun 23, 2026 | Category: FDA | Name: FDA Drugs

BK251252- MEDIFLY Maggots

MEDIFLY Maggots are indicated for debridement of non-healing necrotic skin and soft tissue wounds, including pressure ulcers, neuropathic foot ulcers, and non-healing traumatic or post-surgical wounds.

Published: Jun 23, 2026 | Category: FDA | Name: FDA Biologics

Guidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

Published: Jun 23, 2026 | Category: FDA | Name: FDA Drugs

Office of New Drugs Standard Safety Tables and Figures for New Drug and Biologic Applications - 06/23/2026

Webinar on the standard safety tables and figures integrated guide and MAPP for the premarket safety evaluation of new drug and biologic products

Published: Jun 23, 2026 | Category: FDA | Name: FDA Drugs

Office of New Drugs Custom Medical Queries (OCMQs) for Safety Signal Detection in Clinical Trial Data - 06/23/2026

The goal of this webinar is to provide general audiences information on the development and use of Office of New Drugs (OND) Custom Medical Queries (OCMQs) during premarket safety evaluation. OCMQs are standardized groupings of adverse event terms designed to help identify potential safety issues during review of clinical trial adverse event data a

Published: Jun 23, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves First Generic of Priftin (rifapentine) Tablets

The U.S. Food and Drug Administration has approved the first generic of Priftin (rifapentine) tablets, a medication for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more antituberculosis drugs.

Published: Jun 23, 2026 | Category: FDA | Name: FDA Drugs

Amazon.com, Inc. - 728814 - 06/17/2026

Unapproved New Drugs/Misbranded

Published: Jun 23, 2026 | Category: FDA | Name: FDA Drugs

Huons Co., Ltd. - 724650 - 06/15/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 23, 2026 | Category: FDA | Name: FDA Drugs

Jubilant HollisterStier General Partnership - 723537 - 05/28/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 23, 2026 | Category: FDA | Name: FDA Drugs

Imu-Tek Animal Health, Incorporated - 724610 - 06/05/2026

Dietary Supplement/New Drug/Misbranded

Published: Jun 23, 2026 | Category: FDA | Name: FDA Drugs

Wholesale Peptide - 729447 - 06/17/2026

Unapproved New Drugs/Misbranded

Published: Jun 23, 2026 | Category: FDA | Name: FDA Drugs

Herbal Dermals LLC FZ dba Gotucream - 729043 - 06/17/2026

Unapproved New Drugs/Misbranded

Published: Jun 23, 2026 | Category: FDA | Name: FDA Drugs

4U Health - 720527 - 06/16/2026

Premarket Approval/Adulterated

Published: Jun 23, 2026 | Category: FDA | Name: FDA Biologics

Kimera Labs, Inc. - 649343 - 06/12/2026

Investigational Device Exemptions (IDE)

Published: Jun 23, 2026 | Category: FDA | Name: FDA Biologics

Select CBER Projects and Activities

CBER projects and activities that address the 21st Century Cures Act and the Prescription Drug User Fees Act VI Reauthorization (PDUFA VI) as authorized by the FDA Reauthorization Act (FDARA)

Published: Jun 23, 2026 | Category: FDA | Name: FDA Biologics

COVID-19 Vaccine Safety Surveillance

This page describes the monitoring the safety of authorized COVID-19 vaccines through both passive and active safety surveillance systems.

Published: Jun 22, 2026 | Category: FDA | Name: FDA Biologics

Publications & Presentations

Transparency is a fundamental principle of the operations of the CBER Surveillance Program including the BEST Initiative, Sentinel System, CMS collaboration, and others.

Published: Jun 22, 2026 | Category: FDA | Name: FDA Biologics

Tissues & Advanced Therapeutics

Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P.

Published: Jun 22, 2026 | Category: FDA | Name: FDA Biologics

Blood & Blood Products

The Center for Biologics Evaluation and Research (CBER) regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes standards for the products themselves.

Published: Jun 22, 2026 | Category: FDA | Name: FDA Biologics

Vaccines & Allergenics

The Center for Biologics Evaluation and Research (CBER) regulates vaccine products. Many of these are childhood vaccines that have contributed to a significant reduction of vaccine-preventable diseases.

Published: Jun 22, 2026 | Category: FDA | Name: FDA Biologics

Artificial Intelligence and Natural Language Processing

Published: Jun 22, 2026 | Category: FDA | Name: FDA Biologics

FDA’s Survey of Health and Patient Experience SHAPE Platform

The FDA Survey of Health and Patient Experience (SHAPE) Platform was developed as part of the FDA CBER’s Biologics Effectiveness and Safety (BEST) Innovative Methods (IM) initiative. SHAPE is a versatile and scalable platform designed to support the collection of patient experience data.

Published: Jun 22, 2026 | Category: FDA | Name: FDA Biologics

Privacy & Security

Data privacy and security of individuals are of paramount concern to the FDA and to all BEST Collaborating Institutions. BEST’s privacy and data security policies are described in greater detail in the BEST statement of Principles and Policies (coming soon).

Published: Jun 22, 2026 | Category: FDA | Name: FDA Biologics

Outcomes

To identify adverse events (AEs) or health outcomes of interest (HOIs) in health care databases including administrative claims, electronic health records [EHR], and linked claims-EHRs, rule-based algorithms are developed utilizing reimbursement or health care management coding systems as well as cl

Published: Jun 22, 2026 | Category: FDA | Name: FDA Biologics

Distributed Network and Common Data Model

The BEST Initiative infrastructure is constructed as a distributed network of data providers and scientific collaborators.

Published: Jun 22, 2026 | Category: FDA | Name: FDA Biologics

Events & Engaging Stakeholders

The BEST Initiative encourages engagement and interaction among its diverse collaborators and provides opportunities for such partnerships.

Published: Jun 22, 2026 | Category: FDA | Name: FDA Biologics

Other CBER Surveillance Programs

Published: Jun 22, 2026 | Category: FDA | Name: FDA Biologics

BEST Innovative Methods Exchange Platform

Published: Jun 22, 2026 | Category: FDA | Name: FDA Biologics

Collaborators

Biologics Effectiveness and Safety (BEST) Collaborating Institutions

Published: Jun 22, 2026 | Category: FDA | Name: FDA Biologics

FDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development

Learn more about actions to accelerate and modernize clinical research across the full continuum of drug development —from the Investigational New Drug (IND) phase to late-stage pivotal trials.

Published: Jun 22, 2026 | Category: FDA | Name: FDA Drugs

Phase 1 Investigational New Drug (IND) Navigator

The Phase 1 IND Navigator provides the tools, guidances, and regulatory expertise you need to prepare and submit an successful Investigational New Drug (IND) application.

Published: Jun 22, 2026 | Category: FDA | Name: FDA Drugs

Phase 1 IND Federal Regulations

Information on Federal Regulations related to Phase 1 INDs

Published: Jun 22, 2026 | Category: FDA | Name: FDA Drugs

Phase 1 IND Procedures and Policies

Find FDA procedures and policies related to Phase 1 IND submissions

Published: Jun 22, 2026 | Category: FDA | Name: FDA Drugs

Phase 1 IND Chemistry, Manufacturing, and Controls Flexibilities

Information on FDA's CMC regulatory flexibilities for Phase 1 INDs

Published: Jun 22, 2026 | Category: FDA | Name: FDA Drugs

Phase 1 IND Learning Resources

Find FDA learning resources related to Phase 1 IND submissions

Published: Jun 22, 2026 | Category: FDA | Name: FDA Drugs

Phase 1 IND Guidance Documents

Find FDA Guidance Documents related to Phase 1 IND submissions

Published: Jun 22, 2026 | Category: FDA | Name: FDA Drugs

Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials

Published: Jun 22, 2026 | Category: FDA | Name: FDA Drugs

Master Protocols for Drug and Biological Product Development

Published: Jun 22, 2026 | Category: FDA | Name: FDA Drugs

Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development

Published: Jun 22, 2026 | Category: FDA | Name: FDA Drugs

ZOLGENSMA

ZOLGENSMA (onasemnogene abeparvovec-xioi) is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.

Published: Jun 18, 2026 | Category: FDA | Name: FDA Biologics

¿Deben medicarse las encías de los bebés durante la dentición? No

La dentición es una fase normal de la infancia que no necesita “curarse” con medicamentos recetados o de venta libre. La FDA advierte a los padres que los productos que contienen benzocaína no son seguros para tratar la dentición en los niños. Hay alternativas no tóxicas más seguras.

Published: Jun 18, 2026 | Category: FDA | Name: FDA Drugs

Lessons Learned from our Roundtable with Rare Disease Advocates

Recently FDA leadership held a roundtable discussion with 15 dedicated rare disease leaders. Hearing directly from patients and family members who navigate these incredibly challenging conditions every day was both grounding and motivating.

Published: Jun 18, 2026 | Category: FDA | Name: FDA Drugs

Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug

Published: Jun 18, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves First Single-Dose Generic Treatment for Influenza

The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older.

Published: Jun 17, 2026 | Category: FDA | Name: FDA Press Release

Tebipenem Pivoxil – Oral Products

About Tebipenem Pivoxil

Published: Jun 17, 2026 | Category: FDA | Name: FDA Drugs

FDA approves first oral carbapenem therapy for complicated urinary tract infections

Published: Jun 17, 2026 | Category: FDA | Name: FDA Drugs

S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals

International Council on Harmonisation - Safety

Published: Jun 16, 2026 | Category: FDA | Name: FDA Drugs

2025 | Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA) - 07/11/2025

FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments for fiscal years 2028 through 2032.

Published: Jun 16, 2026 | Category: FDA | Name: FDA Drugs

Pharmathen International S.A. - 723680 - 05/27/2026

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Jun 16, 2026 | Category: FDA | Name: FDA Drugs

InvaDerm, Inc. - 713177 - 06/03/2026

Electronic Drug Registration and Listing System (eDRLS)/Violations

Published: Jun 16, 2026 | Category: FDA | Name: FDA Drugs

NativeMed LLC dba NativeMed - 728287 - 06/08/2026

False & Misleading Claims/Misbranded (Telehealth)

Published: Jun 16, 2026 | Category: FDA | Name: FDA Drugs

Eden Health International Inc. dba Eden - 728279 - 06/08/2026

False & Misleading Claims/Misbranded (Telehealth)

Published: Jun 16, 2026 | Category: FDA | Name: FDA Drugs

Altru Telehealth, LLC dba Altru Telehealth - 728274 - 06/08/2026

False & Misleading Claims/Misbranded (Telehealth)

Published: Jun 16, 2026 | Category: FDA | Name: FDA Drugs

FitRX, LLC dba AM RX - 728275 - 06/08/2026

False & Misleading Claims/Misbranded (Telehealth)

Published: Jun 16, 2026 | Category: FDA | Name: FDA Drugs

Amie Health, Inc. dba Amie - 728276 - 06/08/2026

False & Misleading Claims/Misbranded (Telehealth)

Published: Jun 16, 2026 | Category: FDA | Name: FDA Drugs

D&H Medical Services - 728238 - 06/08/2026

False & Misleading Claims/Misbranded (Telehealth)

Published: Jun 16, 2026 | Category: FDA | Name: FDA Drugs

Nexus Health Solutions LLC dba Harper Meds - 728281 - 06/08/2026

False & Misleading Claims/Misbranded (Telehealth)

Published: Jun 16, 2026 | Category: FDA | Name: FDA Drugs

HydraMed IV LLC dba HydraMed - 728282 - 06/08/2026

False & Misleading Claims/Misbranded (Telehealth)

Published: Jun 16, 2026 | Category: FDA | Name: FDA Drugs

Medica Weight Loss - 728284 - 06/08/2026

False & Misleading Claims/Misbranded (Telehealth)

Published: Jun 16, 2026 | Category: FDA | Name: FDA Drugs

Momentum Health 360 dba Momentum Health - 728286 - 06/08/2026

False & Misleading Claims/Misbranded (Telehealth)

Published: Jun 16, 2026 | Category: FDA | Name: FDA Drugs

FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose

The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose.

Published: Jun 16, 2026 | Category: FDA | Name: FDA Press Release

FDA Roundup: November 17, 2023

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Jun 16, 2026 | Category: FDA | Name: FDA Biologics

FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes

On June 12, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tzield (teplizumab) for a new indication, to delay the decline of insulin production in pediatric patients ages 8 through 17 years who have been recently diagnosed with Stage 3 type 1 diabetes (T1D).

Published: Jun 15, 2026 | Category: FDA | Name: FDA Press Release

Frequently Asked Questions About Drugs

Frequently Asked Questions About Drugs

Published: Jun 15, 2026 | Category: FDA | Name: FDA Drugs

Development of Antihypertensive Therapies for Use in Pediatric Patients - 07/15/2026

Treatment of chronic hypertension (high blood pressure) in pediatric patients remains an area of unmet medical need, with limited FDA-approved therapies, particularly for children younger than six years of age. Products are being developed to treat uncontrolled and/or resistant hypertension in adults that may have benefits in pediatric patients.

Published: Jun 15, 2026 | Category: FDA | Name: FDA Drugs

FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs

FDA is concerned about telehealth companies promoting compounded drugs, including glucagon-like peptide-1 receptor agonists (GLP-1s) and other drugs, with false or misleading claims.

Published: Jun 15, 2026 | Category: FDA | Name: FDA Drugs

Shipment Admissibility

FDA reviews drug shipments at land and seaports, courier hubs and international mail facilities to determine whether they are admissible into the U.S. FDA uses a multi-layered, risk-based approach to identify violative imported drugs, combining data screening and physical examinations.

Published: Jun 15, 2026 | Category: FDA | Name: FDA Drugs

Importing Investigational New Drugs

An investigational new drug (IND) imported for use in clinical studies must be covered by an IND application, unless exempt per 21 CFR 312.2. The company should submit the IND to FDA before importing the drug into the U.S.

Published: Jun 15, 2026 | Category: FDA | Name: FDA Drugs

Importing Active Pharmaceutical Ingredients

Active pharmaceutical ingredients (APIs) imported or offered for import into the U.S. must comply with all the applicable requirements and regulations under the Food Drug & Cosmetic (FD&C) Act and Title 21 of the Code of Federal Regulations (21 CFR).

Published: Jun 15, 2026 | Category: FDA | Name: FDA Drugs

Importing Drugs with a Pre-Launch Activities Importation Request (PLAIR)

FDA reviews requests and may grant permission in certain circumstances for a manufacturer to import a drug in anticipation of the drug receiving FDA approval. When approved, these pre-launch activities importation requests, or PLAIRs, allow drug sponsors to import unapproved finished drugs.

Published: Jun 15, 2026 | Category: FDA | Name: FDA Drugs

Importing Over-The-Counter Drugs

Over-the-counter (OTC) or non-prescription drugs imported into the U.S. must comply with all the applicable requirements under the Federal, Food and Cosmetic Act (FD&C Act) and the pertinent regulations in Title 21 of the Code of Federal Regulations (21 CFR).

Published: Jun 15, 2026 | Category: FDA | Name: FDA Drugs

Human Drug Importation Resources for Industry

This page provides a list of resources to help industry understand and comply with the applicable regulatory requirements to import human drugs into the U.S.

Published: Jun 15, 2026 | Category: FDA | Name: FDA Drugs

General Requirements for Importing Human Drugs

FDA verifies that drugs imported or offered for import into the U.S. meet federal law requirements at the time of import to protect patients and consumers.

Published: Jun 15, 2026 | Category: FDA | Name: FDA Drugs

Importing Prescription Drugs

Prescription drugs imported into the U.S. must comply with all the applicable requirements under the Federal, Food and Cosmetic Act (FD&C Act) and the pertinent regulations in Title 21 of the Code of Federal Regulations (21 CFR).

Published: Jun 15, 2026 | Category: FDA | Name: FDA Drugs

Tissue & Advanced Therapies Research

This page is about Tissue & Advanced Therapies Research

Published: Jun 12, 2026 | Category: FDA | Name: FDA Biologics

FDA Approves Drug for Pediatric Stage 3 Type I Diabetes

The U.S. Food and Drug Administration (FDA) has approved Tzield (teplizumab) injection to delay (slow down) the loss of the body’s own insulin production for pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 Type I diabetes (T1D).

Published: Jun 12, 2026 | Category: FDA | Name: FDA Drugs

Blood Research

List of Blood Research Programs in Biologics

Published: Jun 12, 2026 | Category: FDA | Name: FDA Biologics

FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children

The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an integrated CGM (iCGM) indicated for people two years of age and older who do not use insulin.

Published: Jun 12, 2026 | Category: FDA | Name: FDA Press Release

FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer

On June 12, 2026, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive p

Published: Jun 12, 2026 | Category: FDA | Name: FDA Drugs

Beekeeper’s Naturals Issues Voluntary Nationwide Recall of Beekeeper’s Naturals Saline Nasal Spray Sold Through Amazon Due to Microbial Contamination

FOR IMMEDIATE RELEASE – June 11, 2026, Covina, CA - Beekeeper’s Naturals is voluntarily recalling lot # 5950, Exp. Date 02/2028 of Beekeeper’s Naturals Saline Nasal Spray, sold only through Amazon, to the consumer level. This lot, produced at a third-party manufacturer, tested above our acceptable

Published: Jun 12, 2026 | Category: FDA | Name: FDA Drugs

FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma

On June 12, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the adjuvant treatment of adults with renal cell

Published: Jun 12, 2026 | Category: FDA | Name: FDA Drugs

January - March 2022 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

Published: Jun 12, 2026 | Category: FDA | Name: FDA Drugs

July - September 2022 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

Published: Jun 12, 2026 | Category: FDA | Name: FDA Drugs

October - December 2022 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

Published: Jun 12, 2026 | Category: FDA | Name: FDA Drugs

April - June 2022 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

Published: Jun 12, 2026 | Category: FDA | Name: FDA Drugs

October - December 2024 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

Published: Jun 12, 2026 | Category: FDA | Name: FDA Drugs

January - March 2024 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

Published: Jun 12, 2026 | Category: FDA | Name: FDA Drugs

April - June 2024 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

Published: Jun 12, 2026 | Category: FDA | Name: FDA Drugs

July - September 2024 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

Published: Jun 12, 2026 | Category: FDA | Name: FDA Drugs

January - March 2021 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

Published: Jun 12, 2026 | Category: FDA | Name: FDA Drugs

October - December 2020 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

Published: Jun 12, 2026 | Category: FDA | Name: FDA Drugs

April – June 2015 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

Published: Jun 12, 2026 | Category: FDA | Name: FDA Drugs

Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act

Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extension.

Published: Jun 11, 2026 | Category: FDA | Name: FDA Drugs

S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers

International Council for Harmonisation - Safety

Published: Jun 11, 2026 | Category: FDA | Name: FDA Drugs

Meeting 2: Patient and Care Partner Perspectives on Early Enrollment into Gene Therapy Clinical Trials for Rare Diseases

Gene therapy trials inform risks & benefits for informed decisions. Long-term follow-up crucial for safety & durability assessment.

Published: Jun 11, 2026 | Category: FDA | Name: FDA Biologics

Allergenics Research

List of Immunobiochemistry and Biologics Science & Research for Consumers - Allergenics Research

Published: Jun 11, 2026 | Category: FDA | Name: FDA Biologics

Meeting 1: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases - 09/20/2024

FDA CBER Patient Listening Meeting: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases

Published: Jun 11, 2026 | Category: FDA | Name: FDA Biologics

Meningitis Outbreak: Voriconazole and Liposomal Amphotericin B Availability Information

Voriconazole and Liposomal Amphotericin B Availability Information

Published: Jun 11, 2026 | Category: FDA | Name: FDA Drugs

Additional Information on Transmucosal Immediate Release Fentanyl (TIRF) REMS

Published: Jun 11, 2026 | Category: FDA | Name: FDA Drugs

ClinicalTrials.gov: Essentials for Academic Medical Centers - 07/14/2026

This virtual training is designed to help staff at academic medical centers meet the federal requirements for registering clinical studies and reporting results on ClinicalTrials.gov.

Published: Jun 11, 2026 | Category: FDA | Name: FDA Drugs

FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats

FDA today issued an Emergency Use Authorization (EUA) for generic Nitenpyram Tablets (nitenpyram) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and kittens that weigh at least two pounds and are at least four weeks old.

Published: Jun 11, 2026 | Category: FDA | Name: FDA Press Release

FDA notification regarding unapproved drugs included in kits

On September 20, 2024, FDA requested Azurity Pharmaceuticals Inc. stop distributing unapproved drugs marketed as “Unit-of-Use Prescription Compounding Kits.

Published: Jun 10, 2026 | Category: FDA | Name: FDA Drugs

Business Pill may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Business Pill, a product promoted and sold for male sexual enhancement on various websites, including https://supplx.com, and possibly in some retail stores.

Published: Jun 10, 2026 | Category: FDA | Name: FDA Drugs

Branch Manager for Men may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Branch Manager for Men, a product promoted and sold for male sexual enhancement on various websites, including https://supplx.com, and possibly in some retail stores.

Published: Jun 10, 2026 | Category: FDA | Name: FDA Drugs

Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans

Published: Jun 10, 2026 | Category: FDA | Name: FDA Drugs

Asanuma Corporation - 721136 - Sagamihara Factory

CGMP/OTC Finished Pharmaceuticals/Adulterated

Published: Jun 10, 2026 | Category: FDA | Name: FDA Drugs

Shantou Qiwei Industry Co., LTD - 721753 - 06/02/2026

CGMP/OTC Finished Pharmaceuticals/Adulterated

Published: Jun 10, 2026 | Category: FDA | Name: FDA Drugs

PLZ Corp - 721140 - 06/02/2026

CGMP/OTC Finished Pharmaceuticals/Adulterated

Published: Jun 10, 2026 | Category: FDA | Name: FDA Drugs

Erkul Kozmetik Sanayi ve Ticaret A.S. - 721964 - 06/02/2026

CGMP/OTC Finished Pharmaceuticals/Adulterated

Published: Jun 10, 2026 | Category: FDA | Name: FDA Drugs

Revlon Group Holdings, LLC - 722596 - 06/02/2026

CGMP/OTC Finished Pharmaceuticals/Adulterated

Published: Jun 10, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury

The FDA has approved changes to the Drugs Facts Label of the over-the-counter (OTC) weight loss drug, alli (orlistat) 60 mg capsules, to warn of risks of acute kidney injury, which is a rare side effect of the medication. The labeling now advises consumers to ask a health care provider before using

Published: Jun 10, 2026 | Category: FDA | Name: FDA Drugs

510(k) Blood Establishment Computer Software - 2026

Listing of 510(k) Blood Establishment Computer Software for the year 2026

Published: Jun 10, 2026 | Category: FDA | Name: FDA Biologics

BK261333- Blood Product Questionnaire Module (v2.0.0)

The Blood Product Questionnaire Module supports single and/or multi-site blood establishment collection facilities’ creation of a donor history questionnaire, the collection of donor history, the determination of visit requirements, the determination of donor eligibility, and unit suitability.

Published: Jun 10, 2026 | Category: FDA | Name: FDA Biologics

Contacts in the Center for Biologics Evaluation & Research (CBER)

List of contact information in the Center for Biologics Evaluation & Research (CBER)

Published: Jun 10, 2026 | Category: FDA | Name: FDA Biologics

Adnan M. Dahdul, M.D. - 719607 - 05/15/2026

Clinical Investigator/BIMO

Published: Jun 9, 2026 | Category: FDA | Name: FDA Biologics

Consumer and Health Care Professional Information

Compounded drugs can serve an important medical need for patients who cannot be treated with an FDA-approved drug, such as a patient who has an allergy and needs a drug to be made without a certain dye, or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form.

Published: Jun 9, 2026 | Category: FDA | Name: FDA Drugs

Mitigating Risks of Compounded Drugs Through Surveillance

Mitigating Risks of Compounded Drugs Through Surveillance&#58; The FDA reviews adverse event and product quality reports, and takes action to mitigate identified risks. We also raise awareness about risks related to human drug compounding.

Published: Jun 9, 2026 | Category: FDA | Name: FDA Drugs

Compounding Safety Information: Quinacrine Hydrochloride

Quinacrine appears on the FDA 503B list of bulk drug substances that may be used in ccompounded drugs. FDA’s review for the 503B Bulks List determined that there is a clinical need for drug products compounded from quinacrine in the treatment of some patients with cutaneous lupus erythematosus.

Published: Jun 9, 2026 | Category: FDA | Name: FDA Drugs

About HIV and the Center for Drug Evaluation and Research's role

Learn what HIV is and how CDER is working to prevent and treat HIV infections

Published: Jun 9, 2026 | Category: FDA | Name: FDA Drugs

Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil - 645478 - 06/05/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 9, 2026 | Category: FDA | Name: FDA Drugs

Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil - 645478 - 02/13/2023

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 9, 2026 | Category: FDA | Name: FDA Drugs

Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil - 614402 - 06/05/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 9, 2026 | Category: FDA | Name: FDA Drugs

Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil - 614402 - 07/08/2021

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 9, 2026 | Category: FDA | Name: FDA Drugs

Gopaldas Visram & Co., Ltd. - 721755 - 06/02/2026

CGMP/OTC Finished Pharmaceuticals/Adulterated

Published: Jun 9, 2026 | Category: FDA | Name: FDA Drugs

FDA Expands Sunscreen Options for the First Time in 20 Years

Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency's efforts to advance sunscreen innovation.

Published: Jun 9, 2026 | Category: FDA | Name: FDA Press Release

Hubei Gedian Humanwell Pharmaceutical Co., Ltd. - 725591 - 06/03/2026

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Jun 9, 2026 | Category: FDA | Name: FDA Drugs

Fagron BV - 724551 - 05/12/2026

Compounding Pharmacy/Adulterated Drug Products

Published: Jun 9, 2026 | Category: FDA | Name: FDA Drugs

Zydus Lifesciences Limited - 722576 - 06/02/2026

Request for Records/CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 9, 2026 | Category: FDA | Name: FDA Drugs

Umendra Life Sciences Private Limited - 721752 - 06/02/2026

CGMP/OTC Finished Pharmaceuticals/Adulterated

Published: Jun 9, 2026 | Category: FDA | Name: FDA Drugs

Laboratorios Dr. Collado S.A. - 723285 - 06/02/2026

CGMP/OTC Finished Pharmaceuticals/Adulterated

Published: Jun 9, 2026 | Category: FDA | Name: FDA Drugs

Macau-Union Pharmaceutical Limited - 724506 - 05/29/2026

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drugs/Misbranded

Published: Jun 9, 2026 | Category: FDA | Name: FDA Drugs

Jose M. Carpio, M.D. - 730966 - 05/28/2026

Clinical Investigator

Published: Jun 9, 2026 | Category: FDA | Name: FDA Drugs

VISTASEAL

Fibrin Sealant lead page - FIBRIN SEALANT (Human) is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. FIBRIN SEALANT (Human)

Published: Jun 8, 2026 | Category: FDA | Name: FDA Biologics

2022 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments - 06/07/2022

The Food and Drug Administration (FDA or the Agency) is announcing its annual public meeting and opportunity for public comment on “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.”

Published: Jun 8, 2026 | Category: FDA | Name: FDA Drugs

BsUFA II: Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act

Over the years, FDA has worked to increase communication between Agency staff and applicants during the review of novel drug and original biologic applications. The goal has been to enhance the transparency, predictability, effectiveness, and efficiency of the review process.

Published: Jun 8, 2026 | Category: FDA | Name: FDA Drugs

BD Issues Nationwide Recall for Specific Lots of ChloraPrep™ Clear Single Sterile 1 mL and FREPP™ Clear 1.5 mL Applicators Due to Microbial Contamination

FRANKLIN LAKES, N.J. (June 06, 2026) – BD (Becton, Dickinson and Company) is voluntarily recalling lot 4032183 of ChloraPrep™ Clear 1 mL Single Sterile and lot 4073005 of FREPP™ Clear 1.5 mL applicators with paper lidding to the consumer level. These products are being recalled due to fungal contami

Published: Jun 8, 2026 | Category: FDA | Name: FDA Drugs

Hepatitis C Medicines (Mavyret, Zepatier, and Vosevi): Drug Safety Communication - Due to Rare Occurrence of Serious Liver Injury in Some patients with Advanced Liver Disease

FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure.

Published: Jun 8, 2026 | Category: FDA | Name: FDA Drugs

Ensuring Quality and Access: FDA’s Approach to Generic Drug Oversight

The agency continues to prioritize the speed and efficiency with which generic drugs are regulated, while balancing the need for minimizing risk and ensuring access to quality medications.

Published: Jun 8, 2026 | Category: FDA | Name: FDA Drugs

Generic Drugs: Questions & Answers

A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.

Published: Jun 8, 2026 | Category: FDA | Name: FDA Drugs

Pink Pussycat Brand products may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Pink Pussycat Aphrodisiac Chocolate, a product promoted and sold for sexual enhancement on various websites, including loverslane.com, and possibly in some retail stores.

Published: Jun 5, 2026 | Category: FDA | Name: FDA Drugs

FDA Encourages Reintroduction of Bovine-Sourced Heparin

FDA encourages all prospective manufacturers and suppliers of bovine heparin and other animal-sourced products to develop good manufacturing process capability and related quality controls for their products. FDA welcomes engagement with sponsors considering use of such animal-sourced products throu

Published: Jun 5, 2026 | Category: FDA | Name: FDA Drugs

BK251274- RegenBMC® (RegenKit®-THT®-BMC)

The RegenBMC® system is indicated to be used intraoperatively at the point-of-care for the safe and rapid preparation of autologous platelet concentrate platelet-rich plasma (PRP) from a small sample of peripheral blood or a mixture of peripheral blood and bone marrow.

Published: Jun 5, 2026 | Category: FDA | Name: FDA Biologics

BK261335- LIAISON® MUREX HIV Ab/Ag HT; LIAISON®XL; LIAISON® diluteX

The LIAISON® Murex HIV Ab/Ag HT is an in vitro chemiluminescent immunoassay for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (Groups Mand0) and HIV-2 in human serum (without or with gel-SST) or plasma.

Published: Jun 5, 2026 | Category: FDA | Name: FDA Biologics

BK261315- ELUclear Elution Kit

The ELUclear Elution Kit removes antibodies bound to red cell antigens through a controlled dissociated process.

Published: Jun 5, 2026 | Category: FDA | Name: FDA Biologics

Accelerating Product Development for Pediatric Systemic Lupus Erythematosus (SLE) - 07/30/2026

The U.S. Food and Drug Administration (FDA), with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), will host a workshop, “Accelerating Product Development for Pediatric Systemic Lupus Erythematosus” on July 30-31, 2026. This workshop will examine key similarities and differences between adult and pedia

Published: Jun 5, 2026 | Category: FDA | Name: FDA Drugs

Lipofit Extreme 2.0 Fat Burner may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Lipofit Extreme 2.0 Fat Burner, a product promoted and sold for weight loss on various websites, including https://anasalazar.us.com and possibly in some retail stores.

Published: Jun 4, 2026 | Category: FDA | Name: FDA Drugs

Juicy AF! may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Juicy AF!, a product promoted and sold for female sexual enhancement on various websites and in some retail stores.

Published: Jun 4, 2026 | Category: FDA | Name: FDA Drugs

FATZorb may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use FATZorb, a product promoted and sold for weight loss on various websites, including https://ebay.com and possibly in some retail stores.

Published: Jun 4, 2026 | Category: FDA | Name: FDA Drugs

Haleon Issues Voluntary Nationwide Recall of Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct.

WARREN, N.J., June 4, 2026 — Haleon (NYSE: HLN) is voluntarily recalling four lots of Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct. distributed on or about April 13, 2026 to the consumer level. The lots are being recalled due to potential contamination with a diluted propylene glycol-based

Published: Jun 4, 2026 | Category: FDA | Name: FDA Drugs

CDER Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs)

It has become increasingly clear that new approach methodologies (NAMs)—when combined with knowledge of the pathway, results of pharmacology studies, and other relevant data—may offer ways to reduce animal testing.

Published: Jun 4, 2026 | Category: FDA | Name: FDA Drugs

Certain Postapproval Requirements and Resources for ANDAs

Published: Jun 4, 2026 | Category: FDA | Name: FDA Drugs

Emergency Preparedness | Drugs

The Center for Drug Evaluation and Research (CDER) takes an active role in helping prepare the nation to respond to terrorist events, emerging health threats, and emergency response to natural and man-made crises.

Published: Jun 4, 2026 | Category: FDA | Name: FDA Drugs

Compounding Information for States

FDA collaborates with state officials in a variety of ways, including by sharing information about compounders who engage in poor practices that could put patients at risk, sharing information about complaints and adverse events, and sharing findings from inspections.

Published: Jun 3, 2026 | Category: FDA | Name: FDA Drugs

CDER Drug Approvals that Used Real-World Evidence

The Food and Drug Administration (FDA) uses real-world data (RWD) and real-world evidence (RWE) to support regulatory decision-making across the lifecycle of medical products, including premarket evaluation and postmarket monitoring of safety and effectiveness.

Published: Jun 3, 2026 | Category: FDA | Name: FDA Drugs

FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury

Published: Jun 3, 2026 | Category: FDA | Name: FDA Drugs

CBER Labeling Changes Related to Safety Findings that Used Real-World Evidence – FDA and Sponsor Conducted Studies

Published: Jun 3, 2026 | Category: FDA | Name: FDA Biologics

CBER Biological Product Approvals that Used Real-World Evidence

Published: Jun 3, 2026 | Category: FDA | Name: FDA Biologics

CDER Postmarketing Studies that Used Real-World Evidence

Published: Jun 3, 2026 | Category: FDA | Name: FDA Drugs

FDA/Health and Environmental Sciences Institute/Safety Pharmacology Society Hybrid Workshop: ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology - 07/28/2026

The US. Food and Drug Administration (FDA) in collaboration with the Health and Environmental Sciences Institute (HESI), and the Safety Pharmacology Society (SPS) will host a hybrid public workshop entitled “ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology” on July 28, 2026.

Published: Jun 2, 2026 | Category: FDA | Name: FDA Drugs

Inter-governmental Working Meeting on Drug Compounding, October 26-27, 2021

On October 26-27, 2021, U.S. Food and Drug Administration (FDA) convened its tenth inter-governmental working meeting on drug compounding. Attendees included officials from state boards of pharmacy and state health departments and representatives from the National Association of Boards of Pharmacy

Published: Jun 2, 2026 | Category: FDA | Name: FDA Drugs

Blue Horizon International, LLC - 728085 - 05/26/2026

Unapproved New Drugs/Unlicensed Biological Product Violations

Published: Jun 2, 2026 | Category: FDA | Name: FDA Biologics

Medline Inc - 724347 - 05/28/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 2, 2026 | Category: FDA | Name: FDA Drugs

Dough-To-Go, Inc. - 727845 - 05/12/2026

CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated

Published: Jun 2, 2026 | Category: FDA | Name: FDA Drugs

Meta Labs Pharmaceuticals, LLC - 725130 - 05/15/2026

Dietary Supplement/New Drug/Misbranded

Published: Jun 2, 2026 | Category: FDA | Name: FDA Drugs

Aeroflex Industria de Aerosol Ltda. - 728186 - 05/22/2026

Refusal to Provide Access to and Copying of Records

Published: Jun 2, 2026 | Category: FDA | Name: FDA Drugs

Laboratorios Jaloma S.A. de C.V. - 725939 - 05/22/2026

CGMP/OTC/Finished Pharmaceuticals/Adulterated

Published: Jun 2, 2026 | Category: FDA | Name: FDA Drugs

HealthPartners Neuroscience Center Research and Innovation - 725333 - 05/19/2026

Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies

Published: Jun 2, 2026 | Category: FDA | Name: FDA Drugs

FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of existing scientific and regulatory knowledge.

Published: Jun 2, 2026 | Category: FDA | Name: FDA Press Release

Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers

Guidance for Industry and Review Staff - Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers, Procedural

Published: Jun 2, 2026 | Category: FDA | Name: FDA Drugs

Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing

This is the Draft Guidance for Industry, Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing

Published: Jun 2, 2026 | Category: FDA | Name: FDA Biologics

M15 General Principles for Model-Informed Drug Development

Published: Jun 2, 2026 | Category: FDA | Name: FDA Drugs

Generic Drug Facts

Information on how generic medicines have the same safety, effectiveness, and high quality as brand name medicines.

Published: Jun 2, 2026 | Category: FDA | Name: FDA Drugs

FDA Science, Research, and Collaboration Advance Generic Medicines

In 2023, GDUFA-funded research helped expand our understanding of generic drug products, including complex products, and contributed to the development of advanced methods to characterize product quality and performance.

Published: Jun 1, 2026 | Category: FDA | Name: FDA Drugs

SEVENFACT

Treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors

Published: Jun 1, 2026 | Category: FDA | Name: FDA Biologics

COAGADEX

•Indicated in adults and children with hereditary Factor X deficiency for: ◦Routine prophylaxis to reduce the frequency of bleeding episodes ◦On-demand treatment and control of bleeding episodes ◦Perioperative management of bleeding in patients with mild and moderate hereditary Factor X deficiency

Published: Jun 1, 2026 | Category: FDA | Name: FDA Biologics

IDELVION

Product approval information is indicated for children and adults with hemophilia B (congenital Factor IX deficiency) for 1) On-demand control and prevention of bleeding episodes; 2) Perioperative management of bleeding; 3) Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Published: Jun 1, 2026 | Category: FDA | Name: FDA Biologics

IXINITY

Indicated in adults and children ≥ 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management.

Published: Jun 1, 2026 | Category: FDA | Name: FDA Biologics

BeneFIX

Product approval information is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease)

Published: Jun 1, 2026 | Category: FDA | Name: FDA Biologics

X10 Natural Enhancement Supplement may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use X10 Natural Enhancement Supplement, a product promoted for sexual enhancement on various websites, including naturefuel.us, and possibly in some retail stores.

Published: May 29, 2026 | Category: FDA | Name: FDA Drugs

Big Dick Energy! may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Big Dick Energy!, a product promoted and sold for male sexual enhancement on various websites and possibly in some retail stores.

Published: May 29, 2026 | Category: FDA | Name: FDA Drugs

Micro Typing Systems A/B; MTS A/B/D; MTS A/B/D/Reverse and MTS Monoclonal Rh Phenotype Card

Manufacture of a "Monoclonal Rh Phenotype Card"

Published: May 29, 2026 | Category: FDA | Name: FDA Biologics

Erectus Plus may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Erectus Plus, a product promoted and sold for male sexual enhancement on various websites, including ebay.com, and possibly in some retail stores.

Published: May 29, 2026 | Category: FDA | Name: FDA Drugs

Baipho Herbs Tea Drink may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Baipho Herbs Tea Drink, a product promoted and sold for pain on various websites, including www.amazon.com and in some retail stores.

Published: May 29, 2026 | Category: FDA | Name: FDA Drugs

Sensual Miracle Honey may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Sensual Miracle Honey, a product promoted and sold for male sexual enhancement on various websites, including sensualhoneyusa.com, and possibly in some retail stores.

Published: May 29, 2026 | Category: FDA | Name: FDA Drugs

Tawon Liar contains hidden drug ingredient

Published: May 29, 2026 | Category: FDA | Name: FDA Drugs

FDA Rationale for Breakpoints Recognition Decision for Disk Diffusion: Azithromycin and Neisseria gonorrhoeae

FDA has identified the disk diffusion inhibition zone diameters based on correlation with the FDA azithromycin minimum inhibitory concentration (MIC) breakpoints for Neisseria gonorrhoeae.

Published: May 29, 2026 | Category: FDA | Name: FDA Drugs

Cefepime and Zidebactam Injection

About the Cefepime and Zidebactam Injection.

Published: May 29, 2026 | Category: FDA | Name: FDA Drugs

Q10 Pharmaceutical Quality System

International Council on Harmonisation - Quality

Published: May 29, 2026 | Category: FDA | Name: FDA Drugs

Q9(R1) Quality Risk Management

The purpose of this guidance is to offer a systematic approach to quality risk management for better, more informed, and timely decisions. It serves as a foundation that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, stand

Published: May 29, 2026 | Category: FDA | Name: FDA Drugs

Q8(R2) Pharmaceutical Development

International Council on Harmonisation - Quality

Published: May 29, 2026 | Category: FDA | Name: FDA Drugs

Q8, Q9, and Q10 Questions and Answers (R5)

International Council on Harmonisation - Quality

Published: May 29, 2026 | Category: FDA | Name: FDA Drugs

Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products

Published: May 29, 2026 | Category: FDA | Name: FDA Drugs

FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs

The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs.

Published: May 29, 2026 | Category: FDA | Name: FDA Press Release

Historical Information on REMS for Opioid Analgesics

Extended-release, long-acting (ER/LA), and immediate-release (IR) opioid analgesics are powerful pain-reducing medications that have both benefits as well as potentially serious risks. This page includes background and historical information on the risk evaluation and mitigation strategy (REMS) for

Published: May 28, 2026 | Category: FDA | Name: FDA Drugs

Antiseptic Meetings

Antiseptic meetings

Published: May 28, 2026 | Category: FDA | Name: FDA Drugs

Frequently Asked Question on Children’s Cough and Cold Medicines

Frequently Asked Question on Children’s Cough and Cold Medicines including homeopathic products.

Published: May 28, 2026 | Category: FDA | Name: FDA Drugs

New Safety Measures Announced for Opioid Analgesics, Prescription Opioid Cough Products, and Benzodiazepines

Published: May 28, 2026 | Category: FDA | Name: FDA Drugs

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

Learn about the FDA's Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) designed to curb opioid misuse by ensuring safe prescribing, dispensing, and patient monitoring practices. This initiative targets healthcare professionals and aims to improve patient safety and opioid education.

Published: May 28, 2026 | Category: FDA | Name: FDA Drugs

Encouraging Harm Reduction

To reduce overdoses, and morbidity and deaths from overdoses

Published: May 28, 2026 | Category: FDA | Name: FDA Drugs

FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer

On May 28, 2026, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).

Published: May 28, 2026 | Category: FDA | Name: FDA Drugs

BK261329- Erytra Eflexis

Erytra Eflexis is a fully automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel 8 cards technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Antibody Titration, Compatibility Tests, and Direct Antigl

Published: May 28, 2026 | Category: FDA | Name: FDA Biologics

Influenza (Flu) Antiviral Drugs and Related Information

Flu is a serious disease, caused by influenza viruses, that can lead to hospitalization and even death. Your best defense is vaccination, which provides important protection from flu and its potential complications.

Published: May 28, 2026 | Category: FDA | Name: FDA Drugs

Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application

Biopharmaceutics

Published: May 28, 2026 | Category: FDA | Name: FDA Drugs

Adnan M. Dahdul, M.D. - 719607 - 05/15/2026

Clinical Investigator/BIMO

Published: May 28, 2026 | Category: FDA | Name: FDA Biologics

Statistical Approaches to Establishing Bioequivalence

Published: May 28, 2026 | Category: FDA | Name: FDA Drugs

Strive Pharmacy Texas LLC dba Strive Pharmacy - 639220 - 05/13/2026

Compounding Pharmacy/Adulterated Drug Products

Published: May 28, 2026 | Category: FDA | Name: FDA Drugs

Vita Pharmacy, LLC dba Talon Pharmacy of Boerne - 639220 - 08/29/2022

Compounding Pharmacy/Adulterated Drug Products

Published: May 28, 2026 | Category: FDA | Name: FDA Drugs

biQ-FEL may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use biQ-FEL, a product promoted for sexual enhancement on various websites, including walmart.com and biqfelusa.com and possibly in some retail stores.

Published: May 27, 2026 | Category: FDA | Name: FDA Drugs

Finding and Learning about Side Effects (adverse reactions)

Learning about Side Effects -- From Minor to Life Threatening -- Unwanted or Unexpected Drug Reactions

Published: May 27, 2026 | Category: FDA | Name: FDA Drugs

FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy

Published: May 27, 2026 | Category: FDA | Name: FDA Drugs

Prescription Stimulant Medications

Information about FDA's work to address the impact of stimulant-related risks, including misuse, addiction, overdose, and diversion.

Published: May 27, 2026 | Category: FDA | Name: FDA Drugs

Frequently Asked Questions | Clozapine REMS Modification

The Clozapine REMS is a shared system REMS for all approved clozapine products.

Published: May 27, 2026 | Category: FDA | Name: FDA Drugs

Information on Clozapine

Clozapine (marketed as Clozaril, Fazaclo ODT, Versacloz and generics) is an antipsychotic medicine used to treat schizophrenia in patients whose symptoms are not controlled with standard antipsychotic drugs. Clozapine is also used in patients with recurrent suicidal behavior associated with schizoph

Published: May 27, 2026 | Category: FDA | Name: FDA Drugs

M12 Drug Interaction Studies

This guideline provides recommendation to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies during the development of a therapeutic product.

Published: May 27, 2026 | Category: FDA | Name: FDA Drugs

Guidance for Industry | M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk

M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk

Published: May 27, 2026 | Category: FDA | Name: FDA Drugs

Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry

International Council on Harmonisation - Quality

Published: May 27, 2026 | Category: FDA | Name: FDA Drugs

Q11 Development and Manufacture of Drug Substances

International Council on Harmonisation - Quality

Published: May 27, 2026 | Category: FDA | Name: FDA Drugs

M12 Drug Interaction Studies: Questions and Answers

Published: May 27, 2026 | Category: FDA | Name: FDA Drugs

Abuse-Deterrent Opioid Analgesics

Published: May 27, 2026 | Category: FDA | Name: FDA Drugs

Iodinated Contrast Media (ICM)

Published: May 27, 2026 | Category: FDA | Name: FDA Drugs

FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss

Published: May 26, 2026 | Category: FDA | Name: FDA Drugs

Endothelin Receptor Antagonist REMS Information

FDA has determined that a REMS is no longer necessary to ensure ERA medicines’ benefits outweigh the risk of EFT.

Published: May 26, 2026 | Category: FDA | Name: FDA Drugs

Information about Domperidone

Published: May 26, 2026 | Category: FDA | Name: FDA Drugs

Skip the Antibacterial Soap; Use Plain Soap and Water

There isn’t sufficient evidence to show that OTC antibacterial soaps are better at preventing illness than washing with plain soap and water. Washing your hands is easy, and it’s one of the most effective ways to prevent the spread of germs.

Published: May 26, 2026 | Category: FDA | Name: FDA Drugs

Acetaminophen

This is a consumer webpage focused on the safe use of over-the-counter acetaminophen-containing products.

Published: May 26, 2026 | Category: FDA | Name: FDA Drugs

Alchymars ICM SM Private Limited - 724429 - 05/21/2026

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: May 26, 2026 | Category: FDA | Name: FDA Drugs

GC America, Inc. - 727602 - 05/14/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: May 26, 2026 | Category: FDA | Name: FDA Drugs

Sato Pharmaceutical Co., Ltd. - 723059 - 05/18/2026

CGMP/Drugs/Adulterated/OTC

Published: May 26, 2026 | Category: FDA | Name: FDA Drugs

GSC Products, LLC - 729653 - 05/18/2026

Unapproved New Drugs/Misbranded/OTC

Published: May 26, 2026 | Category: FDA | Name: FDA Drugs

Adnan Dahdul, MD - 719607 - 03/12/2026

Clinical Investigator/BIMO

Published: May 26, 2026 | Category: FDA | Name: FDA Biologics

Aja Health and Wellness Inc. - 729644 - 05/18/2026

Unapproved New Drug/Misbranded

Published: May 26, 2026 | Category: FDA | Name: FDA Drugs

M11 Clinical Electronic Structured Harmonised Protocol

Published: May 22, 2026 | Category: FDA | Name: FDA Drugs

Blood Grouping Reagents - ORTHO Sera, ALBAclone

Product approval information is indicated for: •ORTHO Sera Anti-D (DVI) is for the in vitro detection of human Rh D (DVI) positive red blood cells by the direct agglutination test. Patients and neonates should not be tested with this reagent since it detects partial RhD (DVI). •ORTHO Sera Anti-D (IA

Published: May 22, 2026 | Category: FDA | Name: FDA Biologics

Diagast Bundled BLA 125615, 125619 to 125626

Published: May 22, 2026 | Category: FDA | Name: FDA Biologics

FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection

Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarring) or with compensated cirrhosis.

Published: May 22, 2026 | Category: FDA | Name: FDA Press Release

2025 First Generic Drug Approvals

Published: May 22, 2026 | Category: FDA | Name: FDA Drugs

HIV Treatment

Get information about drugs approved to treat HIV

Published: May 22, 2026 | Category: FDA | Name: FDA Drugs

Prescription to Nonprescription Switch List

Published: May 22, 2026 | Category: FDA | Name: FDA Drugs

FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer

Published: May 22, 2026 | Category: FDA | Name: FDA Drugs

Blood Grouping Reagents, Anti-Fya, Anti-Jka, Anti-Jkb, Anti-S, Anti-s, Anti-K, Anti-P1

Products approval information are designated as Rare Antisera for Column Agglutination Technology (RASCAT) Monoclonal Blood Grouping Reagents (BGRs) and are manufactured for use with the Ortho ID-Micro Typing System™.

Published: May 22, 2026 | Category: FDA | Name: FDA Biologics

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Announcement - 06/18/2026

The Committee will meet in open session to discuss and make recommendations on the safety and effectiveness of MFLUSIVA, with a requested indication in BLA STN 125869/0 for the prevention of influenza disease caused by influenza virus subtypes A and type B represented in the vaccine, in persons 50 years of age and older.

Published: May 22, 2026 | Category: FDA | Name: FDA Biologics

Drug Application Process for Nonprescription Drugs

There are two regulatory pathways to bring a nonprescription drug to market in the U.S. -- the drug application process and Over-the-Counter (OTC) Drug Review (OTC monograph) process.

Published: May 21, 2026 | Category: FDA | Name: FDA Drugs

CSL Behring - 716297 - 05/13/2026

Advertising & Promotional Labeling/Drugs/Biological Products

Published: May 21, 2026 | Category: FDA | Name: FDA Biologics

Surveillance: Post Drug-Approval Activities

Published: May 20, 2026 | Category: FDA | Name: FDA Drugs

Guidance, Compliance, & Regulatory Information

Looking for FDA Guidance, Compliance, & Regulatory Information? Web page provides quick links to a variety of topics including nicotine-containing products, human drug compounding, and the Sunscreen Innovation Act.

Published: May 20, 2026 | Category: FDA | Name: FDA Drugs

Reports & Budgets | CDER

Reports and budgets from CDER offices and divisions

Published: May 20, 2026 | Category: FDA | Name: FDA Drugs

Eco-NAMs Webinar Series | In Silico Approaches to Replace Acute Fish Toxicity - 05/28/2026

The series' third webinar, In silico approaches to replace acute fish toxicity, will feature presentations by Anna Lombardo, researcher at Istituto di Ricerche Farmacologiche “Mario Negri” and Paul Thomas, President, Model Developer and Expert Ecotoxicologist at KREATiS.

Published: May 20, 2026 | Category: FDA | Name: FDA Drugs

Laws, Regulations, Guidances, and Enforcement Actions

Prescription Drug Advertising and Promotional Labeling: Laws, Regulations, Guidances, and Enforcement Actions

Published: May 20, 2026 | Category: FDA | Name: FDA Drugs

Prescription Drug Advertising and Promotional Labeling

Published: May 20, 2026 | Category: FDA | Name: FDA Drugs

Prescription Drug Advertising and Promotional Labeling

Published: May 20, 2026 | Category: FDA | Name: FDA Drugs

Report a Product Quality Issue

The purpose of field alert reports (FARs) is to quickly identify quality defects in distributed drug products that may present a potential safety threat.

Published: May 20, 2026 | Category: FDA | Name: FDA Drugs

Report a Product Quality Issue

The purpose of field alert reports (FARs) is to quickly identify quality defects in distributed drug products that may present a potential safety threat.

Published: May 20, 2026 | Category: FDA | Name: FDA Drugs

FDA Warns Retailers Selling Illegal Tobacco Products That Look Like Everyday Products

Published: May 20, 2026 | Category: FDA | Name: FDA Press Release

Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations

Published: May 20, 2026 | Category: FDA | Name: FDA Drugs

Drug Development and Drug Interactions | Resources

Possible models for decision making, advisory committee meetings, presentations, preventable adverse reactions

Published: May 20, 2026 | Category: FDA | Name: FDA Drugs

Antibacterial Drug Development Task Force

The CDER Antibacterial Drug Development Task Force has been created to support the development of new antibacterial drugs.

Published: May 19, 2026 | Category: FDA | Name: FDA Drugs

BK261326- Viality™ Lipoaspirate Wash System for Aesthetic Body Contouring (Viality-1400)

The Viality™ Lipoaspirate Wash System is to be used to filter and wash aspirated, harvested, autologous adipose tissue for aesthetic body contouring.

Published: May 19, 2026 | Category: FDA | Name: FDA Biologics

BK261331- ORTHO Optix™ Reader

The ORTHO Optix™ Reader is a system designed to automate reaction grading, results interpretation and data management when performing in vitro immunohematology testing of human blood utilizing ID-MTS™ Gel card technology.

Published: May 19, 2026 | Category: FDA | Name: FDA Biologics

Hangzhou Yiqi Biotechnology Co., Ltd - 720707 - 04/15/2026

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: May 19, 2026 | Category: FDA | Name: FDA Drugs

Lus Essentials LLC - 728783 - 05/14/2026

Unapproved New Drugs/Misbranded

Published: May 19, 2026 | Category: FDA | Name: FDA Drugs

La Crema De Rebeca - 728782 - 05/14/2026

Unapproved New Drugs/Misbranded

Published: May 19, 2026 | Category: FDA | Name: FDA Drugs

JW Nutritional LLC - 722096 - 04/15/2026

CGMP/OTC Finished Pharmaceuticals/Adulterated

Published: May 19, 2026 | Category: FDA | Name: FDA Drugs

PolleyMed, LLC - 726018 - 05/14/2026

Unapproved New Drugs/Misbranded

Published: May 19, 2026 | Category: FDA | Name: FDA Drugs

Harbin Jixianglong Biotech Co., Ltd. - 723330 - 05/01/2026

CGMP/API/Adulterated and Misbranded Drugs

Published: May 19, 2026 | Category: FDA | Name: FDA Drugs

Naseem A. Jaffrani, M.D. - 729750 - 05/04/2026

Clinical Investigator

Published: May 19, 2026 | Category: FDA | Name: FDA Drugs

Sourav K. Mishra, M.D. / All India Institute of Medical Sciences - 724881 - 04/29/2026

In Vivo Bioavailability-Bioequivalence Studies – Clinical

Published: May 19, 2026 | Category: FDA | Name: FDA Drugs

Nephron SC, LLC - 634647 - 05/08/2026

Compounding Pharmacy/Adulterated Drug Products

Published: May 18, 2026 | Category: FDA | Name: FDA Drugs

Nephron SC Inc. - 634647 - 10/11/2022

CGMP/Finished Pharmaceuticals/Adulterated

Published: May 18, 2026 | Category: FDA | Name: FDA Drugs

FDA warns consumers not to use expired Amazon Basic Care Levonorgestrel 1.5 mg

As is standard practice, the FDA is notifying consumers not to use expired Amazon Basic Care Levonorgestrel 1.5 mg.

Published: May 15, 2026 | Category: FDA | Name: FDA Drugs

BOOSTRIX

Boostrix is a product approval indicated for Booster immunization against tetanus, diphtheria and pertussis as a single dose in individuals 10 years of age and older

Published: May 15, 2026 | Category: FDA | Name: FDA Biologics

KINRIX

Changes to your package insert to the Dosage and Administration section regarding visual inspection by the user for cracked vials or syringes prior to administration of the vaccine and non-use of product should those conditions exist.

Published: May 15, 2026 | Category: FDA | Name: FDA Biologics

PEDIARIX

indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as

Published: May 15, 2026 | Category: FDA | Name: FDA Biologics

FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer

On May 15, 2026, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu, Daiichi Sankyo, Inc.) for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for the neoadjuvant treatment of adults with HER2-positive (I

Published: May 15, 2026 | Category: FDA | Name: FDA Drugs

TWINRIX

Active immunization against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus.

Published: May 15, 2026 | Category: FDA | Name: FDA Biologics

INFANRIX

Product approval information for Diphtheria Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed also known as Infanrix.

Published: May 15, 2026 | Category: FDA | Name: FDA Biologics

Withdrawn | Infectious Disease Accelerated Approvals

Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint

Published: May 15, 2026 | Category: FDA | Name: FDA Drugs

FDA approves first interchangeable biosimilars to Simponi and Simponi Aria (golimumab) to treat rheumatoid arthritis and ulcerative colitis

FDA approved Immgolis (golimumab-sldi) as an interchangeable biosimilar biological product to Simponi (golimumab) and Immgolis Intri (golimumab-sldi) as an interchangeable biosimilar biological product to Simponi Aria (golimumab). Immgolis and Immgolis Intri are the first biosimilars approved for

Published: May 15, 2026 | Category: FDA | Name: FDA Drugs

Sâm Xương Khớp Ông Tiên may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Sâm Xương Khớp Ông Tiên, a product promoted and sold for pain on various websites.

Published: May 15, 2026 | Category: FDA | Name: FDA Drugs

ENGERIX-B

ENGERIX-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.

Published: May 15, 2026 | Category: FDA | Name: FDA Biologics

Dear Health Care Provider Letters: Improving Communication of Important Safety Information

Procedural

Published: May 15, 2026 | Category: FDA | Name: FDA Drugs

HAVRIX

For active immunization against disease caused by hepatitis A virus (HAV) for persons 12 months of age and older.

Published: May 15, 2026 | Category: FDA | Name: FDA Biologics

CDER Ombuds

The CDER Ombuds receives questions and investigates complaints and informally resolves disputes between those entities and CDER.

Published: May 15, 2026 | Category: FDA | Name: FDA Drugs

FDA approves atezolizumab for adjuvant treatment of muscle invasive bladder cancer in patients with molecular residual disease

On May 15, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc. and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) as adjuvant treatments for adults with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DN

Published: May 15, 2026 | Category: FDA | Name: FDA Drugs

Facilitating Collaboration Across CDER

C3TI facilitates collaboration across CDER through multi-channel engagement and a network of champions.

Published: May 14, 2026 | Category: FDA | Name: FDA Drugs

Rare Disease Regulatory Science Research

CDER's ARC Program supports external regulatory science projects through ARC-funded Broad Agency Announcement (BAA) research contracts. Learn more.

Published: May 14, 2026 | Category: FDA | Name: FDA Drugs

Compounding Quality Center of Excellence | Self-Guided Online Trainings

FDA Compounding Quality Center of Excellence’s is providing anytime, anywhere training resources to support outsourcing facilities and other stakeholders in their efforts to enhance the quality of compounded drugs. FDA offers self-guided online courses offering continuing education, webinar recordin

Published: May 14, 2026 | Category: FDA | Name: FDA Drugs

Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act

Compounders may only compound a drug that includes a bulk drug substance that complies with applicable USP or monograph, are components of an FDA approved drug, or appear on the FDA’s 503A bulks list.

Published: May 14, 2026 | Category: FDA | Name: FDA Drugs

Sun Pharmaceutical Industries, Inc. (Sun Pharma) Initiates Voluntary U.S. Nationwide Recall of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL Due To Potential Presence of Glass Particles

FOR IMMEDIATE RELEASE MUMBAI, INDIA and PRINCETON, NJ - May 13, 2026 – Sun Pharma is voluntarily recalling within the U.S. to the hospital/user level, one batch of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL, Lot # HAG2581B, Expiration 05/2027 (675 vials). The single batch of 675 vials i

Published: May 13, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: Forzinity

Published: May 13, 2026 | Category: FDA | Name: FDA Drugs

FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma

On May 13, 2026, the Food and Drug Administration granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines USA, Inc.), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase

Published: May 13, 2026 | Category: FDA | Name: FDA Drugs

FDA approves oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia

On May 13, 2026, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology, Inc.) with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude

Published: May 13, 2026 | Category: FDA | Name: FDA Drugs

Stimulant Use Disorders: Developing Drugs for Treatment

Published: May 13, 2026 | Category: FDA | Name: FDA Drugs

Development of Local Anesthetic Drug Products With Prolonged Duration of Effect

Published: May 13, 2026 | Category: FDA | Name: FDA Drugs

Development of Non-Opioid Analgesics for Acute Pain

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Development of Non-Opioid Analgesics for Acute Pain.” In connection with the SUPPORT for Patients and Communities Act (SUPPORT Act), the purpose of this guidance is to spur the

Published: May 13, 2026 | Category: FDA | Name: FDA Drugs

Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework

Guidance for Industry

Published: May 13, 2026 | Category: FDA | Name: FDA Drugs

Electronic Submission of Postmarket Safety Reports

This page provides human drug and biological product manufacturers, distributors, packers, and other parties subject to mandatory reporting requirements with the instructions on how to electronically submit postmarket Individual Case Safety Reports (ICSRs) to the FDA.

Published: May 12, 2026 | Category: FDA | Name: FDA Biologics

Smallpox

Smallpox is a serious, highly contagious, and sometimes fatal infectious disease. There is no specific treatment for smallpox disease, and the only prevention is vaccination. The name is derived from the Latin word for "spotted" and refers to the raised bumps that appear on the face and body of an i

Published: May 12, 2026 | Category: FDA | Name: FDA Biologics

Instructions for Completing Form FDA 3500

Published: May 12, 2026 | Category: FDA | Name: FDA Drugs

Pharmacal Issues Nationwide Recall of MG217 Multi-Symptom Treatment Cream & Skin Protectant Eczema Cream Due to Microbial Contamination

- May/8/2026- Jackson, WI, Pharmacal is recalling one lot of MG217 Multi-symptom Treatment Cream & Skin Protectant Eczema Cream, 6oz tube to the consumer level. The product has been found to be contaminated with Staphylococcus aureus.

Published: May 12, 2026 | Category: FDA | Name: FDA Drugs

Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre - 724911 - 04/29/2026

In Vivo Bioavailability-Bioequivalence Studies – Clinical

Published: May 12, 2026 | Category: FDA | Name: FDA Drugs

2026 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee

Published: May 12, 2026 | Category: FDA | Name: FDA Drugs

Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee

The Committee will discuss Sanofi US’ pending supplemental application seeking accelerated approval of TZIELD for a new indication: to delay the decline in endogenous insulin production in pediatric patients 8-17 years of age recently diagnosed with Stage 3 T1D.

Published: May 12, 2026 | Category: FDA | Name: FDA Drugs

DK Hardware Supply - 726865 - 04/03/2026

Unapproved New Animal Drug Products

Published: May 12, 2026 | Category: FDA | Name: FDA Drugs

IDO Pharm Co., Ltd. - 723449 - 05/04/2026

CGMP/OTC Finished Pharmaceuticals/Adulterated

Published: May 12, 2026 | Category: FDA | Name: FDA Drugs

Naveh Pharma LTD/Bigdam Inc. - 724669 - 05/04/2026

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

Published: May 12, 2026 | Category: FDA | Name: FDA Drugs

ProRx LLC - 723704 - 04/07/2026

Compounding Pharmacy/Adulterated Drug Products

Published: May 12, 2026 | Category: FDA | Name: FDA Drugs

Estar Technologies Ltd - 716831 - 04/22/2026

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

Published: May 12, 2026 | Category: FDA | Name: FDA Biologics

FDA Finalizes Food Chemical Safety Post-Market Assessment Program, Launches Reassessment of BHT, ADA

FDA continues to implement its bold food agenda, with two decisive actions focused on food chemical safety.

Published: May 12, 2026 | Category: FDA | Name: FDA Press Release

FDA Alerts Health Care Providers and Patients about Increased Risk of New Blood Cancers with Tazverik (tazemetostat) Use; Sponsor to Voluntarily Withdraw Product from Market

FDA is alerting patients and health care providers about the voluntary withdrawal of Tazverik (tazemetostat) from the market due to an increased rate of hematologic second primary malignancies. Read more.

Published: May 11, 2026 | Category: FDA | Name: FDA Drugs

Advancing Generic Drug Development: Bioequivalence Challenges for Patient-Centric Oral Formulations - 06/11/2026

This workshop is designed to facilitate discussions about the latest advancements and regulatory considerations in the evolving field of patient-centric (including pediatric) generic oral products, addressing product development and regulatory assessment challenges for these important medicines.

Published: May 11, 2026 | Category: FDA | Name: FDA Drugs

FDA Advances Drug Repurposing to Address Unmet Medical Needs

FDA announced it is soliciting input on efforts with respect to drug repurposing to help address unmet medical needs across a range of diseases and conditions.

Published: May 11, 2026 | Category: FDA | Name: FDA Press Release

Drug Repurposing

Drug repurposing refers to the identification of potential new uses – e.g., a new indication or a new population – of FDA-approved drugs, for which the new uses would be supported by safety and effectiveness data.

Published: May 11, 2026 | Category: FDA | Name: FDA Drugs

ABBE Laboratories, Inc. - 708309 - 08/06/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: May 11, 2026 | Category: FDA | Name: FDA Drugs

Quality CDMO, Inc. - 665961 - 05/01/2026

Unapproved New Drugs

Published: May 11, 2026 | Category: FDA | Name: FDA Drugs

Quality CDMO, Inc. - 665961 - 05/01/2026

Unapproved New Drugs

Published: May 11, 2026 | Category: FDA | Name: FDA Drugs

Quality CDMO, Inc. - 665961 - 09/11/2024

Unapproved New Drugs

Published: May 11, 2026 | Category: FDA | Name: FDA Drugs

Economic Assistance and Incentives for Drug Development

Small Business Assistance: Economic Assistance and Incentives for Drug Development

Published: May 8, 2026 | Category: FDA | Name: FDA Drugs

FDA approves zenocutuzumab-zbco for advanced, unresectable or metastatic cholangiocarcinoma

On May 8, 2026, the Food and Drug Administration approved zenocutuzumab-zbco (Bizengri, Partner Therapeutics, Inc.) for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. NRG1-fu

Published: May 8, 2026 | Category: FDA | Name: FDA Drugs

FDA Grants Seventh Approval under the National Priority Voucher Pilot Program

FDA issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion-positive cholangiocarcinoma, an ultra-rare, aggressive cancer that forms in the bile ducts.

Published: May 8, 2026 | Category: FDA | Name: FDA Press Release

Advertising & Promotional Labeling Questions and Answers

Published: May 8, 2026 | Category: FDA | Name: FDA Biologics

Communicating Benefit and Risk Information

FDA Drug Info Rounds pharmacists talk about the benefit risk balance, and how health care professionals may approach this topic with their patients.

Published: May 8, 2026 | Category: FDA | Name: FDA Drugs

Drug Promotion

FDA Drug Info Rounds pharmacists discuss the many elements surrounding the marketing and advertising of a prescription drug product.

Published: May 8, 2026 | Category: FDA | Name: FDA Drugs

FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics

The U.S. Food and Drug Administration today issued a final guidance for industry, Postapproval Pregnancy Safety Studies, with recommendations on different methodologies that can be used in the postapproval setting to study the safety of drugs and biological products when used during pregnancy.

Published: May 8, 2026 | Category: FDA | Name: FDA Press Release

Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention

Published: May 8, 2026 | Category: FDA | Name: FDA Drugs

Pulmonary Tuberculosis: Developing Drugs for Treatment

The purpose of this guidance is to assist sponsors in the clinical development of new antibacterial drugs for the treatment of pulmonary tuberculosis (TB).

Published: May 8, 2026 | Category: FDA | Name: FDA Drugs

Postapproval Pregnancy Safety Studies

This guidance provides sponsors and investigators with recommendations on how to design investigations to assess the outcomes in pregnant women exposed to drug and biological products regulated by FDA in the postapproval setting.

Published: May 8, 2026 | Category: FDA | Name: FDA Drugs

DUCORD

For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic & reconstitution in patients with disorders affecting hematopoietic system that are inherited,acquired,or result from myeloablative treatment.

Published: May 7, 2026 | Category: FDA | Name: FDA Biologics

Public Notification: Hard AF! contains hidden drug ingredients

Public Notification:Hard AF! contains hidden drug ingredients

Published: May 7, 2026 | Category: FDA | Name: FDA Drugs

High Blood Pressure–Understanding the Silent Killer

High blood pressure is known as the silent killer. There are often no symptoms until the heart, arteries, and other organs are already damaged.

Published: May 7, 2026 | Category: FDA | Name: FDA Drugs

Don’t Be Tempted to Use Expired Medicines

Published: May 7, 2026 | Category: FDA | Name: FDA Drugs

Anesthetic and Analgesic Drug Products Advisory Committee Charter

This is the Charter for the Anesthetic and Analgesic Drug Products Advisory Committee.

Published: May 7, 2026 | Category: FDA | Name: FDA Drugs

FDA initiates the Lysosomal Diseases Pre-Consortium at the Critical Path Institute

FDA’s Center for Drug Evaluation and Research (CDER) is pleased to announce its partnership with the Critical Path Institute (C-Path) to explore the feasibility of launching the Lysosomal Diseases Consortium, a public-private partnership among FDA, leading academic institutions, pharmaceutical indus

Published: May 7, 2026 | Category: FDA | Name: FDA Drugs

Submitting Continuous Glucose Monitoring Data in Clinical Trials

This document provides technical specifications for submitting continuous glucose monitoring (CGM) data in clinical trials to support a marketing application for a drug or biological product.

Published: May 7, 2026 | Category: FDA | Name: FDA Drugs

Vaccines and Related Biological Products Advisory Committee May 28, 2026 Meeting Announcement - 05/28/2026

On May 28, 2026, the Committee will meet in open session to discuss and make recommendations on the selection of the 2026-2027 Formula for COVID-19 vaccines for use in the United States.

Published: May 6, 2026 | Category: FDA | Name: FDA Biologics

What’s New in Clinical Trial Innovation

The Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI) disseminates a newsletter with information on new developments, opportunities, and initiatives in clinical trial innovation within the context of FDA.

Published: May 6, 2026 | Category: FDA | Name: FDA Drugs

Clinical Trials Day

Clinical Trials Day is celebrated on May 20, in recognition of what is often considered the start of the first randomized clinical trial.

Published: May 6, 2026 | Category: FDA | Name: FDA Drugs

FDA Expands AI Capabilities and Completes Data Platform Consolidation

FDA announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a significant upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.

Published: May 6, 2026 | Category: FDA | Name: FDA Press Release

FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight

FDA announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources more targeted and efficient.

Published: May 6, 2026 | Category: FDA | Name: FDA Press Release

Understanding Drug Recalls: What to Know and What to Do

Find out what to do if your medication is recalled. Learn how to identify recalled drugs by lot number, understand FDA recall classes, and get safety recommendations for patients and healthcare providers.

Published: May 6, 2026 | Category: FDA | Name: FDA Drugs

FDA approves selpercatinib for medullary thyroid cancer with a RET mutation

On September 27, 2024, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test.

Published: May 6, 2026 | Category: FDA | Name: FDA Drugs

Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application

This is the guidance of industry, Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application

Published: May 5, 2026 | Category: FDA | Name: FDA Biologics

Questions and Answers on Current Good Manufacturing Practice Regulations | Production and Process Controls

Questions and Answers on Current Good Manufacturing Practices—Production and Process Controls

Published: May 5, 2026 | Category: FDA | Name: FDA Drugs

FDA Expands Market Access, Authorizes New ENDS Products

FDA today authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application (PMTA) pathway.

Published: May 5, 2026 | Category: FDA | Name: FDA Press Release

RAPTURE Preworkout may be harmful due to hidden ingredient

The Food and Drug Administration is advising consumers not to purchase or use RAPTURE Preworkout, a dietary supplement promoted and sold to boost energy and increase performance on leaderformulas.com and possibly in some retail stores.

Published: May 5, 2026 | Category: FDA | Name: FDA Drugs

Ava Inc. - 721180 - 04/14/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: May 5, 2026 | Category: FDA | Name: FDA Drugs

CareFusion 213, LLC - 722729 - 04/30/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: May 5, 2026 | Category: FDA | Name: FDA Drugs

Active Cosmetics Manufacturing Inc. - 722408 - 04/22/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: May 5, 2026 | Category: FDA | Name: FDA Drugs

Intelligent Remedies, Inc. - 681941 - 01/23/2026

New Drug/Misbranded

Published: May 5, 2026 | Category: FDA | Name: FDA Drugs

Respilon Production S.R.O. - 719705 - 04/20/2026

CGMP/OTC/Finished Pharmaceuticals/Adulterated

Published: May 5, 2026 | Category: FDA | Name: FDA Drugs

ibeautistore.com - 726302 - 04/24/2026

Unapproved New Drug/Misbranded

Published: May 5, 2026 | Category: FDA | Name: FDA Drugs

Ray’s Vitamins - 726694 - 04/24/2026

Unapproved New Drug/Misbranded

Published: May 5, 2026 | Category: FDA | Name: FDA Drugs

BK261343- Biowy Multi-Chamber Freezing Bag Set

The Biowy Freezing Bag Set is intended for a single sequence of freezing, storage (in Liquid Nitrogen (-196°C)), and subsequent thawing (at +37°C) of hematopoietic progenitor cells.

Published: May 5, 2026 | Category: FDA | Name: FDA Biologics

ASCENIV

Indicated for the treatment of Primary Immunodeficiency Diseases (PIDD)

Published: May 4, 2026 | Category: FDA | Name: FDA Biologics

External Engagements with FDA for Artificial Intelligence in Drug Development

To discuss the use of AI in connection with a specific development program, sponsors may request an appropriate formal meeting. Learn more.

Published: May 1, 2026 | Category: FDA | Name: FDA Drugs

2026 Biological License Application Approvals

Listing of the 2026 Biological License Application Approvals

Published: May 1, 2026 | Category: FDA | Name: FDA Biologics

FDA works to protect consumers from potentially harmful OTC skin lightening products

Published: May 1, 2026 | Category: FDA | Name: FDA Drugs

FDA approves vepdegestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

Published: May 1, 2026 | Category: FDA | Name: FDA Drugs

FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug

FDA is announcing that it issued a “safe to proceed” letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol (EAP) for its experimental pancreatic cancer drug, daraxonrasib.

Published: May 1, 2026 | Category: FDA | Name: FDA Press Release

ROTARIX

Rotarix approval page indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9), for use in infants 6 weeks to 24 weeks of age.

Published: May 1, 2026 | Category: FDA | Name: FDA Biologics

Drug Trials Snapshot: TRYNGOLZA

TRYNGOLZA is a prescription medicine (an APOC-III-directed antisense oligonucleotide) that is used along with a low-fat diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).

Published: May 1, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshot: ALYFTREK

ALYFTREK is a medication for the treatment of cystic fibrosis (CF) in patients 6 years of age and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Published: May 1, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: DATROWAY

Published: May 1, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshot: ROMVIMZA

The FDA approved ROMVIMZA based on safety and efficacy evidence from one clinical trial (NCT05059262) of 123 patients with TGCT. Learn more about the trial.

Published: May 1, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: QFITLIA

QFITLIA is an antithrombin-directed small interfering ribonucleic acid indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors.

Published: May 1, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshot: VANRAFIA

VANRAFIA is an endothelin type A receptor antagonist that is indicated to reduce proteinuria in adults with primary immunoglobulin A (IgA) nephropathy at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g. Learn more about the clinical trials.

Published: May 1, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshot: AVMAPKI FAKZYNJA CO-PACK

AVMAPKI FAKZYNJA CO-PACK, a combination of avutometinib and defactinib, each kinase inhibitors, is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.

Published: May 1, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: BIMZELX

BIMZELX is an anti-interleukin (IL)-17A and IL-17F monoclonal antibody that is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Published: Apr 30, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshot: TALVEY

TALVEY is an antibody that is used to treat a form of blood cancer called multiple myeloma. It is used to treat adult patients whose cancer came back after, or did not respond to, at least four prior lines of therapy.

Published: Apr 30, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: OJJAARA

Drug Trials Snapshots: OJJARA is a drug used to treat a rare type of bone marrow disorder called myelofibrosis (MF) in adults with anemia.

Published: Apr 30, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: ELREXFIO

ELREXFIO is a drug used to treat a form of blood cancer called multiple myeloma.

Published: Apr 30, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: VEOPOZ

VEOPOZ is used to treat adults and pediatric patients 1 year of age and older with CD55 deficient protein-losing enteropathy (PLE), also known as CHAPLE disease.

Published: Apr 30, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: EXXUA

Published: Apr 30, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: POMBILITI

Published: Apr 30, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: ZILBRYSQ

Published: Apr 30, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia

The U.S. Food and Drug Administration today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults.

Published: Apr 30, 2026 | Category: FDA | Name: FDA Press Release

CDER Initiatives

Streamlining the Drug Development Process to Ensure Drugs are Safe and Effective

Published: Apr 30, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: AGAMREE

AGAMREE is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.

Published: Apr 30, 2026 | Category: FDA | Name: FDA Drugs

Pharmacy Compounding Advisory Committee Charter

The Pharmacy Compounding Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to compounding drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility.

Published: Apr 30, 2026 | Category: FDA | Name: FDA Drugs

FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List

FDA is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances.

Published: Apr 30, 2026 | Category: FDA | Name: FDA Press Release

Drug Trials Snapshots: LIVDELZI

LIVDELZI is a peroxisome proliferator-activated receptor (PPAR)-delta agonist that is used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshot: NIKTIMVO

NIKTIMVO is a drug used to treat adults and children who weigh at least 88.2 pounds (40 kg) with chronic graft-versus-host disease (GVHD) who have received at least two prior treatments (systemic therapy) and required additional treatment.

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots - LAZCLUZE

LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: EBGLYSS

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshot: MIPLYFFA

MIPLYFFA is a prescription medicine that is used in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease, Type C (NPC) in adults and children 2 years of age and older.

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products - 06/04/2026

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) is hosting its next virtual town hall on June 4, 2026. During this town hall, experts from OTP’s Office of Review Management & Regulatory Review (ORMRR) will answer questions regarding Biologic License Application (BLA) readiness, including how to...

Published: Apr 29, 2026 | Category: FDA | Name: FDA Biologics

Drug Trials Snapshot: COBENFY

COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist, and is used for the treatment of schizophrenia in adults.

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: AQNEURSA

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: FLYRCADO

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drugs Trials Snapshot: ITOVEBI

ITOVEBI is a medicine approved for use along with palbociclib and fulvestrant to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer that also has a change (known as a mutation) in a gene called PIK3CA.

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots - HYMPAVZI

HYMPAVZI is a drug used to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or hemophilia B.

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: VYLOY

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: ORLYNVAH

Drug Trials Snapshots: ORLYNVAH

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: REVUFORJ

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: ZIIHERA

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshot: ATTRUBY

ATTRUBY is a transthyretin stabilizer that is indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular (CV) death and CV-related hospitalization.

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: RAPIBLYK

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

GAMUNEX-C

For use in primary humoral immunodeficiency, idiopathic thrombocytopenic purpura and chronic inflammatory demyelinating polyneuropathy.

Published: Apr 29, 2026 | Category: FDA | Name: FDA Biologics

Drug Trials Snapshots: VORANIGO

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: LEQSELVI

LEQSELVI is a Janus kinase (JAK) inhibitor that is indicated for the treatment of adults with severe alopecia areata (AA).

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: KISUNLA

Drug Trials Snapshots: KISUNLA is an amyloid beta-directed antibody used to treat people with Alzheimer’s disease. Alzheimer’s disease is a common degenerative disease of the brain that starts with mild thinking, judging, and memory problems and progresses to dementia and death.

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: PIASKY

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: SOFDRA

SOFDRA is an anticholinergic antiperspirant approved for primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: IQIRVO

Drug Trials Snapshots: IQIRVO is a agonist used to treat primary biliary cholangitis (PBC). It's prescribed with ursodeoxycholic acid (UDCA) for adults who don't respond well to UDCA alone, or as a standalone treatment for those who can't tolerate UDCA.

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: RYTELO

RYTELO is a prescription medicine used to treat a condition called low- to intermediate-1 risk myelodysplastic syndromes (MDS) in adults with anemia.

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: XOLREMDI

XOLREMDI is a prescription drug that increases the number of white blood cells released from the bone marrow into the blood. XOLREMDI is indicated for the treatment of adults and adolescents over the age of 12 years with WHIM (Warts, Hypogammaglobulinemia, Infection, and Myelokathexis) syndrome.

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: OJEMDA

Drug Trials Snapshots: OJEMDA is a kinase inhibitor that is used to treat patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: ANKTIVA

ANKTIVA is a drug to activate the immune system used together with another drug called Bacillus Calmette-Guerin (BCG) to treat a subtype of non-muscle invasive bladder cancer (NMIBC), called carcinoma in situ (CIS).

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshot: LUMISIGHT

LUMISIGHT is a drug used for fluorescence imaging in adults with breast cancer to help detect cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: ZEVTERA

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: RYZNEUTA

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: DEFENCATH

DEFENCATH is a catheter lock solution (CLS) to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC).

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: AUGTYRO

AUGTYRO is a drug used to treat adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: OGSIVEO

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshot: FABHLATA

FABHALTA is a prescription drug that is a complement factor B inhibitor, indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).

Published: Apr 29, 2026 | Category: FDA | Name: FDA Drugs

FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.

FDA announces results from the largest and most rigorous examination ever conducted focused on chemical contaminants in infant formula available on the U.S. market.

Published: Apr 29, 2026 | Category: FDA | Name: FDA Press Release

Drug Trials Snapshots: KOMZIFTI

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: REDEMPLO

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: LEROCHOL

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: IBTROZI

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: ANDEMBRY

ANDEMBRY is a medication used to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older.

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: ZEGFROVY

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshot: LYNOZYFIC

LYNOZYFIC is a bispecific antibody used to treat a type of cancer called multiple myeloma. Learn more about the drug trials.

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: EKTERLY

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: ANZUPGO

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: SEPHIENCE

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: VIZZ

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: MODEYSO

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: HERNEXEOS

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: BRINSUPRI

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: DAWNZERA

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: WAYRILZ

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: INLURIYO

INLURIYO is a drug for the treatment of adults with a specific form of advanced breast cancer. The cancer had to progress (grew or got worse) during or after previous treatment with endocrine therapy.

Published: Apr 28, 2026 | Category: FDA | Name: FDA Drugs

FDA Announces Major Steps to Implement Real-Time Clinical Trials

The U.S. Food and Drug Administration today announced two major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCT).

Published: Apr 28, 2026 | Category: FDA | Name: FDA Press Release

CDER proposes to withdraw approval of TAVNEOS

Published: Apr 27, 2026 | Category: FDA | Name: FDA Drugs

April 30, 2026: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 04/30/2026

April 30, 2026: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

Published: Apr 27, 2026 | Category: FDA | Name: FDA Drugs

SBIA Resources in Chinese 中文信息

Small Business Business and Industry Assistance resources in Chinese

Published: Apr 27, 2026 | Category: FDA | Name: FDA Drugs

Video and Transcript: FDA|CDER’s Small Business and Industry Assistance (SBIA)

The journey to develop and market a human drug can be long, complex, and filled with regulations. But, FDA’s CDER Small Business and Industry Assistance – or SBIA- is here to help!

Published: Apr 27, 2026 | Category: FDA | Name: FDA Drugs

MACI (autologous cultured chondrocytes on porcine collagen membrane)

MACI (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults.

Published: Apr 27, 2026 | Category: FDA | Name: FDA Biologics

Withdrawn | Cancer Accelerated Approvals

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved.

Published: Apr 27, 2026 | Category: FDA | Name: FDA Drugs

AFSTYLA

AFSTYLA, Antihemophilic Factor (Recombinant), Single Chain, is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for: • On-demand treatment and control of bleeding episodes, • Routine prophylaxis to reduce the frequency of ble

Published: Apr 27, 2026 | Category: FDA | Name: FDA Biologics

Vaccines and Related Biological Products Advisory Committee Meeting May 28, 2026 Announcement - 05/28/2026

On May 28, 2026, the Committee will meet in open session to discuss and make recommendations on the selection of the 2026-2027 Formula for COVID-19 vaccines for use in the United States.

Published: Apr 27, 2026 | Category: FDA | Name: FDA Biologics

FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order

On April 18, President Trump issued an Executive Order directing the U.S. Department of Health and Human Services (HHS) to accelerate access to treatments for patients with serious mental illness, including devastating, complex, and treatment-resistant conditions.

Published: Apr 24, 2026 | Category: FDA | Name: FDA Press Release

List of Active Radioactive Drug Research Committee (RDRC) Sites

List of Active RDRC Sites

Published: Apr 23, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program

The U.S. Food and Drug Administration today approved Otarmeni (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy.

Published: Apr 23, 2026 | Category: FDA | Name: FDA Press Release

Drug Trials Snapshot: NUZOLVENCE

Published: Apr 23, 2026 | Category: FDA | Name: FDA Drugs

CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices

CMS and FDA announce the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new pathway designed to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare.

Published: Apr 23, 2026 | Category: FDA | Name: FDA Press Release

FDA notification regarding dehydrated alcohol

Published: Apr 22, 2026 | Category: FDA | Name: FDA Drugs

GDUFA III Drug Master File (DMF) Review Enhancements

Effective communication among ANDA applicants, DMF holders, and FDA is essential for reducing the likelihood of potential problems that could delay approvals.

Published: Apr 22, 2026 | Category: FDA | Name: FDA Drugs

FDA PreCheck Pilot Program Structure

Detailed information for the FDA Manufacturing PreCheck Pilot Program

Published: Apr 22, 2026 | Category: FDA | Name: FDA Drugs

2024 Recalls - Health Fraud

Published: Apr 22, 2026 | Category: FDA | Name: FDA Drugs

Public Notification: Slimina contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Slimina, a product promoted and sold for weight loss on various websites, including www.effectivehealthyproducts.com, and possibly in some retail stores.

Published: Apr 22, 2026 | Category: FDA | Name: FDA Drugs

Public Notification: The Silver Bullet contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use The Silver Bullet, a product promoted for sexual enhancement and sold on various websites, including www.ebay.com, and possibly in some retail stores.

Published: Apr 22, 2026 | Category: FDA | Name: FDA Drugs

Drug Safety-related Labeling Changes (SrLC) Database Overview: Updates to Safety Information in FDA-Approved Prescription Drug Labeling

As of September 1, 2016, the safety labeling changes (SLC) program will be managed by the Center for Drug Evaluation and Research’s (CDER’s) Office of Communications (OCOMM).

Published: Apr 22, 2026 | Category: FDA | Name: FDA Drugs

CDER Contact Information

Contact Information

Published: Apr 21, 2026 | Category: FDA | Name: FDA Drugs

ERVEBO

ERVEBO® is a vaccine indicated for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older.

Published: Apr 21, 2026 | Category: FDA | Name: FDA Biologics

FDA Announces FDA PreCheck Implementation Roadmap

FDA announces that it will begin accepting applications on Feb. 1, 2026 for the FDA PreCheck Pilot Program, a program to strengthen the domestic pharmaceutical supply chain.

Published: Apr 21, 2026 | Category: FDA | Name: FDA Drugs

FDA Public Meeting on Increasing Access to Nonprescription Drugs - 04/23/2026

FDA Public Meeting on Increasing Access to Nonprescription Drugs

Published: Apr 21, 2026 | Category: FDA | Name: FDA Drugs

Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval - 05/09/2024

Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval

Published: Apr 21, 2026 | Category: FDA | Name: FDA Drugs

New Life Pharma LLC - 725661 - 04/14/2026

CGMP/Adulterated and Unapproved New Drug/Misbranded

Published: Apr 21, 2026 | Category: FDA | Name: FDA Drugs

SaNOtize - 727784 - 04/17/2026

Unapproved New Drugs

Published: Apr 21, 2026 | Category: FDA | Name: FDA Drugs

Pro Numb Tattoo Numbing Spray, LLC - 722589 - 04/14/2026

CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

Published: Apr 21, 2026 | Category: FDA | Name: FDA Drugs

Par Health USA, LLC & Endo USA, Inc. - 722121 - 04/15/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Apr 21, 2026 | Category: FDA | Name: FDA Drugs

Xiamen Kang Zhongyuan Biotechnology Co., Ltd. - 719320 - 03/23/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Apr 21, 2026 | Category: FDA | Name: FDA Drugs

RC Outsourcing, LLC - 722877 - 03/20/2026

Compounding Pharmacy/Adulterated Drug Products

Published: Apr 21, 2026 | Category: FDA | Name: FDA Drugs

UCSF Radiopharmaceutical Facility - 719568 - 04/13/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Apr 21, 2026 | Category: FDA | Name: FDA Drugs

Thrive Health and Wellness, LLC dba Thrive Health Solutions - 714891 - 02/09/2026

Compounding Pharmacy/Adulterated Drug Products

Published: Apr 21, 2026 | Category: FDA | Name: FDA Drugs

Apollo Care, LLC - 715955 - 02/02/2026

Compounding Pharmacy/Adulterated Drug Products

Published: Apr 21, 2026 | Category: FDA | Name: FDA Drugs

FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development

Since publishing roadmap last April, agency has successfully launched several key initiatives to replace animal testing with better alternatives

Published: Apr 20, 2026 | Category: FDA | Name: FDA Press Release

New Approach Methodologies (NAMs)

The FDA is leading a transformative shift in drug safety evaluation—reducing, replacing or refining animal testing with advanced, human-relevant methods that better predict how medicines work in people.

Published: Apr 20, 2026 | Category: FDA | Name: FDA Drugs

Regulatory Submissions in Electronic Format for CBER-Regulated Products

To facilitate FDA’s transition to a fully automated electronic submission and review process, many of the FDA electronic submission standards are now mandatory

Published: Apr 17, 2026 | Category: FDA | Name: FDA Biologics

Establishing Impurity Specifications for Antibiotics

Published: Apr 17, 2026 | Category: FDA | Name: FDA Drugs

MD Pharmaceutical Supply, LLC - 637815 - 04/13/2026

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Apr 17, 2026 | Category: FDA | Name: FDA Drugs

MD Pharmaceutical Supply, LLC - 637815 - 11/22/2022

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Apr 17, 2026 | Category: FDA | Name: FDA Drugs

First FDA-Approved Treatment for Patients with Focal Segmental Glomerulosclerosis—A Rare Kidney Condition

The U.S. Food and Drug Administration on Monday approved a new indication for Filspari (sparsentan) tablets for reducing proteinuria (abnormal levels of protein in the urine) in patients aged eight years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.

Published: Apr 16, 2026 | Category: FDA | Name: FDA Drugs

FDA Scientists Working in Satellite Laboratories Across U.S. Help Prevent Harmful Drugs from Reaching Americans

Satellite laboratories stationed inside high-volume international mail facilities at airports in Chicago, New York, Los Angeles, Miami—and now Honolulu—are one of the U.S. Food and Drug Administration’s numerous weapons in combating counterfeit and other potentially harmful drugs.

Published: Apr 16, 2026 | Category: FDA | Name: FDA Drugs

Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments - 06/23/2026

FDA's annual public meeting and opportunity for public comment on “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments” will be held on June 23, 2026

Published: Apr 16, 2026 | Category: FDA | Name: FDA Drugs

FDA Webinar on the RCT-DUPLICATE Initiative: Emulating Randomized Clinical Trials with Non-Randomized Real-World Data Studies - 04/29/2026

On Wednesday, April 29, 2026, the FDA is hosting a free public webinar to provide updates on RCT-DUPLICATE, one of FDA’s demonstration projects addressing key methodological challenges in studies using real-world data (RWD).   

Published: Apr 16, 2026 | Category: FDA | Name: FDA Drugs

FDA Takes Step Forward on Testosterone Therapy for Men

FDA is taking an initial step to advance treatment options for men’s health by encouraging sponsors of approved testosterone replacement therapy products to contact FDA for information if they are interested in pursuing a potential new indication for low libido in men with idiopathic hypogonadism.

Published: Apr 16, 2026 | Category: FDA | Name: FDA Press Release

7 Things to Know About the Nonprescription Drug Product with an Additional Condition for Nonprescription Use Final Rule

Published: Apr 16, 2026 | Category: FDA | Name: FDA Drugs

ybycmeds - 715878 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 16, 2026 | Category: FDA | Name: FDA Drugs

Vitals RX - 715868 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 16, 2026 | Category: FDA | Name: FDA Drugs

Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards - 04/04/2023

The purpose of these public meetings is to provide the pharmaceutical industry and other interested parties with information on the plans, progress, and technical specifications to upgrade electronic submission standards for the premarket and postmarket safety surveillance programs managed by CDER and CBER

Published: Apr 16, 2026 | Category: FDA | Name: FDA Drugs

Tuyo Health, Inc. dba Tuyo Health - 716502 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 16, 2026 | Category: FDA | Name: FDA Drugs

TRYM Health, Inc. dba TRYM Health - 716699 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 16, 2026 | Category: FDA | Name: FDA Drugs

Try Nova - 716695 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 16, 2026 | Category: FDA | Name: FDA Drugs

The HCG Institute - 716512 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 16, 2026 | Category: FDA | Name: FDA Drugs

Sprout Health Partners LLC dba Sprout Health - 715879 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 16, 2026 | Category: FDA | Name: FDA Drugs

Slendid - 716700 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 16, 2026 | Category: FDA | Name: FDA Drugs

Over-the-Counter (OTC) Related Federal Register Notices, Ingredient References, and other Regulatory Information

Published: Apr 15, 2026 | Category: FDA | Name: FDA Drugs

Information about Nitrosamine Impurities in Medications

General questions and answers and general information for patients, health care providers and industry

Published: Apr 15, 2026 | Category: FDA | Name: FDA Drugs

The Bad Ad Program

FDA's Bad Ad program is an outreach program designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.

Published: Apr 15, 2026 | Category: FDA | Name: FDA Drugs

FDA Updates and Press Announcements on Nitrosamine in Varenicline (Chantix)

FDA Updates and Press Announcements on Nitrosamine in in Varenicline (Chantix)

Published: Apr 15, 2026 | Category: FDA | Name: FDA Drugs

FDA Updates and Press Announcements on Nitrosamines in Rifampin and Rifapentine

Published: Apr 15, 2026 | Category: FDA | Name: FDA Drugs

FDA Responses to Action Items Identified in 2022 Inter-governmental Working Meeting on Drug Compounding

Published: Apr 15, 2026 | Category: FDA | Name: FDA Drugs

Compounding Quality Center of Excellence | Recorded Webinars

The FDA Compounding Quality Center of Excellence offers free recorded webinars to provide information about current good manufacturing practice standards and the agency’s inspectional processes.

Published: Apr 15, 2026 | Category: FDA | Name: FDA Drugs

Compounding Inspections and Oversight Frequently Asked Questions

Find answers to frequently asked questions regarding FDA’s inspections of compounding facilities. Including: When does FDA inspect a compounder? What does FDA do when a compounder refuses to be inspected? How do I know if a compounder has corrected violations outlined in a warning letter?

Published: Apr 15, 2026 | Category: FDA | Name: FDA Drugs

Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

Significant changes from the 2017 version include additional recommendations related to IRB review; informed consent, including a template; and new requirements established by the Cures Act and FDARA related to sponsors making their expanded access policies public and readily available.

Published: Apr 15, 2026 | Category: FDA | Name: FDA Drugs

OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice - 06/13/2024

OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice

Published: Apr 15, 2026 | Category: FDA | Name: FDA Drugs

An FDA Self-Audit of Continuous Manufacturing for Drug Products | Audio Transcript

Preparation is key when managing drug product recalls. It is critical for firms to be “recall ready” so that they can act quickly and effectively to protect the public from violative products on the market.

Published: Apr 15, 2026 | Category: FDA | Name: FDA Drugs

2026 Meeting Materials, Pharmacy Compounding Advisory Committee

Published: Apr 15, 2026 | Category: FDA | Name: FDA Drugs

July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee - 07/23/2026

On July 23-24, 2026, the Committee will discuss bulk drug substances being considered for inclusion on the 503A Bulks List.

Published: Apr 15, 2026 | Category: FDA | Name: FDA Drugs

Labeling Information | Drug Products

For more information on labeling, including Physician Labeling Rule (PLR) requirements, guidances, presentations, sample templates and format tools, and established pharmacologic class (EPC) resources, please see the PLR Requirements for Prescribing Information web page

Published: Apr 15, 2026 | Category: FDA | Name: FDA Drugs

Drug Supply Chain Security Act Law and Policies

Since the Drug Supply Chain Security Act (DSCSA) was enacted in 2013, FDA has issued the following guidance and policy documents

Published: Apr 15, 2026 | Category: FDA | Name: FDA Drugs

Hello Cake, Inc. dba Hello Cake - 716484 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 14, 2026 | Category: FDA | Name: FDA Drugs

iVisitDoc, Inc. dba iVisitDoc - 716826 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 14, 2026 | Category: FDA | Name: FDA Drugs

EA WORKS Limited Liability Company dba Trust Labs - 715798 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 14, 2026 | Category: FDA | Name: FDA Drugs

The ABCs of Product Specific Guidances

Product-specific guidances (or PSGs for short) describe the Agency's current thinking on the evidence needed to demonstrate that a generic drug is therapeutically equivalent to the corresponding reference listed drug (RLD) product.

Published: Apr 14, 2026 | Category: FDA | Name: FDA Drugs

Invigorate Med Spa - 715872 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 14, 2026 | Category: FDA | Name: FDA Drugs

Intimate Rose - 716458 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 14, 2026 | Category: FDA | Name: FDA Drugs

inspire.clinic - 715799 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 14, 2026 | Category: FDA | Name: FDA Drugs

Hims & Hers Health, Inc. dba Hims - 716567 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 14, 2026 | Category: FDA | Name: FDA Drugs

Healthy Male - 716506 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 14, 2026 | Category: FDA | Name: FDA Drugs

Healthy Living Clinic - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 14, 2026 | Category: FDA | Name: FDA Drugs

Healthon Inc. dba Healthon - 719809 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 14, 2026 | Category: FDA | Name: FDA Drugs

HealBerry - 719809 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 14, 2026 | Category: FDA | Name: FDA Drugs

GLP-1 Solution - 715883 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 14, 2026 | Category: FDA | Name: FDA Drugs

Get.Fit.Medical, LLC dba Get.Fit.Medical - 715801 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 14, 2026 | Category: FDA | Name: FDA Drugs

GenLabMeds - 713650 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 14, 2026 | Category: FDA | Name: FDA Drugs

FitRX, LLC dba Zealthy - 716501 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

Published: Apr 14, 2026 | Category: FDA | Name: FDA Drugs

FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development

The U.S. Food and Drug Administration today issued a draft guidance for sponsors seeking approval of human gene therapy products involving genome editing technologies.

Published: Apr 14, 2026 | Category: FDA | Name: FDA Press Release

Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing

This is the draft guidance for industry, Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing

Published: Apr 14, 2026 | Category: FDA | Name: FDA Biologics

From Our Perspective: The Orange Book at 40: A Valued FDA Resource Continually Enhanced by User Input

Published: Apr 13, 2026 | Category: FDA | Name: FDA Drugs

CBER 2026 Orphan Approvals (new BLAs)

Published: Apr 13, 2026 | Category: FDA | Name: FDA Biologics

FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds

Published: Apr 13, 2026 | Category: FDA | Name: FDA Drugs

Review and Approval

All FDA-approved biological products (biologics), including biosimilars and interchangeable biosimilars, undergo a rigorous evaluation so that health care providers and patients can be confident of the safety, effectiveness, and quality of these products.

Published: Apr 13, 2026 | Category: FDA | Name: FDA Drugs

July - September 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Published: Apr 13, 2026 | Category: FDA | Name: FDA Drugs

April - June 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Published: Apr 13, 2026 | Category: FDA | Name: FDA Drugs

October - December 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Signals of Serious Risks (FAERS)

Published: Apr 13, 2026 | Category: FDA | Name: FDA Drugs

July - September 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Signals of Serious Risks (FAERS)

Published: Apr 13, 2026 | Category: FDA | Name: FDA Drugs

April - June 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Signals of Serious Risks (FAERS)

Published: Apr 13, 2026 | Category: FDA | Name: FDA Drugs

January - March 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Signals of Serious Risks (FAERS)

Published: Apr 13, 2026 | Category: FDA | Name: FDA Drugs

July – September 2015 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Products and potential signals of serious risks/new safety information that were identified for these products

Published: Apr 13, 2026 | Category: FDA | Name: FDA Drugs

FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results

The U.S. Food and Drug Administration has reminded more than 2,200 medical product companies and researchers of the requirements to submit certain clinical trial results information to ClinicalTrials.gov.

Published: Apr 13, 2026 | Category: FDA | Name: FDA Press Release

Health Canada and United States Food and Drug Administration Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - 11/04/2019

Health Canada and United States Food and Drug Administration Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Published: Apr 13, 2026 | Category: FDA | Name: FDA Drugs

PreCheck Pilot Program Structure

Detailed information for the FDA Manufacturing PreCheck Pilot Program

Published: Apr 10, 2026 | Category: FDA | Name: FDA Drugs

Bioanalytical Method Validation for Biomarkers

This guidance helps sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and NDA and BLA supplements.

Published: Apr 10, 2026 | Category: FDA | Name: FDA Drugs

FDA/Center for Research on Complex Generics (CRCG) Workshop on Bioequivalence Innovations for Generic Oral Products: Biowaivers, Bridging, and Development for Oncology and Discontinued Products - 05/05/2026

Gain valuable insights into the intricacies of developing generic oral products across diverse areas, including oncology drugs, unavailable reference listed drugs or reference standards, and drug products that are reformulated to mitigate nitrosamine risks.

Published: Apr 10, 2026 | Category: FDA | Name: FDA Drugs

Recalls of Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan

Get current information about recalls of blood pressure medications

Published: Apr 9, 2026 | Category: FDA | Name: FDA Drugs

OCMO Guidance Agenda

The Office of the Chief Medical Officer (OCMO) is sharing lists of planned guidance documents for public review and input, including guidance documents we intend to publish in calendar year 2025, and guidance documents we are developing and intend to publish in calendar years 2026-2027.

Published: Apr 9, 2026 | Category: FDA | Name: FDA Drugs

Compounding Research

FDA is engaged with the following institutions to conduct research to help inform the public and the agency’s policies regarding compounded drugs

Published: Apr 9, 2026 | Category: FDA | Name: FDA Drugs

Makena (hydroxyprogesterone caproate injection) Information

FDA CDER proposed that Makena (hydroxyprogesterone caproate injection) be withdrawn from the market because the required postmarket study failed to verify clinical benefit and we have concluded that the available evidence does not show Makena is effective for its approved use

Published: Apr 9, 2026 | Category: FDA | Name: FDA Drugs

Pure Indulgence Aesthetics - 723267 - 04/01/2026

Drug Supply Chain Security Act (DSCSA) Violations

Published: Apr 9, 2026 | Category: FDA | Name: FDA Drugs

Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination

Santa Fe Springs, California – April 07, 2026 – Blaine Labs, Inc. is voluntarily recalling three (3) lot numbers of Wound Care Gel products, 1 oz. & 3 oz. (0.1% Benzalkonium Chloride) to the consumer level due to microbial contamination.

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA approves safety labeling changes for opioid pain medicines

Today, FDA is announcing final approval and immediately effective implementation of required labeling updates to continue efforts to address the evolving opioid crisis, and to urge health care professionals to take a more patient-centered approach when prescribing opioid analgesic products.

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain

FDA continues to investigate counterfeit Ozempic (semaglutide) injection 1 milligram (mg) in the legitimate U.S. drug supply chain and has seized thousands of units of the product. The agency advises wholesalers, retail pharmacies, health care practitioners and patients to check the pro

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA's ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience

FDA's Center for Drug Evaluation and Research (CDER) recently accepted a new submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. This submission is the first artificial intelligence-based and digital health technology-based project and the first pro

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA revises letter of authorization for the emergency use authorization for Paxlovid

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA issues guidance regarding drug development for early Alzheimer’s disease

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA Announces New Quality Oversight Webpage

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

CDER Establishes New Quantitative Medicine Center of Excellence

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation

Questions and Answers on Mifeprex

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA updates guidance on interchangeability

FDA issued a draft guidance for industry “Considerations for Demonstrating Interchangeability with a Reference Product: Update.” Learn more.

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA's ISTAND Pilot Program accepts a submission of first organ-on-a-chip technology designed to predict human drug-induced liver injury (DILI)

FDA accepts first letter of intent (LOI) into the ISTAND Pilot Program for an organ-on-a-chip technology, a type of micro-physiological system (MPS), to study drug-induced liver injury (DILI) for certain drug candidates.

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

CDER soliciting comments regarding clinical trial innovation

Today, CDER announced that the center is soliciting public comments to understand the state of innovation in clinical trial design and conduct. CDER is gathering information from internal and external stakeholders on the barriers and facilitators to incorporating innovative clinical trial approache

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize

The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. Tirzepatide injection has been in shortage since 2022 due to increased demand.

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA issues guidance to help increase supply of ibuprofen oral suspension products in hospitals and health systems

FDA is issuing an immediately-in-effect guidance on compounding certain ibuprofen products in an effort to improve the supply of pediatric ibuprofen amid record high demand.

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA launches Lupus Treatment Consortium in partnership with the Lupus Research Alliance

FDA’s Center for Drug Evaluation and Research has partnered with the Lupus Research Alliance (LRA) to launch the Lupus Accelerating Breakthroughs Consortium (Lupus ABC), a first-of-its-kind public-private partnership focused on addressing challenges impacting lupus clinical trial success.

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA authorizes Gohibic (vilobelimab) injection for the treatment of COVID-19

FDA authorizes Gohibic (vilobelimab) injection

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA issues final guidance on adjusting for covariates in randomized clinical trials

This final guidance describes the agency’s current recommendations regarding adjusting for covariates in the statistical analysis of randomized clinical trials in drug and biological product development programs.

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

DSCSA compliance policies establish 1-year stabilization period for implementing electronic systems

Drug Supply Chain Security Act compliance policy guidances establish 1-year stabilization period for implementation of electronic interoperable systems

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA clarifies results of recent advisory committee meeting on oral phenylephrine

FDA held a Non-prescription Drug Advisory Committee meeting Sept. 11-12, 2023, to discuss the effectiveness of oral phenylephrine as an active ingredient in over-the-counter (OTC) cough and cold products.

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA issues draft guidance regarding confirmatory evidence of clinical trials

FDA issues draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence.

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA Announces New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing

FDA is announcing a new pilot prioritization program for the review of abbreviated new drug applications (ANDAs) that aims to spur and reward investment in U.S. drug manufacturing and research and development and strengthen the domestic pharmaceutical supply chain.

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA accepts proposal for reasonably likely surrogate endpoint for ‘MASH’ all-cause mortality or liver-related events

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

Limited number of voluntary recalls initiated after FDA testing of acne products for benzene; findings show a small number of products with elevated levels of benzene contamination

Voluntary recalls of acne products after FDA testing finds small number of proudcts with elevated levels of benzene

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA issues class-wide labeling changes for testosterone products

FDA issues labeling changes for all testosterone products following conclusion of ambulatory blood pressure monitoring studies and TRAVERSE trial,

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA qualifies drug development tool to facilitate clinical trial research on alcohol use disorder

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA recommends changes to labeling for transmucosal buprenorphine products indicated to treat opioid use disorder

Updated labeling would clarify maximum daily dosages for products indicated to treat opioid use disorder.

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA issues final rule to broaden types of nonprescription drugs available to consumers

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

CDER establishes new Center for Real-World Evidence Innovation

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) announced the new CDER Center for Real-World Evidence Innovation (CCRI) which aims to coordinate, advance, and promote the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA approves REMS modification, advancing new drug disposal option

FDA approves risk evaluation and mitigation strategy (REMS) modification, advancing new drug disposal option for opioid analgesics.

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA issues agency-initiated proposed order regarding OTC monograph drugs containing acetaminophen

Today, FDA issued a proposed administrative order, to address a safety issue related to over-the-counter (OTC) monograph drug products containing acetaminophen.

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

FDA establishes CDER Center for Clinical Trial Innovation (C3TI)

FDA establishes CDER Center for Clinical Trial Innovation (C3TI), which will promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally.

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

October - December 2019 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Signals of Serious Risks (FAERS)

Published: Apr 8, 2026 | Category: FDA | Name: FDA Drugs

Yeicob Ácido Hialurónico may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Yeicob Ácido Hialurónico, a product promoted and sold for joint pain on various websites, including raysvitamins.com, and possibly in some retail stores.

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

KUKA FLEX CBD may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use KUKA FLEX CBD, a product promoted and sold for joint pain on various websites, including ebay.com, and possibly in some retail stores.

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

Epinephrine Auto-Injector Devices by Amneal and Impax: CDER Alert - FDA Alerts Patients and Health Care Professionals About Device Malfunction

FDA is alerting the public to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present.

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

DINA Acido Hialurónico may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use DINA Acido Hialurónico, a product promoted and sold for joint pain on various websites, including ebay.com, and possibly in some retail stores.

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

RM Joe may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use RM Joe, a product promoted and sold for joint pain on various websites, including naturistamexicanstore.com, and possibly in some retail stores.

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

Curcuflex may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Curcuflex, a product promoted and sold for joint pain on various websites, including ebay.com, and possibly in some retail stores.

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems

Listen to an audio podcast of the April 24, 2020 FDA Drug Safety Communication: FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems. Close supervision is recommended

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

FDA warns that vapors from alcohol-based hand sanitizers can have side effects

Listen to an audio podcast of the June 16, 2021 Drug Safety Communication "FDA warns that vapors from alcohol-based hand sanitizers can cause symptoms such as headache, nausea, and dizziness after applying to the skin"

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

FDA requests withdrawal of bacitracin for injection from market

FDA requested that all current manufacturers of bacitracin for injection voluntarily withdraw their product from the market. FDA believes that the potential problems associated with bacitracin for injection are sufficiently serious to remove the drug from the market.

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)

Listen to FDA Drug Safety Podcast on Drug Safety Communication titled "FDA warns about serious Problems with high doses of the allergy medicine diphenhydramine (Bendaryl).

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves First Generic Dapagliflozin Tablets

The U.S. Food and Drug Administration approved the first generics of FARXIGA (dapagliflozin) tablets to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus.

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

Herbal Vitality, Inc. - 640206 - 03/07/2023

Unapproved New Drugs/Misbranded

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

Optimizing Pregnancy Registries Public Workshop - 05/07/2026

This public workshop will discuss challenges in designing and implementing pregnancy registries and consider innovative approaches to improve the design and conduct of pregnancy registries to inform the safety of drug and biological products during pregnancy.

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

Profilnine SD - Factor IX Complex

Product approval information is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B.

Published: Apr 7, 2026 | Category: FDA | Name: FDA Biologics

La FDA retira la aprobación del medicamento para linfoma Ukoniq (umbralisib) debido a preocupaciones de seguridad

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)

A safety clinical trial shows a possible increased risk of cancer with the weight-loss drug Belviq, Belviq XR. Consider the benefits and risks when deciding to prescribe or continue patients on the drug.

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems

FDA warns that untreated constipation caused by schizophrenia drug clozapine (Clozaril) can get worse and lead to serious bowel problems that might require hospitalization or even cause death

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market

FDA has requested that the weight-loss drug Belviq, Belviq XR be withdrawn from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. Stop taking the drug and talk to your health care professional if you have questions.

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis

FDA requires a Boxed Warning about serious mental health side effects for the asthma & allergy drug Singulair (montelukast). Only take montelukast for hay fever if other medicines do not work or cannot be tolerated.

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

Remarks by FDA Chief Scientist Denise Hinton to the Professional Services Council FedHealth Conference - 03/11/2021

Remarks by FDA Chief Scientist Denise Hinton to the Professional Services Council FedHealth Conference, March 11, 2020

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

WAP Sensual Enhancement may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use WAP Sensual Enhancement, a product promoted and sold for sexual enhancement on various websites, including ebay.com, and possibly in some retail stores.

Published: Apr 7, 2026 | Category: FDA | Name: FDA Drugs

FDA Public Meeting: FDA-Led Patient-Focused Drug Development Meeting for Nonhealing Chronic Wounds - 08/25/2026

On August 25, 2026, the U.S. Food and Drug Administration (FDA) is hosting a hybrid public meeting on Patient-Focused Drug Development for Nonhealing Chronic Wounds.

Published: Apr 6, 2026 | Category: FDA | Name: FDA Drugs

OPDP Regulatory Information

Published: Apr 6, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Info Rounds Video

A new series of training videos for practicing clinical and community pharmacists

Published: Apr 6, 2026 | Category: FDA | Name: FDA Drugs

La FDA refuerza la advertencia de que el estreñimiento no tratado causado por el medicamento para tratar la esquizofrenia clozapina (Clozaril) puede provocar graves problemas intestinales

La FDA refuerza la advertencia de que el estreñimiento no tratado causado por el medicamento para tratar la esquizofrenia clozapina (Clozaril) puede provocar graves problemas intestinales

Published: Apr 6, 2026 | Category: FDA | Name: FDA Drugs

Los resultados iniciales de un ensayo de seguridad revela un mayor riesgo de padecer problemas graves relacionados con el corazón y cáncer con los medicamentos para la artritis y la colitis ulcerosa Xeljanz y Xeljanz de liberación prolongada (tofacitin

Los resultados iniciales de un ensayo de seguridad revela un mayor riesgo de padecer problemas graves relacionados con el corazón y cáncer con los medicamentos para la artritis y la colitis ulcerosa Xeljanz y Xeljanz de liberación prolongada (tofacitinib)

Published: Apr 6, 2026 | Category: FDA | Name: FDA Drugs

Meds For Vets, LLC - 714361 - 08/15/2025

Unapproved New Animal Drug/Adulterated/Misbranded

Published: Apr 6, 2026 | Category: FDA | Name: FDA Drugs

Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity

Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity. Preliminary evaluation does not suggest a causal link.

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause

FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause. Stop medicine if signs and symptoms of liver injury occur.

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis

Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis. Monitor liver tests often for early identification of worsening liver function.

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

FDA adds Boxed Warning about a rare but serious allergic reaction called anaphylaxis with the multiple sclerosis medicine glatiramer acetate (Copaxone, Glatopa)

FDA adds Boxed Warning about a rare but serious allergic reaction called anaphylaxis with the multiple sclerosis medicine glatiramer acetate (Copaxone, Glatopa). Treat immediately if symptoms worsen or do not go away shortly after an injection.

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names)

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Scōp (scopolamine transdermal system)

The antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases.

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD

The U.S. Food and Drug Administration (FDA) is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) – including certain formulations of amphetamine and methylphenidate – to warn about the risk of weight loss and other adverse rea

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

FDA is requiring opioid pain medicine manufacturers to update prescribing information regarding long-term use

FDA is requiring safety labeling changes for opioid pain medicines to further emphasize and characterize the risks associated with long-term use.

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

FDA removes risk evaluation and mitigation strategy (REMS) program for the antipsychotic drug Clozapine

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

FDA to recommend additional, earlier MRI monitoring for patients with Alzheimer’s disease taking Leqembi (lecanemab)

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

FDA Is Requiring Warning about Vitamin B6 Deficiency and Associated Seizures for Drug Products Containing Carbidopa/Levodopa

FDA has notified application holders for all drug products containing carbidopa/levodopa that the Agency is requiring the addition of a warning, and corresponding revisions, to the prescribing information.

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (avacopan) for Severe Active Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated Vasculitis

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

BK251289- Plasmacell-C Disposable Set

The Plasmacell-C disposable set is intended for collection of plasma by membrane filtration.

Published: Apr 3, 2026 | Category: FDA | Name: FDA Biologics

As They Grow: Teaching Your Children How To Use Medicines Safely

How to start talking to your children about medicines and how you make medicine decisions for yourself and for them from ages 3-12.

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)

Stay informed on FDA updates and press announcements about recalls involving angiotensin II receptor blockers (ARBs) like valsartan and losartan. Discover key safety alerts, reasons for recalls, and the latest FDA actions to ensure drug safety and availability.

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

Stop - Learn - Go: Tips for Talking with Your Pharmacist to Learn How to Use Medicines Safely

Points to discuss with your pharmacist and other healthcare providers

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

FDA Issues Draft Guidance for Industry on the Design and Evaluation of Comparative Analytical Studies for Biosimilarity

CDER Statement

Published: Apr 3, 2026 | Category: FDA | Name: FDA Drugs

FDA alerts consumers and pet owners of Silver Star Brand’s voluntary recall of homeopathic drug products

The Food and Drug Administration is alerting consumers and pet owners about a voluntary recall of certain lots of eight products – six products for humans, including four Native Remedies and two Healthful Naturals, and two PetAlive products for pets – distributed by Silver Star Brands Inc.

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA alerts consumers of Sprayology’s voluntary nationwide recall of homeopathic water-based medicines due to microbial contamination

FDA issues alert about a voluntary recall of all lots with expiration dates from October 2018 to July 2022 of Sprayology’s water-based homeopathic product line for human use.

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA alerts patients and health care professionals that some EpiPen auto-injectors may not readily slide out of carrier tube

FDA is alerting patients, caregivers and health care professionals that the labels attached to some EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product.

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA alerts health care professionals and patients not to use drug products intended to be sterile from Promise Pharmacy

The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products intended to be sterile that were produced in an inadequately designed processing room and distributed by Promise Pharmacy due to lack of sterility assurance.

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA alerts consumers not to use two e-liquids sold by HelloCig Electronic Technology

The U.S. Food and Drug Administration is alerting consumers, particularly males, not to purchase or use two e-liquids sold by HelloCig Electronic Technology Co. Ltd. that contain undeclared prescription drugs tadalafil and/or sildenafil. FDA laboratory analysis confirmed “E-Cialis HelloCig E-Liquid”

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA warns compounders not to use glutathione from Letco Medical to compound sterile drugs

Agency is aware of adverse events related to compounded glutathione injection

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA alerts patients of McDaniel Life-Line’s voluntary recall of Indian Herb

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA alerts patients and healthcare professionals to Infusion Options’ voluntary recall due to quality issues

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA alerts consumers not to use Kratom NC’s products

FDA is warning consumers not to use products marketed by Kratom NC, of Wilmington, North Carolina, due to microbial contamination.

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA advises patients not to use Herbal Doctor Remedies’ medicines

FDA advises patients not to use any drugs manufactured by Herbal Doctor Remedies, Monterey Park, California, because these drugs were made under poor conditions.

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

July - September 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

January - March 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

October - December 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

April - June 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA advises consumers not to use Rompe Pecho cough syrup

FDA advises consumers not to use Rompe Pecho EX and Rompe Pecho CF cough syrups distributed by Efficient Laboratories, Inc., Miami, FL, due to microbial contamination risks. These are over-the-counter medicines for children six years and older. FDA recommends consumers stop using these medicines.

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA alerts patients and health care professionals of Amneal and Impax Laboratories epinephrine auto-injector device malfunctions

FDA alerts consumers and healthcare proffessionals to immediately inspect certain lots of Amnal and Impax epinephrine auto-injector devices

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA updates on hand sanitizers consumers should not use

FDA Warns consumers and healthcare professionals of Hand Sanitizers contaminated with Methanol

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem

FDA Advises Consumers Not to Use Eskbiochem Hand Sanitizers due to the potential presence of methanol

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA advises consumers not to use goldenseal root powder distributed by Maison Terre

FDA advises consumers and health care professionals not to use goldenseal root powder repackaged and distributed by Maison Terre, Little Rock, Arkansas, due to microbial contamination.

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA alerts health care professionals and oncology clinical investigators about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA Alerts of Perrigo's voluntary albuterol inhaler recall

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma Solutions for Perrigo Pharmaceutical Company

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA Alerts Healthcare Professionals About the Risk of Medication Errors with Tranexamic Acid Injection Resulting in Inadvertent Intrathecal (Spinal) Injection

The U.S. Food and Drug Administration is alerting health care professionals about the risk of inadvertent intrathecal administration of tranexamic acid injection. Intrathecal administration of tranexamic acid injection may result in serious life-threatening injuries, including seizures, cardiac arrh

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA updates vinca alkaloid labeling for preparation in intravenous infusion bags only

FDA alerts health care professionals to labeling updates recommending that vinca alkaloids are prepared for administration in intravenous infusion bags only.

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA advises health care professionals not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company)

FDA advises health care professionals not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company), due to microbial contamination risks

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)

FDA has announced its decision to withdraw approval of Pepaxto (melphalan flufenamide), which was approved for use in combination with dexamethasone to treat certain patients with multiple myeloma.

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA issues guidance on using remote oversight tools to help approve drugs

Published: Apr 2, 2026 | Category: FDA | Name: FDA Drugs

FDA warns patients and health care professionals not to use sterile products from North American Custom Laboratories LLC, dba FarmaKeio Superior Custom Compounding

FDA is warning patients and health care professionals not to use products intended to be sterile produced by North American Custom Laboratories LLC, FarmaKeio Superior Custom Compounding due to a lack of sterility assurance.

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

Aphreseller (Buy-herbal.com) Issues Voluntary Nationwide Recall of Kian Pee Wan Capsules Due the Presence of Undeclared Dexamethasone and Cyproheptadine

FOR IMMEDIATE RELEASE – 03/30/2026 - Flushing, New York, Aphreseller (Ebay seller ID), Buy-herbal.com is recalling all lots of Kian Pee Wan capsules to the consumer level. FDA analysis has found that the product contains the undeclared drug ingredients dexamethasone and cyproheptadine. Products cont

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

La FDA advierte a los consumidores que no compren ni usen los productos de Artri y Ortiga, pues pueden contener ingredientes farmacológicos ocultos

La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) advierte a los consumidores que no compren ni usen productos comercializados con variaciones de los nombres “Artri” u “Ortiga” debido a ingredientes farmacológicos activos ocultos que son potencialmente peligrosos

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

FDA warns consumers not to purchase or use Artri and Ortiga products, which may contain hidden drug ingredients

FDA is warning consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to potentially dangerous hidden active drug ingredients not listed on the product label. FDA urges consumers taking these products to immediately talk to their health care professio

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

FDA alerts customers to voluntary recall of compounded drugs due to sterility issues by Drug Depot, LLC, dba APS Pharmacy

FDA is alerting patients, health care professionals, veterinarians, and animal owners/caretakers about a voluntary recall by Drug Depot, LLC, doing business as APS Pharmacy, of certain unexpired compounded drugs due to a lack of sterility assurance.

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

Bosentan REMS requirements will change June 27, 2022

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

FDA alerts health care professionals of risks to patients exposed to xylazine in illicit drugs

Health care professionals should be cautious of possible xylazine inclusion in fentanyl, heroin, and other illicit drug overdoses, as naloxone may not be able to reverse its effects. FDA is aware of increasing reports of serious side effects from individuals exposed to fentanyl, heroin, and other il

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

Infants at Risk for Aluminum Toxicity with Unapproved Potassium Phosphates Drug Product

FDA is warning health care professionals and pharmacies to avoid using Hospira's unapproved potassium phosphates drug product in pediatric patients because the aluminum exposure from this product is unsafe for this population.

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

FDA warns consumers to not purchase or use Nose Slap and Soul Slap products marketed for alertness and energy boosting

FDA is warning consumers to not purchase or use Nose Slap and Soul Slap products, which are unapproved drugs marketed to promote alertness and boost energy.

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

Alerta del CDER: Las pastillas para la tos pediátricas G-Supress DX pueden contener un medicamento incorrecto dentro del empaque

La FDA está alertando a los consumidores y a las farmacias de que no utilicen ni vendan un lote específico de G-Supress DX Pediatric Drops Cough Suppressant, de venta libre, expectorante, descongestionante nasal, sabor a cereza, fabricado por Novis PR LLC.

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

G-Supress DX Pediatric Cough Drops may have incorrect drug in packaging

FDA is alerting consumers and pharmacies to not use or sell a specific lot of over-the-counter G-Supress DX Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Cherry Flavor, manufactured by Novis PR LLC, because it contains the incorrect product and may cause patient harm.

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination

FDA is warning consumers not to purchase and to immediately stop using Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair due to bacterial contamination, fungal contamination, or both.

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

FDA is changing the therapeutic equivalence rating for Accord Healthcare Inc.’s generics of Prograf (tacrolimus) oral capsules

Based on new data, the U.S. Food and Drug Administration is changing the therapeutic equivalence rating for tacrolimus oral capsule products manufactured by Accord Healthcare Inc. under abbreviated new drug application 091195.

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

FDA warns consumers not to use SnoreStop Nasal Spray by Green Pharmaceuticals due to potential contamination

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

Drug Safety Information

Drug Safety Information and resources for healthcare professionals

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

7 Things to Know About How You Can Find CDER’s Drug Safety Information

CDER’s role in providing timely, accessible, evidence-based information on a drug's safety is crucial. This drug safety information helps you and health care professionals understand the potential risks and benefits of medications.

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

FDA is alerting patients and health care professionals about the voluntary withdrawal of Oxbryta from the market due to safety concerns

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

FDA warns patients and health care professionals not to use compounded drugs from Fullerton Wellness

FDA is warning patients and health care professionals not to use drugs compounded and distributed by Fullerton Wellness LLC, Ontario, Calif., and distributed to patients by medical offices and clinics.

Published: Apr 1, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves First New Molecular Entity Under National Priority Voucher Program

The U.S. Food and Drug Administration today approved Foundayo (orforglipron) marking the fifth approval under the Commissioner's National Priority Voucher (CNPV) pilot program.

Published: Apr 1, 2026 | Category: FDA | Name: FDA Press Release

Henan Lvyuan Pharmaceutical Co. Ltd. - 722497 - 03/26/2026

CGMP/API/Adulterated

Published: Mar 31, 2026 | Category: FDA | Name: FDA Drugs

Microbiological Testing & Consulting, LLC - 720374 - 03/16/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 31, 2026 | Category: FDA | Name: FDA Drugs

FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (avacopan) for Severe Active Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated Vasculitis

Published: Mar 31, 2026 | Category: FDA | Name: FDA Drugs

Companies that Have Not Submitted Drug Amount Reports

Registrants that failed to provide annual amount reporting for calendar year 2024 are included on one of two lists on this page.

Published: Mar 31, 2026 | Category: FDA | Name: FDA Drugs

October - December 2025 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event Monitoring System (AEMS)

October - December 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Published: Mar 31, 2026 | Category: FDA | Name: FDA Drugs

Red Bull Extreme and Blue Bull Extreme may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Red Bull Extreme or Blue Bull Extreme, products promoted and sold for sexual enhancement on various websites and possibly in some retail stores. These products were identified during an inspection of Pure Vitamins and Natu

Published: Mar 31, 2026 | Category: FDA | Name: FDA Drugs

Boner Bears Honey may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Boner Bears Honey, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. This product was identified during an FDA inspection of Pure Vitamins and Natural Supplements LL

Published: Mar 31, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: INLURIYO

Published: Mar 30, 2026 | Category: FDA | Name: FDA Drugs

BK251300- Procleix Plasmodium Quality Control

Procleix® Plasmodium Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Plasmodium falciparum with the Procleix Plasmodium Assay.

Published: Mar 27, 2026 | Category: FDA | Name: FDA Biologics

Drug Trials Snapshots: CARDAMYST

Published: Mar 27, 2026 | Category: FDA | Name: FDA Drugs

Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle

This guidance provides recommendations for sponsors and other interested parties consider when collecting and submitting PPI to assist in FDA decision making.

Published: Mar 27, 2026 | Category: FDA | Name: FDA Biologics

FDA Approves First Gene Therapy for Severe Leukocyte Adhesion Deficiency Type I

The U.S. Food and Drug Administration today approved Kresladi (marnetegragene autotemcel), the first gene therapy for the treatment of severe Leukocyte Adhesion Deficiency Type I (LAD-I).

Published: Mar 26, 2026 | Category: FDA | Name: FDA Press Release

How Gene Therapy Can Cure or Treat Diseases

Scientists have worked for decades on ways to modify or replace genes to treat, cure, or prevent illness. Advancements in science technology are changing the way we define disease, develop drugs, and prescribe treatments. The FDA has approved gene therapies for cancer, rare diseases.

Published: Mar 26, 2026 | Category: FDA | Name: FDA Biologics

CASGEVY

CASGEVY indicated for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso occlusive crises (VOCs).

Published: Mar 26, 2026 | Category: FDA | Name: FDA Biologics

FY 2025 GDUFA Science and Research Report

This FY 2025 GDUFA Science and Research report describes active research projects and outcomes in eight chapters corresponding to those eight priority areas for FY 2025, with a ninth chapter that reports on additional generic drug science and research.

Published: Mar 25, 2026 | Category: FDA | Name: FDA Drugs

FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

Published: Mar 25, 2026 | Category: FDA | Name: FDA Drugs

Disposal of Unused Medicines: What You Should Know

Learn how to dispose of unused or expired drugs

Published: Mar 25, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves Drug to Treat Neurologic Manifestations of Hunter Syndrome

The U.S. Food and Drug Administration approved Avlayah (tividenofusp alfa-eknm) to treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II).

Published: Mar 25, 2026 | Category: FDA | Name: FDA Press Release

Guidance Recap Podcast | Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products

Published: Mar 25, 2026 | Category: FDA | Name: FDA Drugs

Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Magnesium Sulfate in Water for Injection, USP 4 g/100mL (NDC 70121-1720-3) Due to a Product Mix-up with Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL

Bridgewater, New Jersey, Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag, to the hospital level. A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride I

Published: Mar 24, 2026 | Category: FDA | Name: FDA Drugs

Flucelvax Quadrivalent

For active immunization of children and adolescents 4 years of age and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

Published: Mar 24, 2026 | Category: FDA | Name: FDA Biologics

General Biologics Guidances

This page displays links to General Biologics Guidance documents.

Published: Mar 24, 2026 | Category: FDA | Name: FDA Biologics

Over-The-Counter (OTC) Heartburn Treatment

There are three classes of OTC medications for the treatment of heartburn. Learn more.

Published: Mar 24, 2026 | Category: FDA | Name: FDA Drugs

2011 Drug Safety Communications

Published: Mar 24, 2026 | Category: FDA | Name: FDA Drugs

Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products - 05/19/2026

Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics.

Published: Mar 24, 2026 | Category: FDA | Name: FDA Drugs

Guidances | Drugs

Newly added and withdrawn guidances can be found at Guidances (Drugs). FDA guidance documents discuss the production, labeling, manufacturing of regulated products and denote FDA's current thinking and policy interpretation.

Published: Mar 24, 2026 | Category: FDA | Name: FDA Drugs

Information for Lantus (insulin glargine)

Published: Mar 24, 2026 | Category: FDA | Name: FDA Drugs

La FDA refuerza la advertencia de que el estreñimiento no tratado causado por el medicamento para tratar la esquizofrenia clozapina (Clozaril) puede provocar graves problemas intestinales

La FDA refuerza la advertencia de que el estreñimiento no tratado causado por el medicamento para tratar la esquizofrenia clozapina (Clozaril) puede provocar graves problemas intestinales

Published: Mar 24, 2026 | Category: FDA | Name: FDA Drugs

Yangzhou H&R Plastic Daily Chemical Co., Ltd. - 722736 - 03/18/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2026 | Category: FDA | Name: FDA Drugs

4U Health - 720527 - 03/17/2026

Premarket Approval/Adulterated

Published: Mar 24, 2026 | Category: FDA | Name: FDA Biologics

ImmunityBio, Inc. - 725468 - 03/13/2026

False & Misleading Claims/Misbranded

Published: Mar 24, 2026 | Category: FDA | Name: FDA Drugs

Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4

Guidance for Industry and FDA Staff: Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4

Published: Mar 24, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Avandia (rosiglitazone) labels now contain updated information about cardiovascular risks and use in certain patients

[2-03-2011] The U.S. Food and Drug Administration (FDA) is notifying the public that information on the cardiovascular risks (including heart attack) of the diabetes drug rosiglitazone has been added to the physician labeling and patient Medication Guide.

Published: Mar 23, 2026 | Category: FDA | Name: FDA Drugs

Paroxetine (marketed as Paxil) Information

Published: Mar 23, 2026 | Category: FDA | Name: FDA Drugs

Sertraline (marketed as Zoloft) Information

Published: Mar 23, 2026 | Category: FDA | Name: FDA Drugs

Escitalopram (marketed as Lexapro) Information

Published: Mar 23, 2026 | Category: FDA | Name: FDA Drugs

Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot CL6814 through June 30, 2026

This is the Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot CL6814 through June 30, 2026

Published: Mar 23, 2026 | Category: FDA | Name: FDA Biologics

Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot CL6814 through June 30, 2026

This is the Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot CL6814 through June 30, 2026

Published: Mar 23, 2026 | Category: FDA | Name: FDA Biologics

FDA Drug Safety Communication: Safety review update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death

[8-4-2011] The U.S. Food and Drug Administration (FDA) is updating the public about its ongoing safety review of recombinant human growth hormone (somatropin) and possible increased risk of death.

Published: Mar 23, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Update: Preliminary findings from ongoing investigations of CardioGen-82

[1-12-2012] The U.S. Food and Drug Administration (FDA) is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82 on July 25, 2011 by the manufacturer, Bracco Diagnostics, Inc.

Published: Mar 23, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)

[01-20-2012] The U.S. Food and Drug Administration (FDA) is informing the public that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML).

Published: Mar 23, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Clostridium difficile associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)

Published: Mar 23, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Interactions between certain HIV or hepatitis C drugs and cholesterol-lowering statin drugs can increase the risk of muscle injury

The U.S. Food and Drug Administration (FDA) is issuing updated recommendations concerning drug-drug interactions between drugs for human immunodeficiency virus (HIV) or hepatitis C virus (HCV) known as protease inhibitors and certain cholesterol-lowering drugs known as statins.

Published: Mar 23, 2026 | Category: FDA | Name: FDA Drugs

Valproate Information

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

April - June 2012 | Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS)

The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period April - June 2012 in the AERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

October - December 2012 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA issues agency-initiated proposed order regarding OTC monograph drugs containing acetaminophen

Today, FDA issued a proposed administrative order, to address a safety issue related to over-the-counter (OTC) monograph drug products containing acetaminophen.

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

Adenosine Information

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Reminder to healthcare providers and patients to enroll in the Avandia-Rosiglitazone Medicines Access Program

[11-04-2011] The U.S. Food and Drug Administration (FDA) is reminding healthcare providers and patients about the need to enroll in the Avandia-Rosiglitazone Medicines Access Program by November 17, 2011 in order to continue prescribing and receiving rosiglitazone-containing medicines (Avandia, Avan

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses

The U.S. Food and Drug Administration (FDA) is clarifying dosing and warning recommendations for the antidepressant Celexa (citalopram hydrobromide; also available in generic form).

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone

The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: New Warning and Contraindication for blood pressure medicines containing aliskiren (Tekturna)

The U.S. Food and Drug Administration (FDA) is warning of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Updated information on drug interactions between Victrelis (boceprevir) and certain boosted HIV protease inhibitor drugs

The U.S. Food and Drug Administration (FDA) is notifying the public that co-administration of Victrelis (boceprevir), a hepatitis C virus (HCV) protease inhibitor, along with certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors, is not recommended at this time because of

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies

The U.S. Food and Drug Administration (FDA) is informing the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid (lenalidomide).

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Cefepime and risk of seizure in patients not receiving dosage adjustments for kidney impairment

The U.S. Food and Drug Administration (FDA) is reminding health care professionals about the need to adjust the dosage of the antibacterial drug cefepime in patients with renal (kidney) impairment. There have been cases of a specific type of seizure called nonconvulsive status epilepticus associated

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran)

The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that preliminary results from a recently completed clinical study suggest that a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical a

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Seizure risk for multiple sclerosis patients who take Ampyra (dalfampridine)

The U.S. Food and Drug Administration (FDA) is updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis (MS) who are starting Ampyra (dalfampridine).

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

Sildenafil (marketed as Viagra and Revatio) Information

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA recommends against use of Revatio (sildenafil) in children with pulmonary hypertension

The U.S. Food and Drug Administration (FDA) is recommending that Revatio (sildenafil) not be prescribed to children (ages 1 through 17) for pulmonary arterial hypertension (PAH; high pressure in the blood vessels leading to the lungs).

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers

The U.S. Food and Drug Administration (FDA) is alerting the public that certain over-the-counter (OTC) products that are applied to the skin for the relief of mild muscle and joint pain have been reported to cause rare cases of serious skin injuries, ranging from first- to third-degree chemical burn

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Ongoing safety review of Parkinson’s drug Mirapex (pramipexole) and possible risk of heart failure

The U.S. Food and Drug Administration (FDA) is informing the public about a possible increased risk of heart failure with Mirapex (pramipexole), a drug used to treat Parkinson’s disease and restless legs syndrome.

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays

The U.S. Food and Drug Administration (FDA) is warning the public that accidental ingestion (swallowing) by children of over-the-counter (OTC; available without a prescription) eye drops used to relieve redness and nasal decongestant sprays can result in serious harm.

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Important change to heparin container labels to clearly state the total drug strength

The U.S. Food and Drug Administration (FDA) is notifying health care professionals, caregivers, and patients about a change to the container and carton labels for heparin products, which are blood-thinning agents that prevent the formation of blood clots.

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Safety review update of Chantix (varenicline) and risk of cardiovascular adverse events

The U.S. Food and Drug Administration (FDA) is informing the public about the results of a large, combined analysis (called a meta-analysis) of clinical trials that compared patients who received the smoking cessation drug Chantix (varenicline) to patients who received a placebo (an inactive treatme

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Warning against use of Xyrem (sodium oxybate) with alcohol or drugs causing respiratory depression

The U.S. Food and Drug Administration (FDA) is reminding healthcare professionals and patients that the combined use of Xyrem (sodium oxybate) with alcohol or central nervous system (CNS) depressant drugs can markedly impair consciousness and may lead to severe breathing problems (respiratory depres

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Serious skin reactions after combination treatment with the Hepatitis C drugs Incivek (telaprevir), peginterferon alfa, and ribavirin

The U.S. Food and Drug Administration (FDA) has received reports of serious skin reactions, some fatal, in patients taking the hepatitis C drug Incivek (telaprevir) in combination with the drugs peginterferon alfa and ribavirin. 

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves

The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves,

Published: Mar 22, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Planned return of CardioGen-82 to market with new Boxed Warning

[2-15-2012] The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals; in particular, the medical imaging community, about the planned return of CardioGen-82 to the U.S. market following the voluntary recall by the manufacturer, Bracco Diagnostics, Inc., on July 25, 2011.

Published: Mar 20, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Safety update on Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)

[04-22-2011] The U.S. Food and Drug Administration (FDA) continues to evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) and Crohn's disease.

Published: Mar 20, 2026 | Category: FDA | Name: FDA Drugs

Old OTC Heartburn Treatment

Over-The-Counter (OTC) Heartburn Treatment

Published: Mar 20, 2026 | Category: FDA | Name: FDA Drugs

Cardinal Health Issues Voluntary Nationwide Recall of Webcol™ Large Alcohol Prep Pad

DUBLIN, Ohio, March 19, 2026 – Cardinal Health has issued a voluntary recall for select lots of Webcol™ Large Alcohol Prep Pads (70% isopropyl alcohol) to the consumer level. The product is being recalled due to microbial contamination identified as Paenibacillus phoenicis.

Published: Mar 20, 2026 | Category: FDA | Name: FDA Drugs

Rosuvastatin Calcium (marketed as Crestor) Information

Published: Mar 20, 2026 | Category: FDA | Name: FDA Drugs

Comunicado de la FDA sobre la seguridad de los medicamentos: Recomendaciones modificadas para Celexa (citalopram bromhidrato) relacionadas con el riesgo potencial de ritmo cardiaco anormal con dosis altas

El 28 de marzo del 2012, la AdministraciÃ³n de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglÃ©s) clarificÃ³ recomendaciones sobre dosis y advertencias para el antidepresivo Celexa (citalopram bromhidrato; tambiÃ©n disponible como medicamento genÃ©rico).

Published: Mar 20, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide)

[8-24-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide; also marketed as generics) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the ele

Published: Mar 20, 2026 | Category: FDA | Name: FDA Drugs

FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma

On March 20, 2026, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL).

Published: Mar 20, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills containing drospirenone

[10-27-2011] The U.S. Food and Drug Administration (FDA) is continuing its review of the potential increased risk of blood clots with the use of birth control pills containing drospirenone.

Published: Mar 20, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone

[09-26-2011] The U.S. Food and Drug Administration (FDA) is informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills.

Published: Mar 20, 2026 | Category: FDA | Name: FDA Drugs

FDA Is Requiring Warning about Vitamin B6 Deficiency and Associated Seizures for Drug Products Containing Carbidopa/Levodopa

Published: Mar 20, 2026 | Category: FDA | Name: FDA Drugs

Complex Generics News

Generally, complex generics are products that have complex active ingredients, formulations, dosage forms, or routes of administration, or are complex drug-device combination products. Generics of complex brand name drugs (i.e., reference listed drugs) can be more difficult to develop.

Published: Mar 20, 2026 | Category: FDA | Name: FDA Drugs

FDA Schedules Public Meeting on the Commissioner’s National Priority Voucher Pilot Program

As part of the U.S. Food and Drug Administration’s continuous quality improvement efforts, the agency today published a Federal Register Notice seeking public comment on the Commissioner’s National Priority Voucher pilot program.

Published: Mar 20, 2026 | Category: FDA | Name: FDA Press Release

Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre la interacción entre el medicamento Victrelis (boceprevir) y ciertos medicamentos reforzados inhibidores de la proteasa del VIH

El 26 de abril del 2012, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) informó al público que, en estos momentos, no se recomienda tomar conjuntamente Victrelis (boceprevir), un inhibidor de la proteasa del virus de la hepatitis C (VHC) junto con cie

Published: Mar 19, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developing new malignancies

The U.S. Food and Drug Administration (FDA) is informing the public that we are aware of results from studies conducted inside and outside the United States that found that patients treated with Revlimid (lenalidomide) may be at an increased risk of developing new types of cancer compared to patient

Published: Mar 19, 2026 | Category: FDA | Name: FDA Drugs

Comunicado de la FDA sobre la seguridad de los medicamentos: Informe actualizado sobre la seguridad del medicamento Revlimid (lenalidomida) para el cáncer y el riesgo de nuevos tipos de neoplasias (nuevos tipos de cáncer)

El 7 de mayo del 2012, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) informó al público sobre el aumento en el riesgo de segundas neoplasias primarias (nuevos tipos de cáncer) en pacientes con mieloma múltiple de reciente diagnóstico, que tomaron Revl

Published: Mar 19, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod)

[12-20-2011] The U.S. Food and Drug Administration (FDA) has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod).

Published: Mar 19, 2026 | Category: FDA | Name: FDA Drugs

Medical Device Accessories - Describing Accessories and Classification Pathways

Provide guidance to about the regulation of accessories to medical devices. Intended to describe policy concerning the classification of accessories and to discuss the application of this policy to devices that are commonly used as accessories to other medical devices.

Published: Mar 19, 2026 | Category: FDA | Name: FDA Biologics

FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)

The Food and Drug Administration (FDA) is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.

Published: Mar 19, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Abnormal heart rhythms may be associated with use of Zofran (ondansetron)

[09-15-2011] The U.S. Food and Drug Administration (FDA) is informing the public of an ongoing safety review of the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride and their generics).

Published: Mar 19, 2026 | Category: FDA | Name: FDA Drugs

Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre la dosis intravenosa de 32 mg de ondansetrón (Zofran) y productos previamente mezclados de ondansetrón

[12-5-12] La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) notificó a los profesionales de la salud que ya no se comercializará la dosis intravenosa de 32 mg de Zofran (hidrocloruro de ondansetrón), un medicamento para prevenir las náuseas, debido al pot

Published: Mar 19, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves Fourth Product Under National Priority Voucher Program, Higher Dose Semaglutide

The U.S. Food and Drug Administration today approved a new higher dose (7.2 mg) of Wegovy (semaglutide) injection for weight loss and long-term maintenance of weight loss for certain adult patients.

Published: Mar 19, 2026 | Category: FDA | Name: FDA Press Release

FDA Drug Safety Communication: Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products

The U.S. Food and Drug Administration (FDA) is notifying health care professionals that the 32 mg, single intravenous (IV) dose of the antinausea drug Zofran (ondansetron hydrochloride) will no longer be marketed because of the potential for serious cardiac risks. 

Published: Mar 19, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs)

[04-15-2011] To further evaluate the safety of Long-Acting Beta-Agonists (LABAs) when used in combination with inhaled corticosteroids for the treatment of asthma, the U.S. Food and Drug Administration (FDA) is requiring the manufacturers of LABAs to conduct five randomized, double-blind, controlled

Published: Mar 19, 2026 | Category: FDA | Name: FDA Drugs

Comunicado de la FDA sobre la seguridad de los medicamentos: Casos poco comunes de quemaduras graves con el uso de analgésicos tópicos de venta libre para el dolor muscular y articular

13 de septiembre del 2012. La Administración de Alimentos y Medicamentos de Estados (FDA por sus siglas en inglés) cumple con avisar al público que se ha reportado que, en casos pocos comunes, ciertos productos de venta libre que se aplican sobre la piel para el alivio de dolor muscular y articular

Published: Mar 19, 2026 | Category: FDA | Name: FDA Drugs

Comunicado de la FDA sobre la seguridad de los medicamentos: Estudio de seguridad en curso sobre el medicamento Mirapex (pramipexole) para la enfermedad de Parkinson y el posible riesgo de insuficiencia cardíaca

19 de septiembre del 2012. La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) le informó al público sobre la posibilidad de un mayor riesgo de insuficiencia cardíaca con Mirapex (pramipexole), un medicamento usado para tratar la enfermedad de Parkinson y

Published: Mar 19, 2026 | Category: FDA | Name: FDA Drugs

Industry Information and Guidance

FDA review of biosimilar and interchangeable products requires a 351(k) biologics license application that includes information demonstrating biosimilarity.

Published: Mar 19, 2026 | Category: FDA | Name: FDA Drugs

FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)

Published: Mar 19, 2026 | Category: FDA | Name: FDA Drugs

Comunicado de la FDA sobre la seguridad de los medicamentos: Cambio importante en la etiqueta del envase de heparina para indicar claramente la potencia total del medicamento

[12-6-2012] La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) notificó a los profesionales de la salud, cuidadores y pacientes sobre un cambio en las etiquetas del recipiente y caja de productos de heparina, un agente anticoagulante que impide la formació

Published: Mar 19, 2026 | Category: FDA | Name: FDA Drugs

Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication - Due to Risk of Serious Liver Injury, FDA Restricts Use of Ocaliva in Primary Biliary Cholangitis Patients with Advanced Cirrhosis

FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis with advanced cirrhosis of the liver because some patients with cirrhosis who took Ocaliva, especially those with evidence of advanced cirrhosis, developed liver failure

Published: Mar 19, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Chantix (varenicline) drug label now contains updated efficacy and safety information

[7-22-2011] The U.S. Food and Drug Administration (FDA) has approved an updated drug label for the smoking cessation aid Chantix (varenicline) to include information about the efficacy and safety of the drug in two patient populations who may benefit greatly from giving up smokingÃ¢â‚¬â€�those with

Published: Mar 19, 2026 | Category: FDA | Name: FDA Drugs

Pioglitazone (marketed as Actos, Actoplus Met, Duetact, and Oseni) Information

Published: Mar 18, 2026 | Category: FDA | Name: FDA Drugs

Invokana, Invokamet, Invokamet XR (canagliflozin): MedWatch Safety Alert - Boxed Warning about Risk of Leg and Foot Amputations Removed

Based on FDA's review of new data from three clinical trials, the Boxed Warning about amputation risk from the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) prescribing information was removed.

Published: Mar 18, 2026 | Category: FDA | Name: FDA Drugs

Pentacel

For active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease caused by Haemophilus influenzae type b when administered to infants and children 6 weeks through 4 years of age (prior to fifth birthday).

Published: Mar 18, 2026 | Category: FDA | Name: FDA Biologics

Quadracel

Indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series

Published: Mar 18, 2026 | Category: FDA | Name: FDA Biologics

Noxafil (posaconazole) Briefing Materials

Briefing materials for the April 12, 2016 meeting of the FDA's Pediatric Advisory Committee

Published: Mar 18, 2026 | Category: FDA | Name: FDA Drugs

January – March 2015 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Products and potential signals of serious risks/new safety information that were identified for these products

Published: Mar 18, 2026 | Category: FDA | Name: FDA Drugs

Webinars and Outreach

CBER sponsored webinars for public and industry.

Published: Mar 18, 2026 | Category: FDA | Name: FDA Biologics

Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma - 05/12/2026

This webinar is intended to provide blood establishments and other stakeholders with an overview of OBRR’s approach to the review of biologics license applications for the manufacture of blood and blood components, including source plasma. In this event, OBRR staff will give presentations on select topics and address questions submitted by registra

Published: Mar 18, 2026 | Category: FDA | Name: FDA Biologics

Codeine Information

Codeine is an opioid pain reliever used to treat mild to moderately severe pain.

Published: Mar 18, 2026 | Category: FDA | Name: FDA Drugs

Use of Codeine and Tramadol Products in Breastfeeding Women - Questions and Answers

Answers to questions about certain opioid medications and their effects on breastfed infants

Published: Mar 18, 2026 | Category: FDA | Name: FDA Drugs

April – June 2015 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Products and potential signals of serious risks/new safety information that were identified for these products

Published: Mar 18, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS)

A U.S. Food and Drug Administration (FDA) review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS

Published: Mar 18, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals,

Published: Mar 18, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease

The Food and Drug Administration (FDA) is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death.

Published: Mar 18, 2026 | Category: FDA | Name: FDA Drugs

General Considerations for the Use of New Approach Methodologies in Drug Development

This draft guidance provides drug developers with a validation framework and general recommendations for using new approach methodologies (NAMs) in drug development.

Published: Mar 18, 2026 | Category: FDA | Name: FDA Drugs

FDA Releases Draft Guidance on Alternatives to Animal Testing in Drug Development

The U.S. Food and Drug Administration today issued draft guidance intended to help drug developers validate new approach methodologies (NAMs) to be used instead of animal testing in drug development, and to bring safe, effective drugs to market sooner based on human-centric data.

Published: Mar 18, 2026 | Category: FDA | Name: FDA Press Release

FDA Clarifies Current Thinking on Pyrogen and Endotoxins Testing

Level 2 revision of the final guidance entitled, “Pyrogen and Endotoxins Testing – Questions and Answers

Published: Mar 18, 2026 | Category: FDA | Name: FDA Biologics

Procleix Plasmodium Assay

The Procleix Plasmodium Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Plasmodium species in whole blood specimens.

Published: Mar 17, 2026 | Category: FDA | Name: FDA Biologics

FDA Drug Safety Communication: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue

An FDA review to date has not identified adverse health effects from gadolinium retained in the brain after the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). All GBCAs may be associated with some gadolinium retention in the brain and other body tissues. Howe

Published: Mar 17, 2026 | Category: FDA | Name: FDA Drugs

Information on Dipeptidyl Peptidase-4 (DPP-4) Inhibitors

Published: Mar 17, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)

Based on new data from two large clinical trials, FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the

Published: Mar 17, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate

[2-2-2017] The U.S. Food and Drug Administration (FDA) is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate.

Published: Mar 17, 2026 | Category: FDA | Name: FDA Drugs

Fluoroquinolone Antimicrobial Drugs Information

Published: Mar 17, 2026 | Category: FDA | Name: FDA Drugs

Medication Errors Related to CDER-Regulated Drug Products

Who reviews medical error reports for human drugs? Meet FDA’s Division of Medication Error Prevention and Analysis. According to the National Coordinating Council for Medication Error Reporting and Prevention, “a medication error is any preventable event that may cause or lead to inappropriate medic

Published: Mar 17, 2026 | Category: FDA | Name: FDA Drugs

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.

Published: Mar 17, 2026 | Category: FDA | Name: FDA Drugs

Comunicado de la FDA sobre la seguridad de los medicamentos: Advertencia sobre el uso de Xyrem (oxibato de sodio) con bebidas alcohólicas o medicamentos ya que puede causar depresión respiratoria

El 17 de diciembre del 2012, La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) le recordó a los pacientes y profesionales de la salud que el uso combinado de Xyrem (oxibato de sodio) con bebidas alcohólicas o medicamentos depresores del sistema nervioso c

Published: Mar 17, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate)

Published: Mar 17, 2026 | Category: FDA | Name: FDA Drugs

DDI Webinar Series: Fluoroquinolone Safety Labeling Updates- April 4, 2017

Fluoroquinolone Safety Labeling Updates

Published: Mar 17, 2026 | Category: FDA | Name: FDA Drugs

FDA approves safety labeling changes for fluoroquinolones

Published: Mar 17, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems

The U.S. Food and Drug Administration (FDA) is taking several actions related to Nizoral (ketoconazole) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems and advising that it can lead to harmful drug interactions with other me

Published: Mar 17, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth

The U.S. Food and Drug Administration (FDA) is warning the public that the use of benzocaine, the main ingredient in over-the-counter (OTC) gels and liquids applied to the gums or mouth to reduce pain, is associated with a rare, but serious condition. This condition is called methemoglobinemia and r

Published: Mar 17, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA continues to receive reports of a rare, but serious and potentially fatal adverse effect with the use of benzocaine sprays for medical procedures

The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals that the Agency continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine sprays.

Published: Mar 17, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks

Based on our additional review, the U.S. Food and Drug Administration (FDA) is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of the

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

New Recommendations for Naloxone

To reduce the risk of death from opioid overdose, the U.S. Food and Drug Administration has made the following recommendations about the opioid reversal medicine, naloxone.

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

Benzodiazepine Drug Information

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use

The FDA is requiring the Boxed Warning be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions across all the medicines in the class.

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

Sleep Disorder (Sedative-Hypnotic) Drug Information

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines

[8-4-2011] The U.S. Food and Drug Administration (FDA) is informing the public that the Agency has approved updated drug labels for the pioglitazone-containing medicines to include safety information that the use of pioglitazone for more than one year may be associated with an increased risk of blad

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA approves label changes for use of general anesthetic and sedation drugs in young children

The U.S. Food and Drug Administration (FDA) is notifying the public that we have approved previously announced label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years. General anesthetic and sedation drugs are necessary for patients, including y

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

VAXELIS

VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type b. VAXELIS is approved for use as a 3 dose series in children 6 weeks through 4 years of age (prior t

Published: Mar 16, 2026 | Category: FDA | Name: FDA Biologics

FDA warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiotic after donor stem cell transplant

The U.S. Food and Drug Administration (FDA) is warning that the antibiotic azithromycin (Zithromax, Zmax) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant.

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes

FDA is strengthening current warnings that fluoroquinolones may cause serious decreases in blood sugar that can result in coma, and certain new mental health side effects. Monitor blood sugars frequently in elderly and diabetic patients.

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics

FDA is taking safety actions regarding over-the-counter benzocaine oral drug products and prescription local anesthetics.

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)

The U.S. Food and Drug Administration (FDA) is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir (Juluca, Tivicay, Triumeq) used to treat human immunodeficiency virus (H

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)

The Food and Drug Administration (FDA) is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system.

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease

The U.S. Food and Drug Administration (FDA) is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. Our recommendation is based on our review of the res

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

FDA limits packaging for anti-diarrhea medicine loperamide (Imodium) to encourage safe use

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

Nuance Health, LLC - 608405 - 06/26/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy - 598303 - 01/13/2020

Compounding Pharmacy/Adulterated Drug Products

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

OHM Pharma, Inc. - 586428 - 11/19/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

MannKind Corporation - 578282 - 10/23/2019

False & Misleading Claims/Misbranded

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

Lohxa LLC - 581785 - 09/10/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

Bella Rose Labs - 594246 - 11/22/2019

Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

Mr. Pink Collections, LLC - 593395 - 11/22/2019

Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

Whole Leaf Organics, LLC - 593176 - 11/22/2019

Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products

Published: Mar 16, 2026 | Category: FDA | Name: FDA Drugs

RotaTeq

RotaTeq is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by typesG1, G2, G3, G4, and G9.

Published: Mar 16, 2026 | Category: FDA | Name: FDA Biologics

RenatiLabs Inc. - 646353 - 06/01/2023

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 16, 2026 | Category: FDA | Name: FDA Biologics

MiMedx Group, Inc. - 662942 - 12/20/2023

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 16, 2026 | Category: FDA | Name: FDA Biologics

Kimera Labs, Inc. - 649343 - 09/01/2023

Investigational Device Exemptions (IDE)

Published: Mar 16, 2026 | Category: FDA | Name: FDA Biologics

BK251299- PlateletQuick PRP

The PlateletQuick PRP is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of peripheral blood at the patient point of care.

Published: Mar 16, 2026 | Category: FDA | Name: FDA Biologics

Kian Pee Wan may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Kian Pee Wan, a product promoted and sold as an appetite stimulant and for weight gain on various websites, including www.ebay.com, and possibly in some retail stores.

Published: Mar 13, 2026 | Category: FDA | Name: FDA Drugs

Elecsys Anti-HBc II

Elecsys Anti-HBc II is an in vitro immunoassay for the qualitative detection of antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma.

Published: Mar 13, 2026 | Category: FDA | Name: FDA Biologics

Influenza Vaccine Composition for the 2026-2027 U.S. Influenza Season

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on March 12, 2026, to discuss and make recommendations on the selection of influenza viruses for the composition of influenza vaccines for the 2026-2027 U.S. influenza season.

Published: Mar 13, 2026 | Category: FDA | Name: FDA Biologics

Elecsys Anti-HCV II

Intended Use for Elecsys Anti-HCV II Elecsys Anti-HCV II is an in vitro immunoassay for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma. Elecsys Anti-HCV II is intended to screen individual human donors, including volunteer donors of whole blood, ...

Published: Mar 13, 2026 | Category: FDA | Name: FDA Biologics

New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

Discover potential signals of serious risks and new safety information identified by the FDA's Adverse Event Monitoring System (AEMS). Learn how the FDA monitors and evaluates drugs for safety concerns, providing important updates on adverse events to protect public health.

Published: Mar 12, 2026 | Category: FDA | Name: FDA Drugs

August 5, 2022 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event Monitoring System (AEMS)

Learn about new safety information or potential signals of serious risks identified by the FDA Adverse Event Monitoring System (AEMS)

Published: Mar 12, 2026 | Category: FDA | Name: FDA Drugs

Quick Guide to Web Resources

Published: Mar 12, 2026 | Category: FDA | Name: FDA Biologics

Bell International Laboratories, Inc. - 669736 - 03/04/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 12, 2026 | Category: FDA | Name: FDA Drugs

Bell International Laboratories, Inc. - 669736 - 02/15/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 12, 2026 | Category: FDA | Name: FDA Drugs

BIMO/Team Biologics/Internet Surveillance/Other

This is the main page for the CBER BIMO/Team Biologics/Internet Surveillance/Other.

Published: Mar 11, 2026 | Category: FDA | Name: FDA Biologics

Transfusion/Donation Fatalities

This page provides details on the Notification Process for Transfusion Related Fatalities and Donation Related Deaths.

Published: Mar 11, 2026 | Category: FDA | Name: FDA Biologics

Vaccines Research

List of Vaccines Research.

Published: Mar 11, 2026 | Category: FDA | Name: FDA Biologics

Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) From Plasma-Derived Products

In recent years, questions have been raised concerning the potential risk of variant Creutzfeldt-Jakob disease (vCJD - a rare but fatal brain infection) for recipients of plasma- derived clotting factors.

Published: Mar 11, 2026 | Category: FDA | Name: FDA Biologics

What You Should Know - Reproductive Tissue Donation

Information that you may want to know before becoming a recipient of donated sperm.

Published: Mar 11, 2026 | Category: FDA | Name: FDA Biologics

OTC Monograph Drug User Fee Amendments (OMUFA): Understanding FY 2026 User Fees and Registration - 05/05/2026

The webinar provides an overview of the Over-the-Counter Drug User Fee Amendments (OMUFA) and describes the key elements of the amendments as it relates to OMUFA user fees.

Published: Mar 11, 2026 | Category: FDA | Name: FDA Drugs

Advancing Real-World Evidence Program Frequently Asked Questions

Published: Mar 11, 2026 | Category: FDA | Name: FDA Drugs

Azurity Pharmaceuticals, Inc. - 656489 - 02/24/2026

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

Published: Mar 11, 2026 | Category: FDA | Name: FDA Drugs

Pediatric Medical Countermeasures | Drugs

Pediatric Medical Countermeasures (Drugs) - Considerations for Bioterrorism Emergencies

Published: Mar 11, 2026 | Category: FDA | Name: FDA Drugs

FDA Launches New Adverse Event Look-Up Tool

FDA launched a new unified platform for analyzing adverse event reports. This platform — called the FDA Adverse Event Monitoring System (AEMS) — represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.

Published: Mar 11, 2026 | Category: FDA | Name: FDA Press Release

Procleix Zika Virus Assay

The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid test for the detection of Zika virus (ZIKV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, for transfusion. It is also intended for use in testing plasma or ser

Published: Mar 11, 2026 | Category: FDA | Name: FDA Biologics

FDA Adverse Event Monitoring System (AEMS) Electronic Submissions

This page provides drug and nonvaccine biological product manufacturers, distributors, packers, outsourcing facilities, and other interested parties with information about FDA Adverse Event Monitoring System (AEMS) electronic submissions and instructions on how to electronically submit postmarketing

Published: Mar 11, 2026 | Category: FDA | Name: FDA Drugs

FDA Adverse Event Monitoring System (AEMS) Public Dashboard

Four FAERS summary statistics reports updated with data through December 31, 2013.

Published: Mar 11, 2026 | Category: FDA | Name: FDA Drugs

FDA Adverse Event Monitoring System (AEMS)

Adverse event and medication error reports: Learn more about FDA's Adverse Event Monitoring System (AEMS).

Published: Mar 11, 2026 | Category: FDA | Name: FDA Drugs

BK251294- Hemanext ONE

Blood container set used to process and store CP2D/AS-3 or ACD-A/AS-3 Red Blood Cells Leukocytes Reduced, O2/CO2 Reduced. The Hemanext ONE system limits O2 and CO2 levels in the storage environment.

Published: Mar 11, 2026 | Category: FDA | Name: FDA Biologics

Procleix Ultrio Elite Assay

•Intended to screen for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA and to detect human immunodeficiency virus type 2 (HIV-2) RNA, in plasma and serum specimens from individual human donors, including donors of whole blood, blood compo

Published: Mar 11, 2026 | Category: FDA | Name: FDA Biologics

PROCLEIX WNV ASSAY

Product approval information is indicated for the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.

Published: Mar 10, 2026 | Category: FDA | Name: FDA Biologics

Alinity s HTLV I/ll

The Alinity s HTLV I/II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to human T-lymphotropic virus Type I and/or human T-lymphotropic virus Type II (anti-HTLV I/HTLV II) in human serum and plasma specimens on the Alinity s System.

Published: Mar 10, 2026 | Category: FDA | Name: FDA Biologics

Alinity s Chagas

The Alinity s Chagas assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to T. cruzi (the causative agent of Chagas disease) in human serum and plasma specimens on the Alinity s System.

Published: Mar 10, 2026 | Category: FDA | Name: FDA Biologics

Alinity s HBsAg and Alinity s HBsAg Confirmatory

The Alinity s HBsAg assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma specimens on the Alinity s System. The Alinity s HBsAg assay is intended to screen individual human donors, including

Published: Mar 10, 2026 | Category: FDA | Name: FDA Biologics

Alinity s HIV Ag/Ab Combo assay

Alinity s HIV Ag/Ab Combo Reagent Kit product information page

Published: Mar 10, 2026 | Category: FDA | Name: FDA Biologics

Novo Nordisk Inc. - 717576 - 03/05/2026

Postmarketing Adverse Drug Experience Reporting Requirements

Published: Mar 10, 2026 | Category: FDA | Name: FDA Drugs

COBAS TaqScreen West Nile Virus Test

Product approval information is indicated for the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, donors of whole blood and blood components, and other living donors. It is also intended for use in testing plasma specimens to screen organ donors w

Published: Mar 10, 2026 | Category: FDA | Name: FDA Biologics

Alinity s Anti-HBc

The Alinity s Anti-HBc assay is a chemiluminescent microparticle immunoassay (CMIA) for qualitative detection of antibody to hepatitis B core antigen (anti-HBc) in human serum and plasma specimens on the Alinity s System.

Published: Mar 10, 2026 | Category: FDA | Name: FDA Biologics

Bershtel Enterprises LLC dba WePackItAll - 570885 - 07/21/2021

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 10, 2026 | Category: FDA | Name: FDA Drugs

Fill It Pack It Inc - 570946 - 07/19/2021

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 10, 2026 | Category: FDA | Name: FDA Drugs

Stason Pharmaceuticals, Inc. - 604889 - 06/24/2021

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 10, 2026 | Category: FDA | Name: FDA Drugs

Results RNA, LLC - 578997 - 06/24/2021

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 10, 2026 | Category: FDA | Name: FDA Drugs

Spectrum Laboratory Products, Inc. - 573311 - 06/24/2021

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Mar 10, 2026 | Category: FDA | Name: FDA Drugs

RPK Pharmaceuticals Inc. - 613400 - 06/01/2021

Failure to Comply with Drug Listing Requirements/Misbranded

Published: Mar 10, 2026 | Category: FDA | Name: FDA Drugs

Beauty Manufacturing Solutions Corp. - 535116 - 05/27/2021

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 10, 2026 | Category: FDA | Name: FDA Drugs

Sprout Pharmaceuticals, Inc. - 610569 - 03/15/2021

False & Misleading Claims/Misbranded

Published: Mar 10, 2026 | Category: FDA | Name: FDA Drugs

Nephron Sterile Compounding Center LLC - 610867 - 02/19/2021

False & Misleading Claims/Misbranded

Published: Mar 10, 2026 | Category: FDA | Name: FDA Drugs

Metuchen Pharmaceuticals, LLC - 590713 - 09/18/2020

False & Misleading Claims/Misbranded

Published: Mar 10, 2026 | Category: FDA | Name: FDA Drugs

Enzymology Research Center, Inc. - 604613 - 03/01/2021

New Drug/Misbranded

Published: Mar 10, 2026 | Category: FDA | Name: FDA Drugs

Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy - 547409 - 02/04/2021

Compounding Pharmacy/Adulterated Drug Products

Published: Mar 10, 2026 | Category: FDA | Name: FDA Drugs

Village Pharmacy - 516174 - 02/01/2021

Compounding Pharmacy/Adulterated Drug Products

Published: Mar 10, 2026 | Category: FDA | Name: FDA Drugs

Mytilini Enterprises LLC dba Bedford Pharmacy Inc. - 486159 - 01/11/2021

Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated

Published: Mar 10, 2026 | Category: FDA | Name: FDA Drugs

Strong Fertility Center - 593262 - 12/11/2020

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 10, 2026 | Category: FDA | Name: FDA Biologics

California IVF Fertility Center - 598552 - 08/09/2021

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 10, 2026 | Category: FDA | Name: FDA Biologics

Valley Biosystems - 632553 - 10/14/2022

Bioresearch Monitoring Program

Published: Mar 10, 2026 | Category: FDA | Name: FDA Biologics

Namsa - 544884 - 10/07/2022

Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies

Published: Mar 10, 2026 | Category: FDA | Name: FDA Biologics

Toxikon Corporation/Labcorp Bedford LLC - 623581 - 10/25/2022

Good Laboratory Practice (GLP)

Published: Mar 10, 2026 | Category: FDA | Name: FDA Biologics

University Fertility Laboratory, Inc. - 577584 - 08/03/2023

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 10, 2026 | Category: FDA | Name: FDA Biologics

Surgenex LLC - 615254 - 09/20/2023

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 10, 2026 | Category: FDA | Name: FDA Biologics

Human Biologics of Texas/Globus Medical - 557325 - 08/28/2023

Human Biologics of Texas/Globus Medical, Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 10, 2026 | Category: FDA | Name: FDA Biologics

Abbott Laboratories - 669353 - 12/12/2024

Dietary Supplement/Adulterated

Published: Mar 10, 2026 | Category: FDA | Name: FDA Biologics

FDA Approves First Treatment for Patients with Cerebral Folate Transport Deficiency

The U.S. Food and Drug Administration today approved expanded use of Wellcovorin (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1).

Published: Mar 10, 2026 | Category: FDA | Name: FDA Press Release

Apollo Health And Beauty Care, Inc. - 593033 - 12/23/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Henan Kangdi Medical Devices Co. Ltd - 587699 - 12/03/2019

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

GPT Pharmaceuticals Private Ltd - 590938 - 12/17/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Unipharma, LLC - 585388 - 11/06/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Wild Child WA Pty Ltd. - 589463 - 12/06/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Pharmalab Enterprises, Inc. - 588432 - 12/10/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Dercher Enterprises, Inc., DBA Gordon Laboratories - 580346 - 09/13/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Soaptronic LLC - 596450 - 12/12/2019

Unapproved New Drugs/Misbranded

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Living Senior, LLC - 609864 - 08/19/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Predictive Biotech - 608322 - 08/17/2020

Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

PA Green Wellness LLC dba A Predictive Biotech Certified Facility - 608144 - 08/17/2020

Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

SilveryGuy - 609843 - 08/14/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Oxford Medical Instruments USA, Inc. - 609104 - 08/11/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Soluciones Cosmeticas, SA de CV - 609057 - 08/04/2020

CGMP/Adulterated/Unapproved/Misbranded

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

TAKA USA, INC. dba Cosmetic Innovations - 587521 - 07/29/2020

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

H-Lab Life - 609528 - 08/07/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

MMSTabs.com - 609461 - 08/03/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Canadian Chaga - 609097 - 08/06/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Predator Nutrition - 607136 - 10/23/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

New Life International - 609499 - 07/21/2020

Unapproved Chloroquine Phosphate Product

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Spartan Enterprises Inc. dba Watershed Wellness Center - 610876 - 10/30/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Beepothecary LLC - 608383 - 10/23/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

KVK-Tech, Inc. - 608236 - 10/08/2020

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Everything Aquatic - 610530 - 10/06/2020

Unapproved New Animal Drug Products

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Shilpa Medicare Limited - 607877 - 10/09/2020

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Quimica Magna de Mexico, S.A. de C.V. - 608751 - 10/15/2020

CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Foothills Professional Pharmacy, LTD - 598883 - 09/22/2020

Compounding Pharmacy/Adulterated Drug Products

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

Mr Frags, LLC - 611295 - 10/19/2020

Unapproved Chloroquine Phosphate Product

Published: Mar 9, 2026 | Category: FDA | Name: FDA Drugs

FDA Takes Further Steps to Streamline Biosimilar Development and Make Medicines More Affordable

The U.S. Food and Drug Administration today announced another major step in its initiative to streamline the development of biosimilar medicines, which are like “generic” versions of biologic drugs.

Published: Mar 9, 2026 | Category: FDA | Name: FDA Press Release

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

Biosimilarity

Published: Mar 8, 2026 | Category: FDA | Name: FDA Drugs

FDA Holds Meeting with States on Importation of Lower Cost Drugs

FDA held a meeting with several states to discuss the section 804 importation program (SIP), which allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer.

Published: Mar 6, 2026 | Category: FDA | Name: FDA Press Release

Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm

Intended Use for Elecsys HBsAg II Immunoassay for the in vitro qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma. Intended Use for Elecsys HBsAg II Auto Confirm Immunoassay for the in vitro qualitative confirmation of the presence of hepatitis B surface antigen..

Published: Mar 6, 2026 | Category: FDA | Name: FDA Biologics

Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection

Published: Mar 6, 2026 | Category: FDA | Name: FDA Drugs

Activities Report of the Generic Drug Program (FY 2025) – FDARA Title VIII Sections 807 and 805

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs).

Published: Mar 5, 2026 | Category: FDA | Name: FDA Drugs

Patient-Focused Drug Development Glossary

This glossary defines terms that will be used in the series of methodological Patient-Focused Drug Development (PFDD) FDA guidance documents that are required by the 21st Century Cures Act, and part of commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Act (PDUFA

Published: Mar 5, 2026 | Category: FDA | Name: FDA Drugs

FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma

On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

Published: Mar 5, 2026 | Category: FDA | Name: FDA Drugs

Premium Health Management Inc. dba Premium Health - 721474 - 02/20/2026

Failure to Register and List/Misbranded

Published: Mar 5, 2026 | Category: FDA | Name: FDA Drugs

FDA Grants Third Approval Under the National Priority Voucher Program

The U.S. Food and Drug Administration today approved teclistamab in combination with daratumumab hyaluronidase-fihj, Tec-Dara, to treat adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

Published: Mar 5, 2026 | Category: FDA | Name: FDA Press Release

FDA to Address Unused Opioids in American Homes

The U.S. Food and Drug Administration today issued a Request for Information (RFI) seeking public comment on potential new standards for in-home opioid disposal products.

Published: Mar 5, 2026 | Category: FDA | Name: FDA Press Release

New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers

Published: Mar 5, 2026 | Category: FDA | Name: FDA Drugs

FDA approves drug for pediatric patients with most common form of dwarfism

Published: Mar 4, 2026 | Category: FDA | Name: FDA Drugs

Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop - 06/08/2026

This workshop provides an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. Learn more.

Published: Mar 4, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: MYQORZO

MYQORZO is a cardiac myosin inhibitor used for treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.

Published: Mar 4, 2026 | Category: FDA | Name: FDA Drugs

October 5, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 10/05/2023

October 5, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

Published: Mar 4, 2026 | Category: FDA | Name: FDA Drugs

E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports

Published: Mar 4, 2026 | Category: FDA | Name: FDA Drugs

M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines

Published: Mar 4, 2026 | Category: FDA | Name: FDA Drugs

National Drug Code Format

FDA’s final rule, Revising the National Drug Code Format and Drug Label Barcode Requirements, adopts a uniform, 12-digit format for the national drug code (NDC).

Published: Mar 4, 2026 | Category: FDA | Name: FDA Drugs

Artri Ajo Rey and Artri Ajo King may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Artri Ajo King, a product promoted and sold for joint pain and arthritis on various websites, including amazon.com, and possibly in some retail stores.

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

FDA approves first generic of Flovent HFA for treatment of asthma

FDA announces the approval of the first generic of Flovent HFA (fluticasone propionate) inhalation aerosol, 44 micrograms per actuation, for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s

The U.S. Food and Drug Administration today announced the issuance of 30 warning letters to telehealth companies for making false and misleading claims regarding compounded GLP-1 products offered on their websites.

Published: Mar 3, 2026 | Category: FDA | Name: FDA Press Release

BK251232- PRF-Matrix System

The PRF-Matrix system is intended to be used for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient’s own peripheral blood at point-of-care.

Published: Mar 3, 2026 | Category: FDA | Name: FDA Biologics

Table of Pharmacogenomic Biomarkers in Drug Labeling

Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labeling may contain information on genomic biomarkers.

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

MaxLife Technologies Inc. dba Maxlife - 721453 - 02/20/2026

False & Misleading Claims/Misbranded

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

MEDVi, LLC dba MEDVi - 721455 - 02/20/2026

False & Misleading Claims/Misbranded

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

Better Health Labs, Inc. dba Measured - 721454 - 02/20/2026

False & Misleading Claims/Misbranded

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

Levity Inc. dba Levity - 717990 - 02/20/2026

False & Misleading Claims/Misbranded

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

Genesis Health International Inc. dba Genesis - 721451 - 02/20/2026

False & Misleading Claims/Misbranded

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

FitRX, LLC dba FitRx - 717987 - 02/20/2026

False & Misleading Claims/Misbranded

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

Aspen Aesthetics dba Fifty 410 - 721481 - 02/20/2026

False & Misleading Claims/Misbranded

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics - 721447 - 02/20/2026

False & Misleading Claims/Misbranded

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

BluefitMD - 721446 - 02/20/2026

False & Misleading Claims/Misbranded

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

Bliv Wellness LLC dba Bliv - 721479 - 02/20/2026

False & Misleading Claims/Misbranded

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

Belle Health LLC dba Belle - 721795 - 02/20/2026

False & Misleading Claims/Misbranded

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

Dripgym Mobile Parent, LLC dba Amp Health - 717992 - 02/20/2026

False & Misleading Claims/Misbranded

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

Alan Health Technologies Inc. dba Alan - 721814 - 02/20/2026

False & Misleading Claims/Misbranded

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

24HrDoc, Inc. dba 24HrDoc - 717984 - 02/20/2026

False & Misleading Claims/Misbranded

Published: Mar 3, 2026 | Category: FDA | Name: FDA Drugs

FDA Adverse Event Reporting System (FAERS) Public Dashboard

Four FAERS summary statistics reports updated with data through December 31, 2013.

Published: Mar 2, 2026 | Category: FDA | Name: FDA Drugs

FDA's Adverse Event Reporting System (FAERS)

Adverse event and medication error reports: Learn more about FDA's Adverse Event Reporting System (FAERS).

Published: Mar 2, 2026 | Category: FDA | Name: FDA Drugs

PAPZIMEOS

For the Treatment of Adults with Recurrent Respiratory Papillomatosis

Published: Mar 2, 2026 | Category: FDA | Name: FDA Biologics

Tissue and Tissue Product Questions and Answers

Published: Mar 2, 2026 | Category: FDA | Name: FDA Biologics

Common Ingredients in FDA-Approved Vaccines

Common ingredients found in vaccines that are commonly administered to healthy babies, children and adults are discussed to determine their safety and effectiveness.

Published: Mar 2, 2026 | Category: FDA | Name: FDA Biologics

Biological Product Deviations

Includes Human Tissue and Cellular and Tissue-Based Product (HCT/P) Deviation Reporting.

Published: Mar 2, 2026 | Category: FDA | Name: FDA Biologics

Vaccine Safety Questions and Answers

Questions and answers on vaccine safety.

Published: Mar 2, 2026 | Category: FDA | Name: FDA Biologics

Zostavax (Herpes Zoster Vaccine) Questions and Answers

Zostavax is an FDA licensed vaccine that helps to reduce the risk of getting herpes zoster (shingles) in individuals 50 years of age and older. Answers are provided to common questions about Zostavax and Herpes Zoster.

Published: Mar 2, 2026 | Category: FDA | Name: FDA Biologics

Emergency Use Authorization for Vaccines Explained

FDA recognizes the gravity of the current public health emergency and the importance of facilitating availability, as soon as possible, of vaccines to prevent COVID-19 - vaccines that the public will trust and have confidence in receiving.

Published: Mar 2, 2026 | Category: FDA | Name: FDA Biologics

Premarket Notification 510(k) Process for CBER-Regulated Products

CBER regulates medical devices related to licensed blood and cellular products while applying appropriate medical device laws and regulations.

Published: Mar 2, 2026 | Category: FDA | Name: FDA Biologics

Influenza Virus Vaccine Safety & Availability

Influenza (flu) is a contagious respiratory disease that is caused by influenza viruses. Influenza viruses infect the respiratory tract (nose, throat, and lungs) in humans.

Published: Mar 2, 2026 | Category: FDA | Name: FDA Biologics

Drug Trials Snapshot: HYRNUO

HYRNUO is a tyrosine-kinase inhibitor that is indicated for the treatment of adult patients with non-squamous non-small cell lung cancer. Learn more about the drug trials.

Published: Feb 27, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: EXDENSUR

Published: Feb 27, 2026 | Category: FDA | Name: FDA Drugs

ULTRA ADVANC3 and ULTRA ADVANC3 GOLD may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use ULTRA ADVANC3 sold on www.amazon.com or ULTRA ADVANC3 GOLD sold on www.naturistarex.com. These products are promoted and sold for joint pain on various other websites and possibly in some retail stores.

Published: Feb 27, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: KOMZIFTI

Published: Feb 26, 2026 | Category: FDA | Name: FDA Drugs

Online Advisory Letters

Published: Feb 26, 2026 | Category: FDA | Name: FDA Drugs

FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer

FDA granted accelerated approval to zongertinib, a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer.

Published: Feb 26, 2026 | Category: FDA | Name: FDA Drugs

FDA Grants Second Approval under the National Priority Voucher Pilot Program

The U.S. Food and Drug Administration today issued an approval for the lung cancer drug Hernexeos (zongertinib) as a part of the new Commissioner's National Priority Voucher (CNPV) pilot program.

Published: Feb 26, 2026 | Category: FDA | Name: FDA Press Release

Why Protecting Confidential Information is Key to the FDA’s "Gold Standard"

The FDA must maintain a delicate balance: being a model of openness regarding the scientific basis of its decisions, while safeguarding the proprietary secrets of the industries it regulates as well as personal data.

Published: Feb 26, 2026 | Category: FDA | Name: FDA Drugs

FDA approves drug for adult and pediatric patients aged 6 and older with allergic fungal rhinosinusitis

The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) with a history of sino-nasal surgery or for whom surgery is not advisable. This is the first approval for

Published: Feb 24, 2026 | Category: FDA | Name: FDA Drugs

FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation

Published: Feb 24, 2026 | Category: FDA | Name: FDA Drugs

MedisourceRx - 717970 - 12/12/2025

Compounding Pharmacy/Adulterated Drug Products

Published: Feb 24, 2026 | Category: FDA | Name: FDA Drugs

Dynamic Stem Cell Therapy - 712579 - 02/11/2026

Unapproved New Drugs/Unlicensed Biological Product Violations

Published: Feb 24, 2026 | Category: FDA | Name: FDA Biologics

AQ USA Inc., d.b.a Ross Healthcare Inc. - 719517 - 02/12/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Feb 24, 2026 | Category: FDA | Name: FDA Drugs

A. Nelson & Co. Ltd. - 720283 - 02/12/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Feb 24, 2026 | Category: FDA | Name: FDA Drugs

Guidance Documents for Rare Disease Drug Development

Published: Feb 23, 2026 | Category: FDA | Name: FDA Drugs

FDA Launches Framework for Accelerating Development of Individualized Therapies for Ultra-Rare Diseases

The U.S. Food and Drug Administration today issued draft guidance for sponsors seeking approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized controlled trials are not feasible due to small patient populations.

Published: Feb 23, 2026 | Category: FDA | Name: FDA Press Release

Division of Applied Regulatory Science

The Division of Applied Regulatory Science is located within FDA’s Office of Clinical Pharmacology and tackles emerging regulatory questions and develops and implements new regulatory review tools and approaches.

Published: Feb 23, 2026 | Category: FDA | Name: FDA Drugs

Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause

This is the draft guidance Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause

Published: Feb 23, 2026 | Category: FDA | Name: FDA Biologics

Rare Diseases at FDA

The FDA works with many people and groups, such as patients, caregivers, and drug and device manufactures, to support rare disease product development.

Published: Feb 22, 2026 | Category: FDA | Name: FDA Drugs

PDUFA VI: Fiscal Years 2018 - 2022

Published: Feb 20, 2026 | Category: FDA | Name: FDA Drugs

Generic Drugs Forum (GDF) 2026 - 04/22/2026

FDA's annual Generic Drugs Forum is a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generic medicines. Join us April 22-23, 2026.

Published: Feb 20, 2026 | Category: FDA | Name: FDA Drugs

FDA approves acalabrutinib with venetoclax for chronic lymphocytic leukemia or small lymphocytic lymphoma

Published: Feb 20, 2026 | Category: FDA | Name: FDA Drugs

BioXtek LLC - 715478 - 02/11/2026

Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)

Published: Feb 19, 2026 | Category: FDA | Name: FDA Biologics

Germaphobix - 720555 - 02/10/2026

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

Published: Feb 19, 2026 | Category: FDA | Name: FDA Biologics

Sperm Bank, Inc. dba Fertility Center of California - 694273 - 02/09/2026

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Feb 19, 2026 | Category: FDA | Name: FDA Biologics

Graduated ETP Technology

CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.

Published: Feb 18, 2026 | Category: FDA | Name: FDA Drugs

Bertrand P. Cole, D.O. - 723495 - 02/02/2026

Clinical Investigator

Published: Feb 18, 2026 | Category: FDA | Name: FDA Drugs

BK251296- PUREGRAFT SYNC Adipose Filtration System

The Puregraft SYNC System is indicated for use in the harvesting, filtering, and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.

Published: Feb 17, 2026 | Category: FDA | Name: FDA Biologics

Bertrand P. Cole, D.O./Activmed Practices and Research, LLC - 723495 - 02/02/2026

Clinical Investigator

Published: Feb 17, 2026 | Category: FDA | Name: FDA Drugs

Cosmetic Manufacturers Pty Ltd. - 719225 - 02/06/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Feb 17, 2026 | Category: FDA | Name: FDA Drugs

Shopaax.com - 626291 - 07/01/2022

Interstate Commerce/Food/Adulterated

Published: Feb 13, 2026 | Category: FDA | Name: FDA Drugs

MKS Enterprise, LLC - 624478 - 07/01/2022

Interstate Commerce/Food/Adulterated

Published: Feb 13, 2026 | Category: FDA | Name: FDA Drugs

FDA Grand Rounds – Adeno-associated Virus-mediated Gene Therapy: Advances, Immune Challenges, and Research Innovations - 02/19/2026

Adeno-associated Virus-mediated Gene Therapy: Advances, Immune Challenges, and Research Innovations

Published: Feb 13, 2026 | Category: FDA | Name: FDA Biologics

LOVION Chocolate with Ginseng for Men may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use LOVION Chocolate with Ginseng for Men, a product promoted and sold for sexual enhancement on various websites, including lovionusa.com, and possibly in some retail stores.

Published: Feb 13, 2026 | Category: FDA | Name: FDA Drugs

Fantasy Aphrodisiac Chocolate may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Fantasy Aphrodisiac Chocolate, a product promoted and sold for sexual enhancement on various websites, including gearisle.com, and possibly in some retail stores.

Published: Feb 13, 2026 | Category: FDA | Name: FDA Drugs

DTF Sexual Chocolate may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use DTF Sexual Chocolate, a product promoted and sold for sexual enhancement on various websites, including shopsexology.com, and possibly in some retail stores.

Published: Feb 13, 2026 | Category: FDA | Name: FDA Drugs

Boner Bears Chocolate may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Boner Bears Chocolate, a product promoted and sold for sexual enhancement on various websites, including lockoutsupplements.com, and possibly in some retail stores.

Published: Feb 13, 2026 | Category: FDA | Name: FDA Drugs

Hormone Replacement Therapies Can Help Women with Bothersome Menopausal Symptoms

The effects of menopause can make a woman’s daily life much harder, and therapies approved by the FDA can help. But too many women might not use these treatments to lessen their menopause symptoms because of the risks associated with these drugs described in the drug labels’ boxed warnings.

Published: Feb 13, 2026 | Category: FDA | Name: FDA Drugs

Nutrishus Brands, Inc. - 612938 - 07/28/2021

Unapproved New Drugs/Misbranded

Published: Feb 13, 2026 | Category: FDA | Name: FDA Drugs

Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank - 680039 - 02/09/2026

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Feb 12, 2026 | Category: FDA | Name: FDA Biologics

THYMOGLOBULIN

Product approval information is indicated for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant. Use in conjunction with concomitant immunosuppression.

Published: Feb 12, 2026 | Category: FDA | Name: FDA Biologics

Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers - 04/15/2026

An informative webinar on the FDA guidance Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

Published: Feb 12, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves Labeling Changes to Menopausal Hormone Therapy Products

The U.S. Food and Drug Administration has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to clarify risk considerations for these drugs.

Published: Feb 12, 2026 | Category: FDA | Name: FDA Press Release

Menopausal Hormone Therapies with Updated Prescribing Information

Find updated prescribing information for menopausal hormone therapies.

Published: Feb 12, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer

The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer.

Published: Feb 12, 2026 | Category: FDA | Name: FDA Press Release

Prescription Stimulant Medications

Information about FDA's work to address the impact of stimulant-related risks, including misuse, addiction, overdose, and diversion.

Published: Feb 12, 2026 | Category: FDA | Name: FDA Drugs

2026 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for the 2026 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (VRBPAC).

Published: Feb 12, 2026 | Category: FDA | Name: FDA Biologics

Vaccines and Related Biological Products Advisory Committee March 12, 2026 Meeting Announcement - 03/12/2026

On March 12, 2026, the Committee will meet in open session to discuss and make recommendations on the strain composition of influenza virus vaccines for use in United States during the 2026-2027 influenza season.

Published: Feb 12, 2026 | Category: FDA | Name: FDA Biologics

Boner Bears Chocolate Bars may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Boner Bears Chocolate Bars, a product promoted and sold for sexual enhancement on various websites, including elyxr.com, and possibly in some retail stores.

Published: Feb 11, 2026 | Category: FDA | Name: FDA Drugs

Pink Pussycat Aphrodisiac Chocolate may be harmful due to hidden drug ingredient

Published: Feb 11, 2026 | Category: FDA | Name: FDA Drugs

ilum Male Sexual Enhancement Chocolate may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use ilum Male Sexual Enhancement Chocolate, a product promoted and sold for sexual enhancement on various websites, including ebay.com, and possibly in some retail stores.

Published: Feb 11, 2026 | Category: FDA | Name: FDA Drugs

Rhino Choco VIP Chocolate for Men may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Rhino Choco VIP Chocolate for Men, a product promoted and sold for sexual enhancement on various websites, including usaless.com, and possibly in some retail stores.

Published: Feb 11, 2026 | Category: FDA | Name: FDA Drugs

Certification Process for Designated Medical Gases

This guidance explains how FDA administers the certification process and describes the annual reporting requirements for designated medical gases (DMGs).

Published: Feb 11, 2026 | Category: FDA | Name: FDA Drugs

FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

Full prescribing information for Keytruda and Keytruda Qlex will be posted on Drugs@FDA.

Published: Feb 10, 2026 | Category: FDA | Name: FDA Drugs

ProDx Health - 720762 - 02/10/2026

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

Published: Feb 10, 2026 | Category: FDA | Name: FDA Biologics

Regulatory Science at CDER

Explore the FDA's Center for Drug Evaluation and Research (CDER) regulatory science initiatives. Learn how CDER advances public health through innovative research, ensuring the safety, effectiveness, and quality of drugs. Stay informed on the latest scientific developments and guidelines.

Published: Feb 10, 2026 | Category: FDA | Name: FDA Drugs

2022 Meeting Materials, Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee)

Published: Feb 10, 2026 | Category: FDA | Name: FDA Drugs

iPLEDGE Risk Evaluation and Mitigation Strategy (REMS)

The goal of the iPLEDGE REMS is to mitigate the risk of embryo-fetal toxicity.

Published: Feb 10, 2026 | Category: FDA | Name: FDA Drugs

Questions and Answers on the iPLEDGE REMS

Published: Feb 10, 2026 | Category: FDA | Name: FDA Drugs

Boothwyn Pharmacy, LLC - 717525 - 01/16/2026

Compounding Pharmacy/Adulterated Drug Products

Published: Feb 10, 2026 | Category: FDA | Name: FDA Drugs

Bio-Medical Pharmaceutical Manufacturing Corporation - 719654 - 02/05/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Feb 10, 2026 | Category: FDA | Name: FDA Drugs

Louisville Reproductive Center - 722350 - 01/23/2026

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Feb 10, 2026 | Category: FDA | Name: FDA Biologics

Beach Weekend Management LLC dba Nic and Jet Fuel - 719715 - 02/05/2026

Unapproved New Drugs

Published: Feb 10, 2026 | Category: FDA | Name: FDA Drugs

Mark S. Dacey, M.D. - 722942 - 02/02/2026

Clinical Investigator

Published: Feb 10, 2026 | Category: FDA | Name: FDA Drugs

Conceive Fertility Center - 722459 - 01/27/2026

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Feb 10, 2026 | Category: FDA | Name: FDA Biologics

Signature Formulations, LLC - 718093 - 01/21/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Feb 10, 2026 | Category: FDA | Name: FDA Drugs

Central Coast Multispecialty Medical Group, Inc. - 722521 - 01/29/2026

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Feb 10, 2026 | Category: FDA | Name: FDA Biologics

FDA Launches Assessment of BHA, a Common Food Chemical Preservative

The U.S. Food and Drug Administration today launched a comprehensive re-assessment of butylated hydroxyanisole (BHA), a chemical preservative used in food.

Published: Feb 10, 2026 | Category: FDA | Name: FDA Press Release

FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs

Today, the U.S. Food and Drug Administration is announcing its intent to take decisive steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies

Published: Feb 6, 2026 | Category: FDA | Name: FDA Press Release

Safety labeling update for capecitabine and fluorouracil (5-FU) on risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency

The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers sho

Published: Feb 5, 2026 | Category: FDA | Name: FDA Drugs

BK251168- Precise Cell Concentration System

The Precise Cell Concentration System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a mixture of peripheral blood and bone marrow aspirate (BMA) at the patient's point of care.

Published: Feb 5, 2026 | Category: FDA | Name: FDA Biologics

INFORMED CONSENT TEMPLATE FOR INDIVIDUAL PATIENT EXPANDED ACCESS

Published: Feb 5, 2026 | Category: FDA | Name: FDA Drugs

Cefiderocol Injection

Cefiderocol Injection - FDA Identified Interpretive Criteria

Published: Feb 5, 2026 | Category: FDA | Name: FDA Drugs

E22 General Considerations for Patient Preference Studies

Published: Feb 5, 2026 | Category: FDA | Name: FDA Drugs

Rare Disease News, Events & Reports

Learn more about recent news and events related to rare diseases and read ARC Program Annual Reports.

Published: Feb 5, 2026 | Category: FDA | Name: FDA Drugs

Rare Disease Drug Approvals

This page describes recent rare disease drug approvals that received a CDER or FDA communication. This is not an exhaustive list of all rare disease drug approvals.

Published: Feb 5, 2026 | Category: FDA | Name: FDA Drugs

Rare Diseases Team

The Rare Diseases Program facilitates, supports and accelerates the development of drug and biologic products for the benefit of patients with rare disorders

Published: Feb 5, 2026 | Category: FDA | Name: FDA Drugs

Medical Product Development Tools at FDA

FDA resources for medical product development

Published: Feb 5, 2026 | Category: FDA | Name: FDA Drugs

FDA Takes New Approach to "No Artificial Colors" Claims

Today, the U.S. Food and Drug Administration took additional steps to support the transition of our nation’s food supply from the use of artificial petroleum-based colors to alternatives derived from natural sources.

Published: Feb 5, 2026 | Category: FDA | Name: FDA Press Release

Drug Trials Snapshots: WAYRILZ

Published: Feb 4, 2026 | Category: FDA | Name: FDA Drugs

Stay Informed about Small Business

Published: Feb 4, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: LEROCHOL

Published: Feb 4, 2026 | Category: FDA | Name: FDA Drugs

About CDER Small Business and Industry Assistance (SBIA)

CDER Small Business and Industry Assistance (SBIA) helps small pharmaceutical business and industry navigate the wealth of information that FDA offers, and provides assistance in understanding the regulation of human drug products.

Published: Feb 4, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: REDEMPLO

Published: Feb 4, 2026 | Category: FDA | Name: FDA Drugs

National Drug Code Directory

Published: Feb 3, 2026 | Category: FDA | Name: FDA Drugs

Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions

This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote consistency, facilitate efficien

Published: Feb 3, 2026 | Category: FDA | Name: FDA Biologics

CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections

ORA and CDER agree to replace and/or withdraw CPGs in favor of using guidance or procedural documents, as appropriate per GGP regulations.

Published: Feb 3, 2026 | Category: FDA | Name: FDA Drugs

Cohance Lifesciences Limited - 718812 - 01/30/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Feb 3, 2026 | Category: FDA | Name: FDA Drugs

HTO Nevada, Inc. dba Kirkman - 719074 - 01/27/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Feb 3, 2026 | Category: FDA | Name: FDA Drugs

FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available

FDA authorized undiluted, thawed Pfizer-BioNTech COVID-19 Vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month.

Published: Feb 3, 2026 | Category: FDA | Name: FDA Biologics

FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19

FDA releases guidance on how remote interactive evaluations will be requested by FDA and conducted for the duration of COVID-19 at drug facilities.

Published: Feb 3, 2026 | Category: FDA | Name: FDA Biologics

FDA In Brief: FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data

The FDA updates the emergency use authorization for COVID-19 convalescent plasma to reflect new analyzed data.

Published: Feb 3, 2026 | Category: FDA | Name: FDA Biologics

Umary contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Umary, a product promoted and sold for pain on various websites, including https://www.solovital.com and possibly in some retail stores.

Published: Feb 2, 2026 | Category: FDA | Name: FDA Drugs

Eurosirel S.P.A - 690733 - 01/26/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Feb 2, 2026 | Category: FDA | Name: FDA Drugs

Eurosirel S.P.A - 690733 - 11/20/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Feb 2, 2026 | Category: FDA | Name: FDA Drugs

RDEA Pilot Program Disclosure Agreement | Rare Disease Endpoint Advancement Pilot Program

Disclosure Agreement | Rare Disease Endpoint Advancement Pilot Program

Published: Feb 2, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: REDEMPLO

Published: Feb 2, 2026 | Category: FDA | Name: FDA Drugs

FDA Launches PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing

The U.S. Food and Drug Administration today began accepting requests to participate in the FDA PreCheck pilot program.

Published: Feb 1, 2026 | Category: FDA | Name: FDA Press Release

FDA Grand Rounds – Postmarket Regulation of Cosmetic Products: The Who, What, When, Why and How - 02/05/2026

Postmarket Regulation of Cosmetic Products: The Who, What, When, Why and How

Published: Jan 30, 2026 | Category: FDA | Name: FDA Biologics

IND Application Procedures: Exemptions from IND Requirements

Before submitting an IND application, investigators should refer to the Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs)— Determining Whether Human Research Studies Can Be Conducted Without an IND to determine whether they are exempt.

Published: Jan 30, 2026 | Category: FDA | Name: FDA Drugs

IND Application Procedures: Investigator's Responsibilities

This page provides the key points that investigators should consider in order to understand their responsibilities regarding an IND application.

Published: Jan 30, 2026 | Category: FDA | Name: FDA Drugs

IND Application Reporting: Overview

Published: Jan 30, 2026 | Category: FDA | Name: FDA Drugs

IND Application Procedures: Interactions with FDA

Sponsors of IND applications may obtain advice and guidance from FDA at any stage of IND development. Learn more.

Published: Jan 30, 2026 | Category: FDA | Name: FDA Drugs

IND Applications for Clinical Investigations: Overview

An overview of terms related to IND Applictions

Published: Jan 30, 2026 | Category: FDA | Name: FDA Drugs

IND Application Reporting: Protocol Amendments

Once an IND application is in effect, the sponsor of the application may amend the application as needed to ensure that the clinical investigations are conducted according to protocols included in the IND application.

Published: Jan 30, 2026 | Category: FDA | Name: FDA Drugs

General Drug Categories

Published: Jan 30, 2026 | Category: FDA | Name: FDA Drugs

Addresses to Send Applications

Published: Jan 30, 2026 | Category: FDA | Name: FDA Drugs

OMUFA Reauthorization: Fiscal Years 2026 - 2030

This page is the main website for information pertaining to OMUFA reauthorization activities, including high level meeting minutes with industry while negotiations are ongoing.

Published: Jan 29, 2026 | Category: FDA | Name: FDA Drugs

A Special Year, New Seal, and Renewed Commitment to the American People

The FDA has unveiled an official agency seal which signifies the many public health strides made over 120 years.

Published: Jan 28, 2026 | Category: FDA | Name: FDA Drugs

What Does FDA Approve? Part 2

The growing spread of rumors, misinformation and disinformation about science, medicine, and the FDA, is putting patients and consumers at risk. FDA is here to provide the facts.

Published: Jan 27, 2026 | Category: FDA | Name: FDA Drugs

FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma

On January 27, 2026, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cel

Published: Jan 27, 2026 | Category: FDA | Name: FDA Drugs

Charter of the Vaccines and Related Biological Products Advisory Committee

This is the Charter of the Vaccines and Related Biological Products Advisory Committee.

Published: Jan 27, 2026 | Category: FDA | Name: FDA Biologics

Center For Immunology Science, LLC - 719933 - 01/13/2026

Sponsor/Investigator

Published: Jan 27, 2026 | Category: FDA | Name: FDA Drugs

Fulijaya Manufacturing SDN. BHD. - 719172 - 01/14/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jan 27, 2026 | Category: FDA | Name: FDA Drugs

FDA/MHRA/Health Canada Symposium: Regulatory perspectives in good clinical practice, bioequivalence and good pharmacovigilance practice - 06/02/2026

This symposium will highlight current and emerging topics of interest to the industry related to good clinical practice, bioequivalence and good pharmacovigilance practice.

Published: Jan 26, 2026 | Category: FDA | Name: FDA Drugs

FluMist Quadrivalent

For active immunization of individuals 2 through 49 years of age for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

Published: Jan 26, 2026 | Category: FDA | Name: FDA Biologics

Genetic Metabolic Diseases Advisory Committee (GeMDAC) Charter

The Genetic Metabolic Diseases Advisory Committee (GeMDAC) advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs and biologic products for human use and as required.

Published: Jan 23, 2026 | Category: FDA | Name: FDA Drugs

Bodynplant - Online Advisory Letter

FDA Online advisory letter issued to Bodynplant/bodynplant.com for serious disease claims, including: cancer, diabetes, and HIV-AIDS

Published: Jan 22, 2026 | Category: FDA | Name: FDA Drugs

Products Claiming to "Cure" Cancer Are a Cruel Deception

Many ads on social media and "healthy" websites claim their products can cure cancer. They cannot.

Published: Jan 22, 2026 | Category: FDA | Name: FDA Drugs

Clinical Outcome Assessment (COA): Frequently Asked Questions

Clinical Outcome Assessments (COA) Frequently Asked Questions

Published: Jan 22, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots KYGEVVI

Published: Jan 21, 2026 | Category: FDA | Name: FDA Drugs

FDA Announces PreCheck Implementation Roadmap

The U.S. Food and Drug Administration announced that it will begin accepting applications on Feb. 1, 2026 for the PreCheck Pilot Program, a program to strengthen the domestic pharmaceutical supply chain. Learn more.

Published: Jan 21, 2026 | Category: FDA | Name: FDA Drugs

FDA ImportShield Program Delivers Impressive Results in Strengthening FDA Oversight at U.S. Ports of Entry

The U.S. Food and Drug Administration today announced its initial review of the effectiveness of the FDA ImportShield Program (FISP), which launched in August 2025 to modernize how the FDA reviews imported products.

Published: Jan 21, 2026 | Category: FDA | Name: FDA Press Release

FDA Takes Steps to Improve Gluten Ingredient Disclosure in Foods

Today, the U.S. Food and Drug Administration issued a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food.

Published: Jan 21, 2026 | Category: FDA | Name: FDA Press Release

Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites - 07/19/2022

Office of Study Integrity and Surveillance (OSIS) Workshop 2022&#58; CDERInspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites

Published: Jan 20, 2026 | Category: FDA | Name: FDA Drugs

The ABCs of Product-Specific Guidances | Audio Transcript

PSGs help streamline generic drug product development, promoting timely approval of abbreviated new drug application, or ANDA, submissions and increasing drug competition, ultimately improving patient access to high quality and affordable medicines.

Published: Jan 20, 2026 | Category: FDA | Name: FDA Drugs

Germaphobix - 720555 - 01/09/2026

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

Published: Jan 20, 2026 | Category: FDA | Name: FDA Biologics

Genovate - 720554 - 01/08/2026

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

Published: Jan 20, 2026 | Category: FDA | Name: FDA Biologics

Genetrace - 720529 - 01/08/2026

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

Published: Jan 20, 2026 | Category: FDA | Name: FDA Biologics

ProDx Health - 720762 - 01/08/2026

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

Published: Jan 20, 2026 | Category: FDA | Name: FDA Biologics

Integrity Partners Group - 716953 - 12/15/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jan 20, 2026 | Category: FDA | Name: FDA Drugs

Prodrome Sciences USA, LLC - 717959 - 01/08/2026

Sponsor/Unapproved Misbranded

Published: Jan 20, 2026 | Category: FDA | Name: FDA Drugs

M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

Published: Jan 20, 2026 | Category: FDA | Name: FDA Drugs

Tips for Section 804 Importation Program Proposals (SIPs)

FDA’s tips for section 804 state importation program (SIP) proposals provide information to assist states and tribes develop their proposals.

Published: Jan 16, 2026 | Category: FDA | Name: FDA Drugs

Section 804 Importation Program Policies and Authorizations

FDA has issued policies and taken actions to implement section 804 of the Federal Food, Drug and Cosmetic Act, which allows states and Indian tribes to import certain prescription drugs from Canada. Learn more.

Published: Jan 16, 2026 | Category: FDA | Name: FDA Drugs

Section 804 Importation Program Quality Assurance Tool

This quality assurance (QA) tool is designed to assist section 804 importation program (SIP) sponsors prepare proposals that fully comply with the requirements under the final rule.

Published: Jan 16, 2026 | Category: FDA | Name: FDA Drugs

Section 804 Importation Program (SIP) Proposals and FDA’s Review Process

Section 804 of the Federal Food, Drug and Cosmetic Act allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs without imposing additional risk to public health and safety.

Published: Jan 16, 2026 | Category: FDA | Name: FDA Drugs

Importation Program under Section 804 of the FD&C Act

FDA has developed a pathway under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that allows states and Indian tribes to import certain prescription drugs from Canada. Learn more.

Published: Jan 16, 2026 | Category: FDA | Name: FDA Drugs

FDA Authorizes Florida’s Drug Importation Program

FDA authorized Florida’s Agency for Health Care Administration’s Section 804 Importation Program (SIP) in accordance with section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA’s implementing regulations.

Published: Jan 16, 2026 | Category: FDA | Name: FDA Drugs

FDA Grand Rounds – Antibody Glycosylation Insights for High-Quality Biotherapeutics - 01/22/2026

Antibody Glycosylation Insights for High-Quality Biotherapeutics

Published: Jan 16, 2026 | Category: FDA | Name: FDA Biologics

Eco-NAMs Webinar Series | Gill Cell-Line Assay for Acute Fish Toxicity Prediction - 01/28/2026

The second webinar in the Eco-NAMs series on the use of NAMs in regulatory ecotoxicology will cover gill cell line-based prediction of acute fish toxicity. The webinar will be held on Wednesday, January 28, 2026 at 8:00 a.m. EST.

Published: Jan 15, 2026 | Category: FDA | Name: FDA Drugs

CDER SBIA YouTube Learning Library

FDA’s CDER Small Business and Industry Assistance (SBIA) is making available our YouTube learning library - now hundreds of our recordings are readily accessible.

Published: Jan 14, 2026 | Category: FDA | Name: FDA Drugs

Guiding Principles of Good AI Practice in Drug Development

CDER and CBER have collaborated with the European Medicines Agency (EMA) to develop 10 guiding principles that industry and product developers can consider when using artificial intelligence (AI) to advance drug and biological product development.

Published: Jan 14, 2026 | Category: FDA | Name: FDA Drugs

CDER SBIA On-Demand Learning Library

FDA’s CDER Small Business and Industry Assistance (SBIA) is making available our YouTube learning library - now hundreds of our recordings are readily accessible.

Published: Jan 13, 2026 | Category: FDA | Name: FDA Drugs

Split Real Time Application Review (STAR)

FDA is establishing a STAR pilot program, which aims to shorten the time from the date of complete submission to the action date, in order to allow earlier patient access to therapies that address an unmet medical need.

Published: Jan 13, 2026 | Category: FDA | Name: FDA Drugs

STAR Pilot Program Assessment

In October 2022, under the Prescription Drug User Fee Act reauthorization (PDUFA VII), FDA launched the Split Real Time Application Review (STAR) pilot program.

Published: Jan 13, 2026 | Category: FDA | Name: FDA Drugs

Winder Laboratories, LLC - 718601 - 01/07/2026

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jan 13, 2026 | Category: FDA | Name: FDA Drugs

Chemspec Chemicals Private Limited - 718403 - 12/23/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Jan 13, 2026 | Category: FDA | Name: FDA Drugs

Purushothaman Damodara Kumaran, M.D. - 721325 - 12/22/2025

In Vivo Bioavailability-Bioequivalence Studies – Clinical

Published: Jan 13, 2026 | Category: FDA | Name: FDA Drugs

2025 Drug Safety Communications

Published: Jan 13, 2026 | Category: FDA | Name: FDA Drugs

FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications

Published: Jan 13, 2026 | Category: FDA | Name: FDA Drugs

Novel Drug Approvals for 2026

Published: Jan 12, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves First Treatment for Children With Menkes Disease

The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients.

Published: Jan 12, 2026 | Category: FDA | Name: FDA Press Release

Apetamin — An Illegally Imported Weight Gain, Figure Augmentation Product

Apetamin, a brand name product, is manufactured overseas and illegally imported to the U.S. Although the FDA added the product to the Import Alert to prevent its importation, the product continues to find its way into the U.S. market, often marketed and sold online and in some retail stores.

Published: Jan 12, 2026 | Category: FDA | Name: FDA Drugs

FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials

The U.S. Food and Drug Administration today published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping drug developers make better use of available data, conduct more efficient clinical trials, and deliver safe and effective t

Published: Jan 12, 2026 | Category: FDA | Name: FDA Press Release

Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products

This draft guidance provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of Bayesian methods in clinical trials.

Published: Jan 12, 2026 | Category: FDA | Name: FDA Drugs

FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation

The U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT).

Published: Jan 11, 2026 | Category: FDA | Name: FDA Press Release

Cellular & Gene Therapy Products

CBER provides oversight of clinical studies, proactive scientific and regulatory advice to medical researchers and manufacturers of cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy.

Published: Jan 11, 2026 | Category: FDA | Name: FDA Biologics

2026 Safety and Availability Communications

Listing of 2026 Safety and Availability Communications

Published: Jan 10, 2026 | Category: FDA | Name: FDA Biologics

Modern Warrior Recalls “Modern Warrior Ready” Dietary Supplement Due to Undeclared 1,4-DMAA and Aniracetam, as Well as Tianeptine, Which has Not Been Approved for Supplement Use by the FDA.

[Phoenix, Arizona] – [12/22/25] – Modern Warrior is voluntarily recalling all lots of Modern Warrior Ready, a dietary supplement sold directly to consumers, after regulatory testing identified the presence of undeclared ingredients, including tianeptine, 1,4-DMAA, and aniracetam..Tianeptine can c

Published: Jan 9, 2026 | Category: FDA | Name: FDA Drugs

Biologics Guidances

This page displays links to Biologics Guidance documents.

Published: Jan 9, 2026 | Category: FDA | Name: FDA Biologics

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2026

This is the list of guidance topics CBER is considering for development during Calendar Year 2026

Published: Jan 9, 2026 | Category: FDA | Name: FDA Biologics

Anthony Trinh, 123Herbals LLC (123HERBALS.COM) Issues Nationwide Recall of Silintan Capsules Due to the Presence of Undeclared Meloxicam

Rosemead, CA, ANTHONY TRINH, 123herbals LLC is voluntarily recalling all lots of Silintan capsules to the consumer level. FDA analysis has found the product to be tainted with meloxicam. Meloxicam, is an approved Nonsteroidal Anti-Inflammatory Drug, (NSAID) indicated for management of osteoarthritis

Published: Jan 9, 2026 | Category: FDA | Name: FDA Drugs

Final Report FDA-EMA pilot program for the parallel assessment of quality-by-design elements of marketing applications

Final Report from the FDA-EMA pilot program for the parallel assessment of quality-by-design elements of marketing applications

Published: Jan 9, 2026 | Category: FDA | Name: FDA Drugs

Human Drug Imports

Human drug import information including PLAIR, safe importation action plan, and personal importation policy.

Published: Jan 9, 2026 | Category: FDA | Name: FDA Drugs

Importing Liquid Cough and Cold Medicine from India

FDA is aware of news reports of devastating, ongoing diethylene glycol (DEG) and ethylene glycol (EG) contamination in children’s cough and cold medicine in India.

Published: Jan 9, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose

The U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older

Published: Jan 8, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves First Over-the-Counter Naloxone Nasal Spray

The U.S. Food and Drug Administration approved the first naloxone nasal spray product available without a prescription.

Published: Jan 8, 2026 | Category: FDA | Name: FDA Drugs

FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities

FDA approved Symvess, the first acellular tissue engineered vessel for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.

Published: Jan 8, 2026 | Category: FDA | Name: FDA Biologics

FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review

Following a thorough safety review, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted.

Published: Jan 8, 2026 | Category: FDA | Name: FDA Biologics

Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle

Foster City, Calif., September 20, 2024 - Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in

Published: Jan 8, 2026 | Category: FDA | Name: FDA Drugs

BK251286- a) cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems and b) cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 systems

cobas HIV-1 is an in vitro nucleic acid amplification test for the quantitation of HIV-1 in EDTA plasma of HIV-1-infected individuals. cobas® HIV-1/HIV-2 Qualitative is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of HIV-1 and HIV-2 RNA in human serum

Published: Jan 8, 2026 | Category: FDA | Name: FDA Biologics

BK251248- PRiSM PRP

For the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care.

Published: Jan 8, 2026 | Category: FDA | Name: FDA Biologics

BK251245- Procleix® WNV/ Babesia Quality Control

Procleix® WNV/Babesia Quality Control is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Babesia microti with the Procleix Babesia Assay and RNA from WNV, with the Procleix WNV Assay and Procleix UltrioPlex W Assay.

Published: Jan 8, 2026 | Category: FDA | Name: FDA Biologics

FDA/Center for Research on Complex Generics (CRCG) Workshop on Visionary Standards: Advancing Science and Regulation in Generic Ophthalmic Products - 11/19/2025

This 2-day hybrid workshop will explore the evolving landscape of generic ophthalmic drug products, where increasing formulation complexity and innovative delivery systems present unique challenges for ensuring therapeutic equivalence and quality.

Published: Jan 8, 2026 | Category: FDA | Name: FDA Drugs

FDA Information Session on Generic Drug Research Needs & Opportunities for FY 2026 - 01/21/2026

FDA is hosting a virtual Information Session on Generic Drug Research Needs & Opportunities for fiscal year (FY) 2026 on Wednesday, January 21, 2026.

Published: Jan 7, 2026 | Category: FDA | Name: FDA Drugs

Cleared 510(k) Submissions with Supporting Documents - 2026

Published: Jan 6, 2026 | Category: FDA | Name: FDA Biologics

CBER Advanced Technologies Program

In regulating the pharmaceutical manufacturing sector, FDA realizes the need for a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality biologics.

Published: Jan 6, 2026 | Category: FDA | Name: FDA Biologics

FDA Roundup: July 23, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Jan 6, 2026 | Category: FDA | Name: FDA Drugs

FDA Roundup: July 14, 2023

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Jan 6, 2026 | Category: FDA | Name: FDA Drugs

FDA Roundup: January 19, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Jan 6, 2026 | Category: FDA | Name: FDA Drugs

Absolutely Natural - 715690 - 12/30/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jan 6, 2026 | Category: FDA | Name: FDA Drugs

LiquidCapsule Manufacturing, LLC - 717069 - 12/19/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jan 6, 2026 | Category: FDA | Name: FDA Drugs

Tower Laboratories Ltd. - 717456 - 12/23/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jan 6, 2026 | Category: FDA | Name: FDA Drugs

If Soap and Water Are Not Available, Hand Sanitizers May Be a Good Alternative

Washing your hands is one of the most important things you can do to avoid getting sick and spreading germs to people around you. The best way to prevent the spread of infections and decrease the risk of getting sick is by washing your hands with plain soap and water.

Published: Jan 6, 2026 | Category: FDA | Name: FDA Drugs

What You Should Know About Using Cannabis, Including CBD, When Pregnant or Breastfeeding

FDA strongly advises against the use of cannabidiol (CBD), tetrahydrocannabinol (THC), and marijuana in any form during pregnancy or while breastfeeding.

Published: Jan 6, 2026 | Category: FDA | Name: FDA Drugs

BK251197- “HsingChi” LipoSelector Disposable Fat Collection System (LS-1200)

The “HsingChi” LipoSelector Disposable Fat Collection System (LS-1200) is a sterile medical device intended for the processing of lipoaspirate tissue for the purpose of transferring autologous adipose tissue for aesthetic body contouring (lipofilling) in applications including various surgeries.

Published: Jan 5, 2026 | Category: FDA | Name: FDA Biologics

FDA approves therapy for rare blood disorder in pediatric patients 12 years and older

The U.S. Food and Drug Administration approved Cablivi (caplacizumab-yhdp) for injection to treat pediatric patients 12 years and older with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange and immunosuppressive therapy.

Published: Jan 5, 2026 | Category: FDA | Name: FDA Drugs

FDA approves first drug to treat serious complication of stem cell transplant

The U.S. Food and Drug Administration (FDA) approved Yartemlea (narsoplimab-wuug) injection to treat adults and children 2 years and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) as the first approved treatment option for TA-TMA.

Published: Jan 5, 2026 | Category: FDA | Name: FDA Drugs

FDA approves first oral treatment for anemia in thalassemia, an inherited blood disorder

The U.S. Food and Drug Administration (FDA) approved Aqvesme (mitapivat) tablets to treat anemia (low levels of red blood cells) in adults with alpha- or beta-thalassemia.

Published: Jan 5, 2026 | Category: FDA | Name: FDA Drugs

FDA Grand Rounds – Statistical Considerations for Drug Development in Rare Disease - 01/15/2026

Statistical Considerations for Drug Development in Rare Disease

Published: Jan 2, 2026 | Category: FDA | Name: FDA Biologics

July - September 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Published: Jan 2, 2026 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: VIZZ

Published: Dec 30, 2025 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: LYNKUET

Published: Dec 30, 2025 | Category: FDA | Name: FDA Drugs

Advanced Manufacturing Technologies Designation Program

FDA encourages the early adoption of advanced manufacturing technologies (AMTs) that have the potential to benefit patients by improving manufacturing and supply dependability and optimizing development time of drug and biological products.

Published: Dec 30, 2025 | Category: FDA | Name: FDA Drugs

Unipack LLC - 716621 - 12/19/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Dec 30, 2025 | Category: FDA | Name: FDA Drugs

Devalingam Mahalingam, M.D., Ph.D. - 721145 - 12/11/2025

Clinical Investigator

Published: Dec 30, 2025 | Category: FDA | Name: FDA Drugs

Private Label Skin Care, Inc. - 715880 - 12/18/2025

CGMP/OTC/Adulterated/Misbranded

Published: Dec 30, 2025 | Category: FDA | Name: FDA Drugs

Agebox Inc. - 718252 - 12/19/2025

Unapproved New Drug/Misbranded

Published: Dec 30, 2025 | Category: FDA | Name: FDA Drugs

Walgreen Company - 662158 - 12/19/2025

Failure to Register and List

Published: Dec 30, 2025 | Category: FDA | Name: FDA Drugs

Walgreen Company - 662158 - 09/12/2023

Failure to Register and List

Published: Dec 30, 2025 | Category: FDA | Name: FDA Drugs

FDA Finds Insufficient Data to Determine Safety of PFAS in Cosmetic Products

The U.S. Food and Drug Administration today released a congressionally mandated report under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) evaluating the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products.

Published: Dec 29, 2025 | Category: FDA | Name: FDA Press Release

Drug Trials Snapshot: RHAPSIDO

RHAPSIDO is a kinase inhibitor that is approved for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1-antihistamine treatment. Learn more about the drug trials.

Published: Dec 29, 2025 | Category: FDA | Name: FDA Drugs

Biological Product Deviation Reports Annual Summaries

Published: Dec 29, 2025 | Category: FDA | Name: FDA Biologics

CDER/Office of New Drugs Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs)

Published: Dec 29, 2025 | Category: FDA | Name: FDA Drugs

Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods

Gold Star Distribution, Inc. (Gold Star or “the Company”) is recalling all FDA regulated products listed in this press release due to the presence of rodent and avian contamination.

Published: Dec 27, 2025 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: DAWNZERA

Published: Dec 23, 2025 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: HERNEXEOS

Published: Dec 23, 2025 | Category: FDA | Name: FDA Drugs

Darmerica, LLC - 716152 - 12/08/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded

Published: Dec 23, 2025 | Category: FDA | Name: FDA Drugs

Guangdong Renhe Guozhuang Biotechnology Co., Ltd. - 719045 - 12/16/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Dec 23, 2025 | Category: FDA | Name: FDA Drugs

Medinatura New Mexico, Inc. - 716025 - 12/10/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Dec 23, 2025 | Category: FDA | Name: FDA Drugs

Revive Rx LLC dba Revive Rx Pharmacy - 709509 - 09/22/2025

Compounding Pharmacy/Adulterated Drug Products

Published: Dec 23, 2025 | Category: FDA | Name: FDA Drugs

Maria A. Carballosa, M.D. - 720805 - 12/12/2025

In Vivo Bioavailability-Bioequivalence Studies – Clinical

Published: Dec 23, 2025 | Category: FDA | Name: FDA Drugs

TITAN SARMS LLC - 719645 - 12/12/2025

Unapproved New Drugs

Published: Dec 23, 2025 | Category: FDA | Name: FDA Drugs

Dynamic Health Group dba SARMS AMERICA - 719257 - 12/12/2025

Unapproved New Drugs

Published: Dec 23, 2025 | Category: FDA | Name: FDA Drugs

Pinnacle Professional Research dba Pinnacle Peptides - 719337 - 12/12/2025

Unapproved New Drugs

Published: Dec 23, 2025 | Category: FDA | Name: FDA Drugs

SV Labs Corporation - 716503 - 12/09/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Dec 23, 2025 | Category: FDA | Name: FDA Drugs

Prime Sports Nutrition - 719433 - 12/12/2025

Unapproved New Drugs

Published: Dec 23, 2025 | Category: FDA | Name: FDA Drugs

Atomix LLC - 719111 - 12/12/2025

Unapproved New Drugs

Published: Dec 23, 2025 | Category: FDA | Name: FDA Drugs

Adverse Events and Product Deviation Guidances

This page lists Adverse Events and Product Deviation Guidance documents.

Published: Dec 22, 2025 | Category: FDA | Name: FDA Biologics

FDA approves first prescription oral medicine for iron deficiency in pediatric patients ages 10 and older

The U.S. Food and Drug Administration (FDA) approved Accrufer (ferric maltol) capsules to treat pediatric patients ages 10 and older with iron deficiency. Accrufer was approved in 2019 for adults with iron deficiency.

Published: Dec 22, 2025 | Category: FDA | Name: FDA Drugs

FDA approves drug to improve functional capacity and symptoms in adults with rare inherited heart condition

The U.S. Food and Drug Administration (FDA) approved Myqorzo (aficamten) tablets to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.

Published: Dec 22, 2025 | Category: FDA | Name: FDA Drugs

Prothrombin Complex Concentrate, Human-LANS

Published: Dec 22, 2025 | Category: FDA | Name: FDA Biologics

Pooled Plasma (Human), Solvent/Detergent Treated

Published: Dec 22, 2025 | Category: FDA | Name: FDA Biologics

Plasminogen, Human-tvmh

Published: Dec 22, 2025 | Category: FDA | Name: FDA Biologics

RIASTAP

Treatment of of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Published: Dec 22, 2025 | Category: FDA | Name: FDA Biologics

Handelnine Global Limited d/b/a as Navafresh Issues Nationwide Recall of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo), Due to Elevated Lead Levels

Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Lot Numbers CAM040 & CALO79-N of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo) to the consumer level. In test conducted by the Food and Drug Administration the product has been found to contain lead at levels up to 11,100

Published: Dec 22, 2025 | Category: FDA | Name: FDA Drugs

Coagulation Factors

Lists of the Coagulation Factors products

Published: Dec 22, 2025 | Category: FDA | Name: FDA Biologics

Coagulation Factor Xa (Recombinant), Inactivated-ZHZO

Published: Dec 22, 2025 | Category: FDA | Name: FDA Biologics

Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication

Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). Based on available data, the serious risks including the increase in thromboembolic

Published: Dec 22, 2025 | Category: FDA | Name: FDA Biologics

Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act

Published: Dec 22, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves Drug to Treat Chronic, Progressive Lung Disease

The U.S. Food and Drug Administration (FDA) approved Jascayd (nerandomilast) tablets to treat adults with progressive pulmonary fibrosis (PPF).

Published: Dec 19, 2025 | Category: FDA | Name: FDA Drugs

FDA Grants Two National Priority Vouchers

The U.S. Food and Drug Administration today awarded national priority vouchers under the Commissioner’s National Priority Voucher (CNPV) pilot program to two investigational products for their potential to increase access through affordability for American patients.

Published: Dec 19, 2025 | Category: FDA | Name: FDA Press Release

FDA Qualifies Total Hip Bone Mineral Density (BMD) as Surrogate Endpoint for Osteoporosis Drug Development

Published: Dec 19, 2025 | Category: FDA | Name: FDA Drugs

Standards Development for Regenerative Medicine Therapies

Section 3036 of the 21st Century Cures Act refers to the development of standards for regenerative medicine therapies, including products designated regenerative medicine advanced therapies.

Published: Dec 19, 2025 | Category: FDA | Name: FDA Biologics

Do Not Use: Black Salve is Dangerous and Called by Many Names

Salves that contain corrosive ingredients, including “black salve” and a number of other names, are dangerous and can be life-threatening. Here’s why.

Published: Dec 19, 2025 | Category: FDA | Name: FDA Drugs

August 5, 2022 Posting | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

July 29, 2022 Posting

Published: Dec 19, 2025 | Category: FDA | Name: FDA Drugs

FDA Explores New Contracting Approach to Advance Public Health Innovation

The U.S. Food and Drug Administration has issued a Request for Information (RFI) seeking input from venture capital firms on developing a new contracting approach to strengthen collaboration between the agency and America’s most innovative companies.

Published: Dec 19, 2025 | Category: FDA | Name: FDA Press Release

FDA Institutional Review Board Inspections

Information Sheet - Guidance for Institutional Review Boards and Clinical Investigators (FDA Institutional Review Board Inspections)

Published: Dec 18, 2025 | Category: FDA | Name: FDA Biologics

FDA Inspections of Clinical Investigators

Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors: FDA Inspections of Clinical Investigators

Published: Dec 18, 2025 | Category: FDA | Name: FDA Biologics

REMS Compliance Program

Published: Dec 18, 2025 | Category: FDA | Name: FDA Drugs

Processes and Practices Applicable to Bioresearch Monitoring Inspections

Processes and Practices Applicable to Bioresearch Monitoring Inspections; Guidance for Industry

Published: Dec 18, 2025 | Category: FDA | Name: FDA Drugs

Coagulation Factor VIIa (Recombinant) - JNCW

Published: Dec 18, 2025 | Category: FDA | Name: FDA Biologics

Antihemophilic Factor (Recombinant)

Lists contain the Antihemophilic Factor (Recombinant) products with supporting documents.

Published: Dec 18, 2025 | Category: FDA | Name: FDA Biologics

Antithrombin III (Human)

Published: Dec 18, 2025 | Category: FDA | Name: FDA Biologics

Medication Health Fraud for Specific Diseases and Conditions

FDA has identified condition-specific medication health fraud scams that can pose significant risks to consumers.

Published: Dec 18, 2025 | Category: FDA | Name: FDA Drugs

FDA Roundup: August 25, 2023

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Dec 18, 2025 | Category: FDA | Name: FDA Drugs

FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection

On December 17, 2025, the Food and Drug Administration approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for subcutaneous injection for adult patients

Published: Dec 18, 2025 | Category: FDA | Name: FDA Drugs

HIBERIX

HIBERIX is a vaccine indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday).

Published: Dec 17, 2025 | Category: FDA | Name: FDA Biologics

FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer

On December 17, 2025, the Food and Drug Administration (FDA) approved rucaparib (Rubraca, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-dire

Published: Dec 17, 2025 | Category: FDA | Name: FDA Drugs

Cleared 510(k) Submissions with Supporting Documents - 2025

Published: Dec 17, 2025 | Category: FDA | Name: FDA Biologics

BK251265 - Ortho Elution Kit

The Ortho® Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detection and/or identification. The Ortho Elution Kit is an accessory for sample preparation only and does not return diagnostic results for an analyte. Intended for professiona

Published: Dec 17, 2025 | Category: FDA | Name: FDA Biologics

Procleix Babesia Assay

The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens.

Published: Dec 17, 2025 | Category: FDA | Name: FDA Biologics

C3TI Compass (Knowledge Repository)

Centralized knowledge repository for clinical trial innovation

Published: Dec 17, 2025 | Category: FDA | Name: FDA Drugs

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

This guidance clarifies how FDA evaluates RWD to determine whether they are of sufficient quality for generating RWE for medical devices.

Published: Dec 17, 2025 | Category: FDA | Name: FDA Biologics

Heparin Importation

Therefore, in order to ensure that batches of imported heparin continue to meet regulatory standards, FDA is requiring that all lots of Heparin Sodium be required to be in compliance with latest USP specifications.

Published: Dec 16, 2025 | Category: FDA | Name: FDA Drugs

Fractionated Plasma Products

Listing of fractionated plasma products

Published: Dec 16, 2025 | Category: FDA | Name: FDA Biologics

Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices

Published: Dec 16, 2025 | Category: FDA | Name: FDA Drugs

FDA Drug Competition Action Plan | Improving the efficiency of the generic drug development, review, and approval process

By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of ANDAs submitted to the Agency for approval.

Published: Dec 16, 2025 | Category: FDA | Name: FDA Drugs

ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs

Published: Dec 16, 2025 | Category: FDA | Name: FDA Drugs

BK251285- Elecsys Syphilis

Elecsys Syphilis is an in vitro immunoassay for the qualitative detection of total antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma.

Published: Dec 16, 2025 | Category: FDA | Name: FDA Biologics

MediNatura New Mexico, Inc. Expands Voluntary Nationwide Recall of ReBoost Nasal Spray and to include ClearLife Allergy Nasal Spray Due to Microbial Contamination

FOR IMMEDIATE RELEASE – December 16, 2025 – Albuquerque, New Mexico, MediNatura New Mexico, Inc. is voluntarily recalling all lots of ReBoost Nasal Spray to the consumer level. The product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter,

Published: Dec 16, 2025 | Category: FDA | Name: FDA Drugs

StuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared Sildenafil and Tadalafil

Huntsville, Texas — StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are active ingredients in FDA-approved prescription drugs used to treat male erectile dys

Published: Dec 16, 2025 | Category: FDA | Name: FDA Drugs

Zydus Lifesciences Limited - 685224 - 12/09/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Dec 16, 2025 | Category: FDA | Name: FDA Drugs

Zydus Lifesciences Limited - 685224 - 12/09/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Dec 16, 2025 | Category: FDA | Name: FDA Drugs

Zydus Lifesciences Limited - 685224 - 08/29/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Dec 16, 2025 | Category: FDA | Name: FDA Drugs

Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS - 719339 - 12/12/2025

Unapproved New Drugs/Misbranded

Published: Dec 16, 2025 | Category: FDA | Name: FDA Drugs

3D Imaging Drug Design and Development LLC - 716213 - 12/04/2025

CGMP/Positron Emission Tomography (PET) Drugs/Adulterated

Published: Dec 16, 2025 | Category: FDA | Name: FDA Drugs

Microvascular Tissue, Inc. - 710860 - 12/03/2025

CGMP/Deviations/Biologics License Application (BLA)

Published: Dec 16, 2025 | Category: FDA | Name: FDA Biologics

Green Valley Fertility Partners - 720249 - 12/03/2025

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Dec 16, 2025 | Category: FDA | Name: FDA Biologics

Sklar Personal Care Inc. - 716656 - 12/09/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Dec 16, 2025 | Category: FDA | Name: FDA Drugs

FDA approves drug for type of abnormally fast heart rhythm

The U.S. Food and Drug Administration (FDA) has approved Cardamyst (etripamil) nasal spray to treat episodes of paroxysmal supraventricular tachycardia (PSVT), a condition where the heart beats abnormally fast.

Published: Dec 15, 2025 | Category: FDA | Name: FDA Drugs

FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Investigation Linked to ByHeart Infant Formula

The U.S. Food and Drug Administration today reminded industry of its legal responsibilities under the Federal Food, Drug, and Cosmetic Act regarding food recalls and called for industry to increase adoption of best practices in recall implementation

Published: Dec 15, 2025 | Category: FDA | Name: FDA Press Release

FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer

On December 15, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-a

Published: Dec 15, 2025 | Category: FDA | Name: FDA Drugs

FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews

The U.S. Food and Drug Administration (FDA) today removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications reviews.

Published: Dec 15, 2025 | Category: FDA | Name: FDA Press Release

Zoliflodacin - Oral Products

Published: Dec 15, 2025 | Category: FDA | Name: FDA Drugs

Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs

This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of a representative population in their clinical trials.

Published: Dec 15, 2025 | Category: FDA | Name: FDA Drugs

Environmental Impact Review at CDER

OPS Environmental Impact Review at CDER: ENVIRONMENTAL IMPACT: CLAIMS FOR CATEGORICAL EXCLUSION

Published: Dec 15, 2025 | Category: FDA | Name: FDA Drugs

FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results

The U.S. Food and Drug Administration today awarded a national priority voucher to teclistamab in combination with daratumumab for relapsed/refractory multiple myeloma.

Published: Dec 15, 2025 | Category: FDA | Name: FDA Press Release

Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies

Published: Dec 15, 2025 | Category: FDA | Name: FDA Drugs

Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices

Drug Safety

Published: Dec 15, 2025 | Category: FDA | Name: FDA Drugs

Examples of Accepted Emerging Technologies

CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.

Published: Dec 12, 2025 | Category: FDA | Name: FDA Drugs

How to Participate in Emerging Technology Program (ETP)

CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.

Published: Dec 12, 2025 | Category: FDA | Name: FDA Drugs

Advanced Manufacturing Research Facility (AMRF)

CDER's Advanced Manufacturing Research Facility (AMRF) is a state-of-the-art lab dedicated to evaluating and advancing innovative drug manufacturing technologies, ensuring drug safety, effectiveness, and quality, and supporting the development of industry policies and regulatory frameworks.

Published: Dec 12, 2025 | Category: FDA | Name: FDA Drugs

Inspection | Enforcement Resources

Inspection/Enforcement Resources

Published: Dec 12, 2025 | Category: FDA | Name: FDA Drugs

What is a Botanical Drug?

A botanical drug product is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans. The CDER Botanical Review Team (BRT) has scientific expertise on a wide range of botanical issues. Learn more.

Published: Dec 12, 2025 | Category: FDA | Name: FDA Drugs

Quality Metrics for Drug Manufacturing

Quality Metrics Data Reporting: This program will help FDA to address common quality issues in the pharmaceutical industry, address product shortage issues, and encourage modernization of pharmaceutical manufacturing.

Published: Dec 12, 2025 | Category: FDA | Name: FDA Drugs

Drug Master Files (DMFs)

Info helps to master FDA’s list of Drug Master Files (DMFs) and info on submission of DMFs to agency. FDA provides info on DMF list, status of DMF, types of DMF, and more.

Published: Dec 12, 2025 | Category: FDA | Name: FDA Drugs

Lifecycle of an Emerging Technology Program (ETP)

CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.

Published: Dec 12, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves Two Oral Therapies to Treat Gonorrhea

The U.S. Food and Drug Administration recently approved two new oral medicines to treat a common sexually transmitted infection called gonorrhea.

Published: Dec 12, 2025 | Category: FDA | Name: FDA Press Release

Catalent Indiana, LLC - 718189 - 11/20/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Dec 11, 2025 | Category: FDA | Name: FDA Drugs

FDA Proposes Expanding Sunscreen Active Ingredient List

Today, the U.S. Food and Drug Administration announced that it is taking action to advance sunscreen innovation, part of a broader initiative in the Office of Nonprescription Drugs. The agency is proposing to add bemotrizinol as a permitted active ingredient for use in sunscreens.

Published: Dec 11, 2025 | Category: FDA | Name: FDA Press Release

MediNatura New Mexico, Inc. Issues Voluntary Nationwide Recall of ReBoost Nasal Spray Due to Microbial Contamination

FOR IMMEDIATE RELEASE – December 10, 2025 – Albuquerque, New Mexico, MediNatura New Mexico, Inc. is voluntarily recalling one lot of ReBoost Nasal Spray to the consumer level. The product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter, a

Published: Dec 10, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves First Gene Therapy Treatment for Wiskott-Aldrich Syndrome

The U.S. Food and Drug Administration today approved Waskyra (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS).

Published: Dec 9, 2025 | Category: FDA | Name: FDA Press Release

ALYGLO

Indicated for the treatment of primary humoral immunodeficiency (PI) in adults.

Published: Dec 9, 2025 | Category: FDA | Name: FDA Biologics

First Approval in Commissioner's National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity

The U.S. Food and Drug Administration today approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher (CNPV) pilot program, marking the first approval achieved through this review pathway.

Published: Dec 9, 2025 | Category: FDA | Name: FDA Press Release

Immune Globulins

Lists of immune globulins fractionated plasma products blood.

Published: Dec 9, 2025 | Category: FDA | Name: FDA Biologics

Seaway Pharma Inc. - 717355 - 12/01/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Dec 9, 2025 | Category: FDA | Name: FDA Drugs

BioXtek LLC - 715478 - 12/01/2025

Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)

Published: Dec 9, 2025 | Category: FDA | Name: FDA Biologics

Lux Therapeutics LLC dba Ponya Therapeutics LLC - 720001 - 11/25/2025

Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)

Published: Dec 9, 2025 | Category: FDA | Name: FDA Biologics

Celularity, Inc - 681480 - 12/01/2025

Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)

Published: Dec 9, 2025 | Category: FDA | Name: FDA Biologics

CDL Services, Inc. DBA Technichem - 713877 - 11/24/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Dec 9, 2025 | Category: FDA | Name: FDA Drugs

DeVere Manufacturing Inc. - 715846 - 11/12/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Dec 9, 2025 | Category: FDA | Name: FDA Drugs

Prescription-to-Nonprescription (Rx-to-OTC) Switches

A sponsor of a nonprescription drug product may seek to market a prescription drug product as nonprescription.

Published: Dec 9, 2025 | Category: FDA | Name: FDA Drugs

Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers

The guidance addresses questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements for prescription reference products, biosimilar products, and interchangeable biosimilar products.

Published: Dec 9, 2025 | Category: FDA | Name: FDA Drugs

FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants

FDA approved and authorized for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19.

Published: Dec 9, 2025 | Category: FDA | Name: FDA Biologics

FDA Roundup: May 31, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Dec 9, 2025 | Category: FDA | Name: FDA Drugs

FDA Roundup: March 12, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Dec 9, 2025 | Category: FDA | Name: FDA Drugs

FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval

The FDA converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit.

Published: Dec 9, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes

The FDA approved two medicines as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes. These approvals provide a new class of medicines taken by mouth to treat pediatric type 2 diabetes.

Published: Dec 9, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves First COVID-19 Vaccine

FDA approved the first COVID-19 vaccine, which has been known as the Pfizer-BioNTech COVID-19 Vaccine, and is now marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.

Published: Dec 9, 2025 | Category: FDA | Name: FDA Biologics

FDA Approves First Generic Estradiol Vaginal Insert for Treatment of Moderate to Severe Dyspareunia

The U.S. Food and Drug Administration today approved the first generic version of Imvexxy® (estradiol vaginal inserts). This approval will provide women additional options for access to treatment of moderate to severe dyspareunia (painful sexual intercourse), a symptom of vulvar and vaginal atrophy,

Published: Dec 8, 2025 | Category: FDA | Name: FDA Drugs

FDA Qualifies First AI Drug Development Tool, Will Be Used in 'MASH' Clinical Trials

FDA has qualified the first AI drug development tool, the AI-Based Histologic Measurement of NASH (AIM-NASH), to help pathologists assess Metabolic dysfunction Associated Steatohepatitis (MASH) disease activity in clinical trials.

Published: Dec 8, 2025 | Category: FDA | Name: FDA Drugs

OMISIRGE

Indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

Published: Dec 8, 2025 | Category: FDA | Name: FDA Biologics

FDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic Anemia

The U.S. Food and Drug Administration today announced it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA).

Published: Dec 8, 2025 | Category: FDA | Name: FDA Press Release

Generic Drugs Program Fiscal Year 2025 Activities Report

As outlined in the GDUFA III Commitment Letter, these performance metrics must be reported each fiscal year.

Published: Dec 8, 2025 | Category: FDA | Name: FDA Drugs

FDA Launches TEMPO: A First-of-Its-Kind Digital Health Pilot to Expand Access to Chronic Disease Technologies

The U.S. Food and Drug Administration today announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary pilot designed to promote access to certain digital health devices while safeguarding patient safety.

Published: Dec 5, 2025 | Category: FDA | Name: FDA Press Release

INTERCEPT Blood System for Platelets

•Intended to be used for ex vivo preparation of apheresis platelet components in order to reduce the risk of transfusion-transmitted infection (TTI) including sepsis, and to potentially reduce the risk of transfusion-associated graft versus host disease (TA-GVHD).

Published: Dec 5, 2025 | Category: FDA | Name: FDA Biologics

FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma

On December 4, 2025, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company) for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy.

Published: Dec 4, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves First CAR T-Cell Therapy for Marginal Zone Lymphoma In the US

The U.S. Food and Drug Administration today approved a new indication for Breyanzi (Lisocabtagene maraleucel) as the first Chimeric Antigen Receptor (CAR) T-cell therapy in the U.S.

Published: Dec 4, 2025 | Category: FDA | Name: FDA Press Release

Drug Trials Snapshot: LYNOZYFIC

LYNOZYFIC is a bispecific antibody used to treat a type of cancer called multiple myeloma. Learn more about the drug trials.

Published: Dec 4, 2025 | Category: FDA | Name: FDA Drugs

Public Meeting: FDA Rare Disease Day 2026 - 02/23/2026

FDA will host Rare Disease Day, a virtual public meeting, on Monday, February 23, 2026 in global observance of Rare Disease Week. The theme is: “Moving Forward. Looking Ahead. An Event for Patients.” The goal of this year’s RDD is to explore ways to engage and collaborate with patients and their communities to support and accelerate the development

Published: Dec 4, 2025 | Category: FDA | Name: FDA Biologics

FDA Conditionally Approves Topical Drug for Cattle for New World Screwworm and Cattle Fever Tick

Today, the U.S. Food and Drug Administration conditionally approved Exzolt Cattle-CA1 (fluralaner) topical solution for the prevention and treatment of New World screwworm (NWS) larval infestations, and the treatment and control of cattle fever tick in beef cattle 2 months of age and older and repl

Published: Dec 4, 2025 | Category: FDA | Name: FDA Press Release

FDA Announces Leadership Appointments at Center for Drug Evaluation and Research

The U.S. Food and Drug Administration (FDA) today announced that Tracy Beth Høeg, M.D., Ph.D., has been appointed acting director of the Center for Drug Evaluation and Research (CDER).

Published: Dec 3, 2025 | Category: FDA | Name: FDA Press Release

FDA Approves Nerve Scaffold for the Treatment of Sensory Nerve Discontinuity

The U.S. Food and Drug Administration today granted approval for Avance (acellular nerve allograft-arwx) in surgical implantation.

Published: Dec 3, 2025 | Category: FDA | Name: FDA Press Release

FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma

On December 3, 2025, the Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Published: Dec 3, 2025 | Category: FDA | Name: FDA Drugs

What are the Qualifications and Requirements of RDRC Membership?

Criteria to be met by members of Radioactive Drug Research Committees

Published: Dec 3, 2025 | Category: FDA | Name: FDA Drugs

What Information Does the RDRC Review?

Determining if basic research proposals meet requirements

Published: Dec 3, 2025 | Category: FDA | Name: FDA Drugs

CBER-Regulated Products: Shortages and Discontinuations

A CBER-regulated product shortage occurs when a CBER-regulated product is not commercially available in sufficient quantity to meet the demand.

Published: Dec 3, 2025 | Category: FDA | Name: FDA Biologics

eCopy Program for Medical Device Submissions

This guidance provides, among other things, the standards for a valid eCopy under section 745A(b)(2)(A) of the FD&C Act.

Published: Dec 3, 2025 | Category: FDA | Name: FDA Biologics

FDA Seizes 7-OH Opioids to Protect American Consumers

The U.S. Food and Drug Administration, in coordination with the U.S. Department of Justice, announced today that the U.S. Marshals Service seized approximately 73,000 units of 7-hydroxymitragynine (7-OH) products—valued at roughly $1 million—from three firms in Missouri.

Published: Dec 2, 2025 | Category: FDA | Name: FDA Press Release

FDA warns about heavy metal poisoning associated with certain unapproved ayurvedic drug products

Use of unapproved ayurvedic drug products containing harmful levels of heavy metals may cause heavy metal poisoning

Published: Dec 2, 2025 | Category: FDA | Name: FDA Drugs

Certain bodybuilding products put consumers at risk for heart attack, stroke, serious liver damage and more

FDA continues to warn consumers about bodybuilding products labeled to contain steroid and steroid-like substances.

Published: Dec 2, 2025 | Category: FDA | Name: FDA Drugs

Fraudulent Products

Consumers should avoid products marketed as supplements or other types of products that claim to have effects similar to prescription drugs.

Published: Dec 2, 2025 | Category: FDA | Name: FDA Drugs

FDA Grand Rounds – Advancing Real-World Evidence in FDA Regulatory Decision Making - 12/11/2025

Advancing Real-World Evidence in FDA Regulatory Decision Making

Published: Dec 2, 2025 | Category: FDA | Name: FDA Biologics

FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal Antibodies

Today, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining specific product types for which the FDA believes six-month non-human primate toxicity testing can be eliminated or reduced.

Published: Dec 2, 2025 | Category: FDA | Name: FDA Press Release

Turbare Manufacturing - 713516 - 09/16/2025

Compounding Pharmacy/Adulterated Drug Products

Published: Dec 2, 2025 | Category: FDA | Name: FDA Drugs

PQ Pharmacy, LLC - 715795 - 10/10/2025

Compounding Pharmacy/Adulterated Drug Products

Published: Dec 2, 2025 | Category: FDA | Name: FDA Drugs

Rhyz Analytical Labs - 715298 - 11/12/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Dec 2, 2025 | Category: FDA | Name: FDA Drugs

QTc Information in Human Prescription Drug and Biological Product Labeling

QTc Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry

Published: Dec 2, 2025 | Category: FDA | Name: FDA Drugs

Monoclonal Antibodies: Streamlined Nonclinical Safety Studies

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Monoclonal Antibodies: Streamlined Nonclinical Safety Studies.”

Published: Dec 2, 2025 | Category: FDA | Name: FDA Drugs

FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment

The U.S. Food and Drug Administration today announced the deployment of agentic AI capabilities for all agency employees.

Published: Dec 1, 2025 | Category: FDA | Name: FDA Press Release

FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease

The FDA granted supplemental approval to Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.

Published: Dec 1, 2025 | Category: FDA | Name: FDA Drugs

Coronavirus (COVID-19) Update: FDA Authorizes Bivalent Pfizer-BioNTech COVID-19 Vaccine as Booster Dose for Certain Children 6 Months through 4 Years of Age

The FDA amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent Pfizer-BioNTech COVID-

Published: Dec 1, 2025 | Category: FDA | Name: FDA Biologics

Medical Gases — Current Good Manufacturing Practice

Pharmaceutical Quality/Manufacturing Standards (CGMP)

Published: Dec 1, 2025 | Category: FDA | Name: FDA Drugs

Q3E Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs

Published: Dec 1, 2025 | Category: FDA | Name: FDA Drugs

QE3 Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs

Published: Nov 28, 2025 | Category: FDA | Name: FDA Drugs

Q3E Guideline for Extractables and Leachables

Published: Nov 28, 2025 | Category: FDA | Name: FDA Drugs

Current Good Manufacturing Practice for Medical Gases

Pharmaceutical Quality/Manufacturing Standards (CGMP)

Published: Nov 28, 2025 | Category: FDA | Name: FDA Drugs

ITVISMA

For the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in survival motor neuron 1 (SMN1) gene.

Published: Nov 26, 2025 | Category: FDA | Name: FDA Biologics

Approved Cellular and Gene Therapy Products

Listing of licensed and approved products from the Office of Therapeutic Products (OTP).

Published: Nov 26, 2025 | Category: FDA | Name: FDA Biologics

FDA approves a new treatment for primary immunoglobulin A nephropathy

Published: Nov 25, 2025 | Category: FDA | Name: FDA Drugs

FDA approves durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma

Published: Nov 25, 2025 | Category: FDA | Name: FDA Drugs

BK251174- FastSkin Patch

The FastSkin® Patch is intended to be used at the point of care for the safe and rapid preparation of Whole Blood Clot (WBC) from a small sample of a patient's own peripheral blood.

Published: Nov 25, 2025 | Category: FDA | Name: FDA Biologics

Educational Resources

Published: Nov 25, 2025 | Category: FDA | Name: FDA Drugs

Blood Grouping Regents, BL 101728-34;103292; 125848-125855

Blood Grouping Regents, BL 101728-34;103292; 125848-125855 Reagent is used for testing human red blood cells by the room temperature saline tube test

Published: Nov 25, 2025 | Category: FDA | Name: FDA Biologics

Wells Pharma of Houston, LLC - 713015 - 11/07/2025

Compounding Pharmacy/Adulterated Drug Products

Published: Nov 25, 2025 | Category: FDA | Name: FDA Drugs

Mahita LLC dba PushMyCart - 716286 - 11/17/2025

Unapproved New Drugs

Published: Nov 25, 2025 | Category: FDA | Name: FDA Drugs

Handelnine Global, LLC dba Navafresh - 716013 - 11/17/2025

Unapproved New Drugs/Adulterated/Misbranded

Published: Nov 25, 2025 | Category: FDA | Name: FDA Drugs

Swift Digital Group LLC dba Swadesii - 716644 - 11/17/2025

Unapproved New Drugs

Published: Nov 25, 2025 | Category: FDA | Name: FDA Drugs

Distacart Inc. - 716212 - 11/17/2025

Unapproved New Drugs

Published: Nov 25, 2025 | Category: FDA | Name: FDA Drugs

VarunKart Group LLC dba Organic Wellnesses - 716154 - 11/17/2025

Unapproved New Drugs

Published: Nov 25, 2025 | Category: FDA | Name: FDA Drugs

Owen Biosciences, Inc. - 710275 - 10/30/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Nov 25, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves Reformulated Ranitidine Following Comprehensive Safety Review

Today, the U.S. Food and Drug Administration approved reformulated ranitidine tablets, marking the return of this important acid-reducing medication to the U.S. market after a five-year absence. The approval follows extensive safety testing and manufacturing improvements that address previous concer

Published: Nov 25, 2025 | Category: FDA | Name: FDA Drugs

Northern VA Compounders PLLC, dba Akina Pharmacy - 671700 - 04/12/2024

Compounding Pharmacy/Adulterated Drug Products

Published: Nov 24, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves Gene Therapy for Treatment of Spinal Muscular Atrophy

The U.S. Food and Drug Administration today approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in the survival motor neuron 1 (SMN1) gene.

Published: Nov 24, 2025 | Category: FDA | Name: FDA Press Release

Generic Drugs Program Activities Report - FY 2025 Monthly Performance

This report provides monthly activities metrics for the FDA Generic Drugs Program, outlining agency actions on abbreviated new drug applications. Data includes approvals, applications received, complete responses, and more.

Published: Nov 24, 2025 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: BRINSUPRI

Published: Nov 24, 2025 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: ZEGFROVY

Published: Nov 24, 2025 | Category: FDA | Name: FDA Drugs

Q&A on CGMP Requirements

Pharmaceutical Quality/Manufacturing Standards (CGMP)

Published: Nov 21, 2025 | Category: FDA | Name: FDA Drugs

mR.7 SUPER 700000 may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use mR.7 SUPER 700000

Published: Nov 21, 2025 | Category: FDA | Name: FDA Drugs

FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer

On November 21, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for.

Published: Nov 21, 2025 | Category: FDA | Name: FDA Drugs

A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium - 02/13/2024

A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium

Published: Nov 21, 2025 | Category: FDA | Name: FDA Drugs

Expiration Dates - Questions and Answers

Pharmaceutical Quality Resources Expiration Dates - Questions and Answers

Published: Nov 21, 2025 | Category: FDA | Name: FDA Drugs

Questions and Answers on Quality-Related Controlled Correspondence

Published: Nov 21, 2025 | Category: FDA | Name: FDA Drugs

Pediatric Tracking Requirements Under FDAAA

Dissemination of pediatric information resulting from pediatric studies done pursuant to FDAAA

Published: Nov 20, 2025 | Category: FDA | Name: FDA Drugs

Executive Order 14017 on America’s Supply Chains

Updates on recommendations to help shore up the U.S. pharmaceutical supply chain, as directed by Executive Order 14017 on America’s Supply Chains

Published: Nov 20, 2025 | Category: FDA | Name: FDA Drugs

FDA Pilots Faster Clarifications to Meeting Minutes

The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal meetings.

Published: Nov 19, 2025 | Category: FDA | Name: FDA Press Release

FDALabel: Full-Text Search of Drug Product Labeling

FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 150,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices.

Published: Nov 19, 2025 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: MODEYSO

Published: Nov 19, 2025 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: ANZUPGO

Published: Nov 19, 2025 | Category: FDA | Name: FDA Drugs

FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer

On November 19, 2025, the Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated appro

Published: Nov 19, 2025 | Category: FDA | Name: FDA Drugs

FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer

On November 19, 2025, the Food and Drug Administration granted accelerated approval to sevabertinib.

Published: Nov 19, 2025 | Category: FDA | Name: FDA Drugs

Questions and Answers: FDA posts deemed final order and proposed order for over-the-counter sunscreen

The following questions and answers provide more information on the deemed final order and proposed order.

Published: Nov 19, 2025 | Category: FDA | Name: FDA Drugs

FDA grants traditional approval to daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis

On November 19, 2025, the Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated appro

Published: Nov 19, 2025 | Category: FDA | Name: FDA Drugs

FDA Modernizes Clinical Trials with Master Protocols

"FDA Modernizes Clinical Trials with Master Protocols" February 26, 2019 Issue

Published: Nov 19, 2025 | Category: FDA | Name: FDA Drugs

CDER SBIA Chronicles

FDA/CDER SBIA Chronicles, the bi-monthly newsletter of the CDER Small Business and Industry Assistance team, provides industry with useful information to assist in all aspects of drug marketing and regulation

Published: Nov 18, 2025 | Category: FDA | Name: FDA Drugs

Public Posting of a Comprehensive Surrogate Endpoint Table for CDER- and CBER-Regulated Products

The public posting of a surrogate endpoint table for both reasonably likely and validated surrogate endpoints was mandated by the 21st Century Cures Act. The surrogate endpoint table increases transparency by informing stakeholders about the development of novel surrogate endpoints.

Published: Nov 18, 2025 | Category: FDA | Name: FDA Drugs

FDA and MHRA Good Clinical Practice Symposium: Data Integrity in Global Clinical Trials - Tackling Challenging Topics in 2020: 02/13/2020 - 02/14/2020

The 2020 symposium will provide regulatory perspectives on the importance of sponsor oversight of clinical sites and laboratories, eSource including electronic health records, protocol deviations including the impact on clinical trials and the challenges in ensuring data quality in novel clinical tr

Published: Nov 18, 2025 | Category: FDA | Name: FDA Drugs

FDA Drug Competition Action Plan

FDA's Drug Competition Action Plan (DCAP) encourages robust and timely market competition for generic drugs and helps bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program.

Published: Nov 18, 2025 | Category: FDA | Name: FDA Drugs

Regulatory Education for Industry: 2019 Complex Generic Drug Product Development Workshop – Sep. 25-26, 2019 - 09/25/2019

As a continuation from the 2018 workshop on complex generic drug products, this science-focused workshop communicates to the generic industry how FDA research outcomes guide and facilitate complex generic drug product development.

Published: Nov 18, 2025 | Category: FDA | Name: FDA Drugs

FDA Drug Competition Action Plan | Maximizing scientific and regulatory clarity with respect to complex generic drugs

Complex generic products are typically harder to develop, which means that many complex products face less competition than other products, and therefore can be more expensive and less accessible to the patients who need them.

Published: Nov 18, 2025 | Category: FDA | Name: FDA Drugs

National Drug Code Database Background Information

Published: Nov 18, 2025 | Category: FDA | Name: FDA Drugs

FDA approves drug to reduce triglycerides in adults with familial chylomicronemia syndrome

Published: Nov 18, 2025 | Category: FDA | Name: FDA Drugs

FDA approves epcoritamab-bysp for follicular lymphoma indications

Published: Nov 18, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause

The FDA approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first neurokinin 3 receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause.

Published: Nov 18, 2025 | Category: FDA | Name: FDA Drugs

Verdure Sciences, Inc. - 717259 - 11/10/2025

Sponsor/Investigator

Published: Nov 18, 2025 | Category: FDA | Name: FDA Drugs

Medical Mega - 717840 - 11/13/2025

Nonprescription/OTC

Published: Nov 18, 2025 | Category: FDA | Name: FDA Drugs

Save Rite Medical - 717838 - 11/13/2025

Nonprescription/OTC

Published: Nov 18, 2025 | Category: FDA | Name: FDA Drugs

Shoplet - 717846 - 11/13/2025

Nonprescription/OTC

Published: Nov 18, 2025 | Category: FDA | Name: FDA Drugs

Cdymax India Pharma Private Limited - 715022 - 11/13/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Nov 18, 2025 | Category: FDA | Name: FDA Drugs

Apitoria Pharma Private Limited Unit 1 - 618091 - 11/13/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Nov 17, 2025 | Category: FDA | Name: FDA Drugs

Aurobindo Pharmaceutical Limited - 618091 - 01/12/2022

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Nov 17, 2025 | Category: FDA | Name: FDA Drugs

Generic Competition and Drug Prices

FDA report demonstrating greater competition among generic drug makers can lead to lower generic drug prices.

Published: Nov 17, 2025 | Category: FDA | Name: FDA Drugs

FDA Takes Action on New Boxed Warning for Acute Serious Liver Injury and Acute Liver Failure Following Treatment with Elevidys and Revised Indication that is Limited to Ambulatory Duchenne Muscular Dystrophy Patients

In June 2025, FDA issued a safety communication, “FDA Investigating Deaths Due to Acute Liver Failure in Non-ambulatory Duchenne Muscular Dystrophy Patients Following ELEVIDYS,” to provide information on two reports of fatal acute liver failure following treatment with Elevidys...

Published: Nov 14, 2025 | Category: FDA | Name: FDA Biologics

FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury

The U.S. Food and Drug Administration today announced it is taking action to approve new labeling submitted by the company that includes the addition of a Boxed Warning, the agency’s most prominent safety warning, to Elevidys (delandistrogene moxeparvovec-rokl), and that the indication section of th

Published: Nov 14, 2025 | Category: FDA | Name: FDA Press Release

Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use

Published: Nov 14, 2025 | Category: FDA | Name: FDA Drugs

FDA approves first interchangeable biosimilar to Perjeta to treat certain types of breast cancer

FDA approves first interchangeable biosimilar to Perjeta to treat certain types of breast cancer.

Published: Nov 13, 2025 | Category: FDA | Name: FDA Drugs

Electronic Submissions Presentations

List Electronic Submissions Presentations

Published: Nov 13, 2025 | Category: FDA | Name: FDA Drugs

FDA approves new interchangeable biosimilar to Perjeta

On November 13, 2025, the Food and Drug Administration approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc.). This is the first approval of a biosimilar for Perjeta.

Published: Nov 13, 2025 | Category: FDA | Name: FDA Drugs

FDA approves ziftomenib for relapsed or refractory acute myeloid leukemia with a NPM1 mutation

On November 13, 2025, the Food and Drug Administration approved ziftomenib (Komzifti, Kura Oncology, Inc.).

Published: Nov 13, 2025 | Category: FDA | Name: FDA Drugs

Drug Development Considerations for the Treatment of Neonatal Enterovirus Infection and Congenital Cytomegalovirus Infection--Virtual Public Workshop - 05/07/2024

The Food and Drug Administration is holding a public, two-day workshop entitled Development of Drugs for the Treatment of Congenital Cytomegalovirus (CMV) Infection and Neonatal Enterovirus Infection.

Published: Nov 12, 2025 | Category: FDA | Name: FDA Drugs

Longtime FDA Innovator Appointed as Director of Center for Drug Evaluation and Research

The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today announced that Richard Pazdur, M.D., has been appointed director of the Center for Drug Evaluation and Research (CDER). Pazdur is a 26-year veteran of the FDA.

Published: Nov 11, 2025 | Category: FDA | Name: FDA Press Release

Taizhou Kangping Medical Science and Technology Co., Ltd. - 711081 - 10/09/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Nov 11, 2025 | Category: FDA | Name: FDA Drugs

Miers Laboratories, Ltd - 715378 - 11/03/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Nov 11, 2025 | Category: FDA | Name: FDA Drugs

IBSPOT.com Inc. - 715657 - 10/27/2025

Unapproved New Drugs/Misbranded

Published: Nov 11, 2025 | Category: FDA | Name: FDA Drugs

HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy

The U.S. Department of Health and Human Services (HHS) today announced historic action to restore gold-standard science to women’s health.

Published: Nov 10, 2025 | Category: FDA | Name: FDA Press Release

HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy

The U.S. Department of Health and Human Services (HHS) today announced historic action to restore gold-standard science to women’s health.

Published: Nov 10, 2025 | Category: FDA | Name: FDA Press Release

HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy

The U.S. Department of Health and Human Services (HHS) today announced historic action to restore gold-standard science to women’s health.

Published: Nov 10, 2025 | Category: FDA | Name: FDA Press Release

FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies

Proposed removal of risk statements about cardiovascular diseases, breast cancer, and probable dementia from the boxed warnings, as well as other proposed safety-related labeling changes, to clarify the benefit/risk considerations for these drugs.

Published: Nov 10, 2025 | Category: FDA | Name: FDA Drugs

Konrad Rejdak, MD, PhD - 671405 - 05/01/2025

Bioresearch Monitoring Program/IRB

Published: Nov 10, 2025 | Category: FDA | Name: FDA Drugs

Konrad Rejdak, M.D., Ph.D. - 671405 - 05/29/2024

Bioresearch Monitoring Program/IRB  

Published: Nov 10, 2025 | Category: FDA | Name: FDA Biologics

ProQuad

The Approval Letter and Approved Final Draft Labeling for Merck's Efficacy Supplement for Measles, Mumps, Rubella, and Varicella Vaccine, Live, (ProQuad®), to include concomitant administration with hepatitis A vaccine (VAQTA®) and/or pneumococcal conjugate vaccine (Prevnar®), use of ProQuad® in chi

Published: Nov 7, 2025 | Category: FDA | Name: FDA Biologics

Measles, Mumps and Rubella Virus Vaccine Live

Product approval information for the Measles, Mumps, and Rubella Virus Vaccine, Live also known as M-M-R II.

Published: Nov 7, 2025 | Category: FDA | Name: FDA Biologics

Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples

FOR IMMEDIATE RELEASE – Nov. 6,2025 – LAKE ZURICH, Ill.— Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mg

Published: Nov 7, 2025 | Category: FDA | Name: FDA Drugs

Elecsys HTLV-I/II

The Elecsys HTLV-I/II is an in vitro immunoassay for the qualitative detection of antibodies to HTLV-I and HTLV-II in human serum and plasma. Elecsys HTLV-I/II is intended to screen individual human donors, including volunteer donors of whole blood and blood components.

Published: Nov 7, 2025 | Category: FDA | Name: FDA Biologics

FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myeloma

On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adults with high-risk smoldering multiple myeloma (SMM).

Published: Nov 6, 2025 | Category: FDA | Name: FDA Drugs

FDA Awards Second Batch of National Priority Vouchers

The U.S. Food and Drug Administration today announced six additional awardees under the Commissioner’s National Priority Voucher (CNPV) pilot program.

Published: Nov 6, 2025 | Category: FDA | Name: FDA Press Release

CYFENDUS

For use as a post-exposure prophylactic vaccine following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial regimen.

Published: Nov 6, 2025 | Category: FDA | Name: FDA Biologics

BioThrax

BioThrax is indicated for the active immunization for the prevention of disease caused by Bacillus anthracis in persons 18 through 65 years of age.

Published: Nov 6, 2025 | Category: FDA | Name: FDA Biologics

How to Prepare a Pre-Request for Designation (Pre-RFD)

Guidance for Industry: How to Prepare a Pre-Request for Designation (Pre-RFD)

Published: Nov 6, 2025 | Category: FDA | Name: FDA Drugs

FDA approves 1st drug for children 7 years and older with irritable bowel syndrome with constipation

Published: Nov 6, 2025 | Category: FDA | Name: FDA Drugs

FDA Warns Companies Over Illegal Marketing of Botox and Related Products

The U.S. Food and Drug Administration issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox.

Published: Nov 5, 2025 | Category: FDA | Name: FDA Press Release

Glowface - 11/03/2025

Unapproved New Drugs/Misbranded/Botox

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

Derma Solution - 11/03/2025

Unapproved New Drugs/Misbranded/Botox

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

MJS Medicals - 11/03/2025

Unapproved New Drugs/Misbranded/Botox

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

Meamo - 11/03/2025

Unapproved New Drugs/Misbranded/Botox

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

Glam Derma - 11/03/2025

Unapproved New Drugs/Misbranded/Botox

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

COSMO KOREA - 11/03/2025

Unapproved New Drugs/Misbranded/Botox

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

CelestaPro - 718613 - 11/03/2025

Unapproved New Drugs/Misbranded Botox

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

Korean Aesthetic dba Korean Fillers - 718842 - 11/03/2025

Unapproved New Drugs/Misbranded Botox

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

Estaderma - 718714 - 11/03/2025

Unapproved New Drugs/Misbranded Botox

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

Maypharm - 718717 - 11/03/2025

Unapproved New Drugs/Misbranded Botox

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

Korean Aesthetic dba Korean Fillers - 718842 - 11/03/2025

Unapproved New Drugs/Misbranded/Botox Blitz

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

Elle Pharm - 718713 - 11/03/2025

Unapproved New Drugs/Misbranded/Botox Blitz

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

Cosmenic - 718621 - 11/03/2025

Unapproved New Drugs/Misbranded Botox

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

Dermacare dba Filler Outlet - 718715 - 11/03/2025

Unapproved New Drugs/Misbranded Botox

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

Aesthetic Essentials Limited - 718707 - 11/03/2025

Unapproved New Drugs/Misbranded/Botox Blitz

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

Glow Nest Beauty - 718710 - 11/03/2025

Unapproved New Drugs/Misbranded/Botox Blitz

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

Dermax Co., Ltd - 718712 - 11/03/2025

Unapproved New Drugs/Misbranded/Botox Blitz

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

AceCosm - 718610 - 11/03/2025

Unapproved New Drugs/Misbranded/Botox Blitz

Published: Nov 5, 2025 | Category: FDA | Name: FDA Drugs

onlineotcmeds.com - 717697 - 10/15/2025

Unapproved New Drugs/Misbranded

Published: Nov 4, 2025 | Category: FDA | Name: FDA Drugs

Scientific Protein Laboratories, LLC - 712578 - 10/10/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Nov 4, 2025 | Category: FDA | Name: FDA Drugs

Apotex Inc. - 714137 - 10/31/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Nov 4, 2025 | Category: FDA | Name: FDA Drugs

Kath Khemicals LLC - 711699 - 09/22/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Nov 4, 2025 | Category: FDA | Name: FDA Drugs

Liebel-Flarsheim Company LLC - 711508 - 10/17/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Nov 4, 2025 | Category: FDA | Name: FDA Drugs

Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine - 12/16/2025

This one-day hybrid (virtual and in person) workshop will initiate a discussion on expanding epinephrine accessibility and use, including in community settings, to reduce anaphylaxis-related morbidity and mortality. This public workshop is convened by FDA and the Duke-Margolis Institute for Health Policy.

Published: Nov 3, 2025 | Category: FDA | Name: FDA Drugs

Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

FOR IMMEDIATE RELEASE – October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product

Published: Nov 3, 2025 | Category: FDA | Name: FDA Drugs

FDA approves 1st drug for thymidine kinase 2 deficiency, a very rare mitochondrial disease

Published: Nov 3, 2025 | Category: FDA | Name: FDA Drugs

Quit Kit, LLC - Online Advisory Letter

Published: Nov 3, 2025 | Category: FDA | Name: FDA Drugs

BsUFA IV: Fiscal Years 2028-2032

On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022.

Published: Nov 3, 2025 | Category: FDA | Name: FDA Drugs

Public Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA) - 12/03/2025

FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2028 through 2032. The public meeting will be held on December 3, 2025, from 9 a.m. to 12 p.m ET.

Published: Nov 3, 2025 | Category: FDA | Name: FDA Biologics

Ingestible Fluoride Drug Products

FDA recommends that ingestible fluoride drug products – typically available as tablets and drops – should be limited to children aged three years and older who are at high risk for tooth decay.

Published: Oct 31, 2025 | Category: FDA | Name: FDA Drugs

FDA Acts to Protect Children from Unapproved Fluoride Drug Products

The U.S. Food and Drug Administration today announced actions to restrict the sale of unapproved ingestible fluoride prescription drug products for children.

Published: Oct 31, 2025 | Category: FDA | Name: FDA Press Release

Postmarketing Requirements and Commitments: Searchable Database

Learn more about FDA's Postmarketing Requirements and Commitments Searchable Database.

Published: Oct 31, 2025 | Category: FDA | Name: FDA Drugs

Joint US FDA – Health Canada ICH Public Meeting - 02/22/2024

Joint US FDA – Health Canada ICH Public Meeting

Published: Oct 30, 2025 | Category: FDA | Name: FDA Drugs

Biologics Procedures (SOPPs)

These Standard Operating Procedures and Policies (SOPPs) are used by staff in FDA's Center for Biologics Research and Review (CBER) in the performance of their duties. They are made available here to the public because CBER is committed to being as transparent as possible in how it operates.

Published: Oct 29, 2025 | Category: FDA | Name: FDA Biologics

FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs

The U.S. Food and Drug Administration (FDA) today announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost “generic” alternatives to biologic drugs that treat serious and chronic diseases.

Published: Oct 29, 2025 | Category: FDA | Name: FDA Press Release

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies

This draft guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints (a comparative efficacy study or CES) intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product.

Published: Oct 29, 2025 | Category: FDA | Name: FDA Drugs

CANCELED - 17th Annual Sentinel Initiative Public Workshop - 11/06/2025

The U.S. Food and Drug Administration, under a cooperative agreement with the Duke-Margolis Institute for Health Policy, is hosting the 16th Annual Sentinel Initiative Public Workshop on November 6, 2025

Published: Oct 29, 2025 | Category: FDA | Name: FDA Drugs

POSTPONED - 17th Annual Sentinel Initiative Public Workshop - 11/06/2025

Published: Oct 28, 2025 | Category: FDA | Name: FDA Drugs

The Tranzonic Companies/Innocore Sales & Marketing Inc. - 712258 - 10/16/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Oct 28, 2025 | Category: FDA | Name: FDA Drugs

Pediatrics and Maternal Health

DPMH oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population and to improve pregnancy and lactation-related information in product labeling.

Published: Oct 28, 2025 | Category: FDA | Name: FDA Drugs

Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development - 05/29/2024

Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development

Published: Oct 27, 2025 | Category: FDA | Name: FDA Drugs

Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling

Endo, Inc. (OTCQX: NDOI) (“Endo”) announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling.

Published: Oct 27, 2025 | Category: FDA | Name: FDA Drugs

FDA Issues Emergency Use Authorization for New World Screwworm Drug for Dogs

FDA issued an Emergency Use Authorization (EUA) concluding that based on the scientific evidence available, Credelio (lotilaner) chewable tablets may be effective in treating New World screwworm (NWS) infestations in dogs and puppies.

Published: Oct 24, 2025 | Category: FDA | Name: FDA Press Release

Vaccines and Related Biological Products Advisory Committee June 15, 2023 Meeting Announcement - 06/15/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting June 15, 2023 announcement and meeting materials.

Published: Oct 24, 2025 | Category: FDA | Name: FDA Biologics

FDA approves revumenib for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation

On October 24, 2025, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no sati

Published: Oct 24, 2025 | Category: FDA | Name: FDA Drugs

Naturich Cosmetique Labs - 713565 - 09/25/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Oct 24, 2025 | Category: FDA | Name: FDA Drugs

Expanded Access | Information for Institutional Review Boards (IRBs)

Learn more about what IRBs should consider when reviewing Individual Patient Expanded Access Requests.

Published: Oct 24, 2025 | Category: FDA | Name: FDA Drugs

Expanded Access | Information for Industry

Expanded Access information for medical product companies and other industry stakeholders

Published: Oct 24, 2025 | Category: FDA | Name: FDA Drugs

Expanded Access | Information for Physicians

Expanded Access: Physicians' Page

Published: Oct 24, 2025 | Category: FDA | Name: FDA Drugs

Expanded Access (Compassionate Use) Submission Data

Published: Oct 24, 2025 | Category: FDA | Name: FDA Drugs

Vaccines and Related Biological Products Advisory Committee January 26, 2023 Meeting Announcement - 01/26/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) January 26, 2023 Meeting Announcement and meeting materials.

Published: Oct 24, 2025 | Category: FDA | Name: FDA Biologics

Elecsys Chagas

Elecsys Chagas is an in vitro immunoassay for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi, the causative agent of the Chagas disease) in human serum and plasma. Elecsys Chagas is intended to screen individual human donors, including volunteer donors of whole blood.

Published: Oct 24, 2025 | Category: FDA | Name: FDA Biologics

Infectious Disease Tests

Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Published: Oct 24, 2025 | Category: FDA | Name: FDA Biologics

SPARTAN may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use SPARTAN, a product promoted and sold for male sexual enhancement on various websites, including www.vroxusa.com, and possibly in some retail stores.

Published: Oct 23, 2025 | Category: FDA | Name: FDA Drugs

FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma

On October 23, 2025, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate, with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who

Published: Oct 23, 2025 | Category: FDA | Name: FDA Drugs

2024 First Generic Drug Approvals

Published: Oct 23, 2025 | Category: FDA | Name: FDA Drugs

Drug recall information for consumers, health care professionals and industry

drug recalls page, FDA's role

Published: Oct 23, 2025 | Category: FDA | Name: FDA Drugs

FDA Publishes Filing Checklists to Prevent Submission Delays

The U.S. Food and Drug Administration today made public filing checklists used internally by Center for Drug Evaluation and Research (CDER) staff to determine if a submitted application is complete and reviewable.

Published: Oct 23, 2025 | Category: FDA | Name: FDA Press Release

Fosfomycin Injection

Published: Oct 23, 2025 | Category: FDA | Name: FDA Drugs

FDA Rationale for Recognition Decision: Gentamicin, Tobramycin, and Amikacin for Enterobacterales and P. aeruginosa

FDA has completed its review of the rationale document titled, “Aminoglycoside Breakpoints for Enterobacterales and Pseudomonas aeruginosa” submitted by the Clinical and Laboratory Standards Institute (CLSI) to the public docket FDA-2017-N-5925-0037 in January 2025.

Published: Oct 23, 2025 | Category: FDA | Name: FDA Drugs

Gentamicin – Injection products

Gentamicin – Injection products;

Published: Oct 23, 2025 | Category: FDA | Name: FDA Drugs

Tobramycin – Injection products

Published: Oct 23, 2025 | Category: FDA | Name: FDA Drugs

Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

Published: Oct 22, 2025 | Category: FDA | Name: FDA Drugs

Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments

This guidance is the third in a series of four methodological patient-focused drug development guidances that describe how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers to be used for product development decision-making.

Published: Oct 22, 2025 | Category: FDA | Name: FDA Drugs

Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments

Guidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments

Published: Oct 22, 2025 | Category: FDA | Name: FDA Drugs

CDER International Program

CDER’s work with foreign stakeholders enables progress in the harmonization of scientific and technical standards and regulatory requirements among regulatory authorities.

Published: Oct 22, 2025 | Category: FDA | Name: FDA Drugs

Completed BsUFA II Deliverables

Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review of biosimilar products.

Published: Oct 22, 2025 | Category: FDA | Name: FDA Drugs

Application Submissions Guidances

This page lists Application Submissions Guidance documents.

Published: Oct 21, 2025 | Category: FDA | Name: FDA Biologics

MOLOOCO dba Ourlyard - Online Advisory Letter

Published: Oct 21, 2025 | Category: FDA | Name: FDA Drugs

FDA Provides Update to Health Care Professionals About Risk of Inadvertent Intrathecal (Spinal) Administration of Tranexamic Acid Injection

FDA is requiring labeling changes to strengthen the warnings that tranexamic acid injection should be administered only intravenously (into the vein). Tranexamic acid injection products are not to be administered intrathecally (into the spine) or as an epidural injection. FDA is taking this action a

Published: Oct 21, 2025 | Category: FDA | Name: FDA Drugs

Guangxi Yulin Pharmaceutical Group Co. Ltd. - 710422 - 09/30/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Oct 21, 2025 | Category: FDA | Name: FDA Drugs

Foshan Yiying Hygiene Products Co., Ltd. - 715548 - 10/10/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Oct 21, 2025 | Category: FDA | Name: FDA Drugs

All American Wellness - 715991 - 09/09/2025

Compounding Pharmacy/Misbranded

Published: Oct 21, 2025 | Category: FDA | Name: FDA Drugs

www.usmedschoice.com - 716055 - 10/06/2025

Unapproved New Drugs/Misbranded

Published: Oct 21, 2025 | Category: FDA | Name: FDA Drugs

Acme United Corporation - 712324 - 10/10/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Oct 21, 2025 | Category: FDA | Name: FDA Drugs

BRS Analytical Services, LLC - 711133 - 09/17/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Oct 21, 2025 | Category: FDA | Name: FDA Drugs

Melcare Biomedical Pty Ltd - 717968 - 10/09/2025

Unapproved New Drugs/Misbranded

Published: Oct 21, 2025 | Category: FDA | Name: FDA Drugs

BsUFA III: Fiscal Years 2023-2027

New legislation will be required for FDA to continue collecting biosimilar user fees in future fiscal years. Information related to FDA’s preparation for the third reauthorization of BsUFA will be hosted here on this page as it becomes available.

Published: Oct 20, 2025 | Category: FDA | Name: FDA Drugs

Ashfiat Alharamain Energy Support may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Ashfiat Alharamain Energy Support, a product promoted and sold for male sexual enhancement on various websites, including Amazon.com (Akkarco, LLC storefront), and possibly in some retail stores.

Published: Oct 17, 2025 | Category: FDA | Name: FDA Drugs

Black Thai Honey may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Black Thai Honey, a product promoted and sold for male sexual enhancement on various websites, including www.honeypacks.com, and possibly in some retail stores.

Published: Oct 17, 2025 | Category: FDA | Name: FDA Drugs

Accelerated Approval Program

To allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint

Published: Oct 17, 2025 | Category: FDA | Name: FDA Drugs

FDA Awards First-Ever National Priority Vouchers to Nine Sponsors

The U.S. Food and Drug Administration today announced 9 voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot program.

Published: Oct 16, 2025 | Category: FDA | Name: FDA Press Release

Conducting Clinical Trials With Decentralized Elements

This guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials. Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants.

Published: Oct 16, 2025 | Category: FDA | Name: FDA Drugs

Drug Supply Chain Security Act (DSCSA)

The Drug Quality and Security Act (DQSA) of 2013 -- Law outlines critical steps to build a system to identify and trace certain prescription drugs as they are distributed in the United States. Ten years after enactment, the electronic, interoperable system will facilitate the exchange of information

Published: Oct 16, 2025 | Category: FDA | Name: FDA Drugs

Guidance Snapshot Pilot

Guidance Snapshots are a communication tool that provide highlights from the document using visuals and plain language. This pilot program is intended to increase awareness for FDA guidance documents to support the efficient application of the documents’ recommendations.

Published: Oct 16, 2025 | Category: FDA | Name: FDA Drugs

17th Annual Sentinel Initiative Public Workshop - 11/06/2025

Published: Oct 15, 2025 | Category: FDA | Name: FDA Drugs

ADYNOVATE

Product approval information is indicated for children and adults with hemophilia A (congenital factor VIII deficiency) for: (1) On-demand treatment and control of bleeding episodes; (2) Perioperative management; (3) Routine prophylaxis to reduce the frequency of bleeding episodes.

Published: Oct 15, 2025 | Category: FDA | Name: FDA Biologics

Section 8000: General Information

This is the main page for CBER's SOPP Section 8000: General Information.

Published: Oct 15, 2025 | Category: FDA | Name: FDA Biologics

Section 8500: Compliance

This is the SOPP Section 8500: Compliance main page.

Published: Oct 15, 2025 | Category: FDA | Name: FDA Biologics

2025 Biological License Application Supplement Noteworthy Approvals

Listing of the 2025 Biological License Application Supplement Noteworthy Approvals

Published: Oct 14, 2025 | Category: FDA | Name: FDA Biologics

Whole Blood and Blood Components (Convalescent Plasma, High Titer, Anti-SARS-CoV-2 (Whole Blood-derived)

Treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment

Published: Oct 14, 2025 | Category: FDA | Name: FDA Biologics

Health and Natural Beauty USA Corp. - 700187 - 07/28/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Oct 14, 2025 | Category: FDA | Name: FDA Drugs

Allovate Therapeutics, LLC - 708912 - 09/30/2025

CGMP/Deviations/Biologics License Application (BLA)

Published: Oct 14, 2025 | Category: FDA | Name: FDA Biologics

FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

Published: Oct 10, 2025 | Category: FDA | Name: FDA Biologics

GDUFA III Reauthorization

Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe, effective and high-quality generic drugs. The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the sco

Published: Oct 10, 2025 | Category: FDA | Name: FDA Drugs

GDUFA IV: Fiscal Years 2028 – 2032

Information related to FDA’s preparation for the fourth reauthorization of GDUFA will be hosted on this page as it becomes available.

Published: Oct 10, 2025 | Category: FDA | Name: FDA Drugs

Generic Drugs - Specific Labeling Resources

Published: Oct 10, 2025 | Category: FDA | Name: FDA Drugs

ADSTILADRIN

For the treatment of High-grade, Bacillus Calmette-Guerin (BCG) unresponsive non-muscle invasive bladder cancer.

Published: Oct 10, 2025 | Category: FDA | Name: FDA Biologics

Premarket Approvals and Humanitarian Device Exemptions with Supporting Documents

list includes applications for which we have approval documents available, and reflects the information as of the approval date. It is not updated with regard to applicant or application status changes. Information is arranged in alphabetical order by the name of the applicant.

Published: Oct 10, 2025 | Category: FDA | Name: FDA Biologics

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access - 04/10/2024

Generic Drugs Forum (GDF) 2024&#58; Regulatory Considerations to Enhance Generic Drug Access

Published: Oct 9, 2025 | Category: FDA | Name: FDA Drugs

ROCTAVIAN

Product information for ROCTAVIAN

Published: Oct 8, 2025 | Category: FDA | Name: FDA Biologics

FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma

On October 8, 2025, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

Published: Oct 8, 2025 | Category: FDA | Name: FDA Drugs

Replacing and Reducing Animal Testing at CDER

Published: Oct 8, 2025 | Category: FDA | Name: FDA Drugs

FDA approves drug to treat idiopathic pulmonary fibrosis

Today, the U.S. Food and Drug Administration (FDA) approved Jascayd (nerandomilast) tablets to treat idiopathic pulmonary fibrosis (IPF), a rare, serious, and progressive disease with no cure and limited treatments. This is the first new therapy approved in more than 10 years for IPF.

Published: Oct 7, 2025 | Category: FDA | Name: FDA Drugs

Centura Pharmaceuticals Inc - 684733 - 11/15/2024

Finished Pharmaceuticals/Unapproved New Drug/Misbranded/OTC

Published: Oct 7, 2025 | Category: FDA | Name: FDA Drugs

New Life Medical Services, LLC - 711102 - 09/24/2025

CGMP/Deviations/Biologics License Application (BLA)

Published: Oct 7, 2025 | Category: FDA | Name: FDA Biologics

Mojo Max Fusion XXX may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Mojo Max Fusion XXX, a product promoted and sold for sexual enhancement on various websites, including www.ebay.com, and possibly in some retail stores.

Published: Oct 6, 2025 | Category: FDA | Name: FDA Drugs

Osteo Sin Max may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Osteo Sin Max, a product promoted and sold for joint pain on various websites, including ebay.com, and possibly in some retail stores.

Published: Oct 6, 2025 | Category: FDA | Name: FDA Drugs

Contra Reumas may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Contra Reumas, a product promoted and sold for joint pain on various websites, including naturistarex.com, and possibly in some retail stores.

Published: Oct 3, 2025 | Category: FDA | Name: FDA Drugs

New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation

View details about the NDRP Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation; Request for comments

Published: Oct 3, 2025 | Category: FDA | Name: FDA Drugs

FDA Announces New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing

Published: Oct 3, 2025 | Category: FDA | Name: FDA Drugs

FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer

On October 2, 2025, the Food and Drug Administration approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals, Inc.) in combination with atezolizumab (Tecentriq, Genentech Inc.) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech Inc.).

Published: Oct 2, 2025 | Category: FDA | Name: FDA Drugs

Kuka Flex Forte contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Kuka Flex Forte, a product promoted and sold for joint pain and arthritis on various websites, including https://botanical-be.com, and possibly in some retail stores.

Published: Oct 2, 2025 | Category: FDA | Name: FDA Drugs

ARTISS

Product approval information is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations.

Published: Oct 1, 2025 | Category: FDA | Name: FDA Biologics

TISSEEL

Product approval information is indicated for: •Use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. •An adjunct to sta

Published: Oct 1, 2025 | Category: FDA | Name: FDA Biologics

FDA Encourages Development of New, Reliable Alternatives to Animal Testing in Sunscreen

FDA strongly encourages companies to continue to develop new, reliable ways to minimize animal testing and to provide the data necessary for the FDA to make a GRASE determination for sunscreen active ingredients.

Published: Sep 30, 2025 | Category: FDA | Name: FDA Drugs

FDA Conditionally Approves First Drug for Prevention and Treatment of New World Screwworm Infestations in Cattle

The U.S. Food and Drug Administration conditionally approved Dectomax-CA1 (doramectin injection) injectable solution for the prevention and treatment of New World screwworm larval infestations, and prevention of NWS reinfestation for 21 days.

Published: Sep 30, 2025 | Category: FDA | Name: FDA Press Release

Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes

Use the following list of Biological Product Deviation (BPD) Codes to assign a specific code to a reportable event when you submit the report to FDA. Use the guidance document, "Biological Product Deviation Reporting for Blood and Plasma Establishments," (www.fda.gov/CBER/gdlns/devbld.htm) to determ

Published: Sep 30, 2025 | Category: FDA | Name: FDA Biologics

Biological Product Deviation Reporting -- Blood Product Codes

This is the main page for the Biological Product Deviation Reporting - Blood Product Codes.

Published: Sep 30, 2025 | Category: FDA | Name: FDA Biologics

Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes

This is the main page for the Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes.

Published: Sep 30, 2025 | Category: FDA | Name: FDA Biologics

Pamela K. Den Besten, DDS, MS - 715245 - 09/19/2025

Clinical Investigator (Sponsor) 

Published: Sep 30, 2025 | Category: FDA | Name: FDA Drugs

Ralph A. DeFronzo, M.D. - 716773 - 09/17/2025

Clinical Investigator/Sponsor

Published: Sep 30, 2025 | Category: FDA | Name: FDA Drugs

Me Vale Madre may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Me Vale Madre, a product promoted and sold for migraine and stress pain on various websites, including ebay.com, and possibly in some retail stores.

Published: Sep 30, 2025 | Category: FDA | Name: FDA Drugs

FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA - 09/04/2024

FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA

Published: Sep 30, 2025 | Category: FDA | Name: FDA Drugs

Persōn & Covey, Inc. - 711191 - 09/23/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Sep 30, 2025 | Category: FDA | Name: FDA Drugs

Ogle Cattle Company, Inc. - 713311 - 09/05/2025

New Animal Drug/Adulterated

Published: Sep 30, 2025 | Category: FDA | Name: FDA Drugs

A Statement From FDA Commissioner Marty Makary, M.D., M.P.H.: Encouraging Retailers to Stop Selling Illegal Vapes

As part of the FDA’s broader strategy to combat the crisis of youth vaping, we are launching an initiative to increase voluntary compliance from retailers.

Published: Sep 30, 2025 | Category: FDA | Name: FDA Press Release

April - June 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Published: Sep 30, 2025 | Category: FDA | Name: FDA Drugs

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024 - 09/12/2024

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024

Published: Sep 30, 2025 | Category: FDA | Name: FDA Drugs

Quality and Regulatory Predictability: Shaping USP Standards - 12/11/2025

This discussion will show how USP public standards strengthen quality, streamline development, support regulatory compliance, and overall, increase regulatory predictability for drugs.

Published: Sep 29, 2025 | Category: FDA | Name: FDA Drugs

CDER Quantitative Medicine Center of Excellence (QM CoE)

The Center for Drug Evaluation and Research Quantitative Medicine Center of Excellence is established to facilitate and coordinate the continuous evolution and consistent application of quantitative medicine for drug development and regulatory decision-making across CDER.

Published: Sep 29, 2025 | Category: FDA | Name: FDA Drugs

Natco Pharma Limited - 672564 - 09/25/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Sep 29, 2025 | Category: FDA | Name: FDA Drugs

Natco Pharma Limited - 672564 - 04/08/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Sep 29, 2025 | Category: FDA | Name: FDA Drugs

FDA Clinical Investigator Training Course (CITC) 2024 - 12/10/2024

FDA Clinical Investigator Training Course (CITC) 2024

Published: Sep 29, 2025 | Category: FDA | Name: FDA Drugs

Some Homeopathic Products May Put You at Risk

Homeopathic products are marketed without FDA review and may not meet modern standards for safety, effectiveness, quality and labeling. Learn more.

Published: Sep 29, 2025 | Category: FDA | Name: FDA Drugs

E20 Adaptive Designs for Clinical Trials

Published: Sep 29, 2025 | Category: FDA | Name: FDA Drugs

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

MedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, special nutritional products, cosmetics and non-prescription human drug products marketed without an approved application.

Published: Sep 26, 2025 | Category: FDA | Name: FDA Drugs

Hiding in Plain Sight: 7-OH Products

7-OH: Emergence of a Fourth Opioid Epidemic

Published: Sep 26, 2025 | Category: FDA | Name: FDA Drugs

FDA approves new treatment for acromegaly, a rare endocrine disorder

The U.S. Food and Drug Administration (FDA) approved Palsonify (paltusotine) tablets to treat adults with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.

Published: Sep 26, 2025 | Category: FDA | Name: FDA Drugs

FDA Focuses on Closing the Clinical Trial Reporting Gap for Research Integrity

The FDA is committed to ensuring data transparency by promoting timely registration and reporting of results information to ClinicalTrials.gov.

Published: Sep 26, 2025 | Category: FDA | Name: FDA Drugs

MedWatch Forms for FDA Safety Reporting

Safety reporting portal for health professionals, patients, consumers and industry. Find pdf fillable forms in English and Spanish and a link to report safety concerns to the FDA online.

Published: Sep 26, 2025 | Category: FDA | Name: FDA Drugs

Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned - 09/23/2025

Opening Remarks by Sara Brenner, U.S. Food and Drug Administration September 23, 2025

Published: Sep 26, 2025 | Category: FDA | Name: FDA Drugs

ABECMA

ABECMA is the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Published: Sep 25, 2025 | Category: FDA | Name: FDA Biologics

FDA approves imlunestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

On September 25, 2025, the Food and Drug Administration approved imlunestrant (Inluriyo, Eli Lilly and Company), an estrogen receptor antagonist, for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.

Published: Sep 25, 2025 | Category: FDA | Name: FDA Drugs

FDA Authorizes Marketing of First Eyeglass Lenses to Slow Progression of Pediatric Myopia

Today, the U.S. Food and Drug Administration authorized marketing of the Essilor Stellest eyeglass lenses to correct myopia, commonly referred to as nearsightedness, with or without astigmatism and to slow the progression of the disease in children 6 to 12 years old at the initiation of treatment.

Published: Sep 25, 2025 | Category: FDA | Name: FDA Press Release

FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)

The U.S. Food and Drug Administration today announced that it has eliminated special safety requirements to monitor for serious heart rhythm problems in patients taking Caprelsa (vandetanib), an approved cancer medication made by Genzyme Corporation.

Published: Sep 25, 2025 | Category: FDA | Name: FDA Press Release

Tarmac Products, Inc. - 595993 - 09/18/2025

CGMP/QSR/Medical Devices/Adulterated

Published: Sep 25, 2025 | Category: FDA | Name: FDA Drugs

Tarmac Products, Inc. - 595993 - 11/09/2020

CGMP/QSR/Medical Devices/Adulterated

Published: Sep 25, 2025 | Category: FDA | Name: FDA Drugs

Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act

Information about Over-the-Counter (OTC) Monograph Reform

Published: Sep 25, 2025 | Category: FDA | Name: FDA Drugs

Key Information about Nonprescription, Over-the-Counter (OTC), Oral Phenylephrine

Information for consumers related to oral phenylephrine as an active ingredient in nonprescription drugs used to alleviate symptoms of cold, allergy and nasal congestion.

Published: Sep 25, 2025 | Category: FDA | Name: FDA Drugs

OTC Drug Review Process | OTC Drug Monographs

The Over-the-Counter (OTC) Drug Review was established to evaluate the safety and effectiveness of OTC drug products marketed in the United States before May 11, 1972.

Published: Sep 25, 2025 | Category: FDA | Name: FDA Drugs

From Our Perspective: OMUFA – Past, Current, and Future

The OTC Monograph drug user fee program, which we refer to as “OMUFA,” is similar to our other user fee programs, such as the Prescription Drug User Fee Act (PDUFA).

Published: Sep 25, 2025 | Category: FDA | Name: FDA Drugs

Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations

This is the draft guidance Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations

Published: Sep 24, 2025 | Category: FDA | Name: FDA Biologics

Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products

This is the draft guidance for industry Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products

Published: Sep 24, 2025 | Category: FDA | Name: FDA Biologics

Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

This is the draft guidance for industy Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

Published: Sep 24, 2025 | Category: FDA | Name: FDA Biologics

PDUFA VII Commitment: An Assessment of the Sentinel System (2022 to 2024)

Published: Sep 24, 2025 | Category: FDA | Name: FDA Drugs

FDA-TRACK: Biosimilar User Fee Act Procedural Response Goals Summary

Published: Sep 24, 2025 | Category: FDA | Name: FDA Drugs

Media Networks Sydney Pty. Limited - 711342 - 09/16/2025

Failure to Comply with Drug Listing Requirements/Misbranded

Published: Sep 24, 2025 | Category: FDA | Name: FDA Drugs

Flexi Bion may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Flexi Bion, a product promoted and sold for joint pain on various websites, including ebay.com, and possibly in some retail stores.

Published: Sep 23, 2025 | Category: FDA | Name: FDA Drugs

Piperacillin – Injection Products

Published: Sep 23, 2025 | Category: FDA | Name: FDA Drugs

Sleep, Skin, Bodybuilding and Other Product Notifications

Learn about the warnings for sleep, skin and bodybuilding products that contain hidden drugs and other hidden ingredients.

Published: Sep 23, 2025 | Category: FDA | Name: FDA Drugs

Agebox iKids Growth Night Formula may be harmful due to hidden ingredient

FDA laboratory analysis confirmed that Agebox iKids Growth Night Formula contains ibutamoren not listed on the product label.

Published: Sep 23, 2025 | Category: FDA | Name: FDA Drugs

Agebox iKids Growth Day Formula may be harmful due to hidden ingredient

FDA laboratory analysis confirmed that Agebox iKids Growth Day Formula contains ibutamoren not listed on the product label.

Published: Sep 23, 2025 | Category: FDA | Name: FDA Drugs

SILINTAN may be harmful due to hidden drug ingredient

FDA laboratory analysis confirmed that SILINTAN contains meloxicam not listed on the product label.

Published: Sep 23, 2025 | Category: FDA | Name: FDA Drugs

FDA-TRACK: Biosimilar User Fee Act Meeting Goals Summary

Published: Sep 23, 2025 | Category: FDA | Name: FDA Drugs

FDA-TRACK: Biosimilar User Fee Act Procedural Notification Goals Summary

Published: Sep 23, 2025 | Category: FDA | Name: FDA Drugs

General Principles of Software Validation

General validation principles of medical device software or the validation of software used to design, develop, or manufacture medical devices.

Published: Sep 23, 2025 | Category: FDA | Name: FDA Biologics

Ralph A. DeFronzo, M.D./University of Texas Health Science Center at San Antonio - 716773 - 09/17/2025

Clinical Investigator/Sponsor

Published: Sep 23, 2025 | Category: FDA | Name: FDA Drugs

motionpharmacy.com - 715595 - 09/10/2025

Unapproved New Drug/Misbranded

Published: Sep 23, 2025 | Category: FDA | Name: FDA Drugs

cheaptrustedpharmacy.com - 705501 - 07/29/2025

Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet

Published: Sep 23, 2025 | Category: FDA | Name: FDA Drugs

Janssen Vaccines Corp., A Johnson & Johnson Company - 713194 - 07/18/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Sep 23, 2025 | Category: FDA | Name: FDA Drugs

Cellebration LLC - 713252 - 09/12/2025

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Sep 23, 2025 | Category: FDA | Name: FDA Biologics

Stellalife, Inc. - 712804 - 09/16/2025

Unapproved New Drugs/Misbranded

Published: Sep 23, 2025 | Category: FDA | Name: FDA Drugs

PureRawz - 715218 - 09/08/2025

Unapproved New Drugs/Misbranded

Published: Sep 23, 2025 | Category: FDA | Name: FDA Drugs

Chengdu Brilliant Biopharmaceutical Co., Ltd. - 711330 - 09/11/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Sep 23, 2025 | Category: FDA | Name: FDA Drugs

FDA use of Real-World Evidence in Regulatory Decision Making

The studies presented in the accompanying tables exemplify instances in which the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) applied RWE in regulatory decision-making processes since 2011.

Published: Sep 22, 2025 | Category: FDA | Name: FDA Drugs

FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy

The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and

Published: Sep 22, 2025 | Category: FDA | Name: FDA Press Release

FDA Takes Action to Make a Treatment Available for Autism Symptoms

The U.S. Food and Drug Administration today initiated the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition that affects folate (a vitamin essential for brain health) transport into the brain.

Published: Sep 22, 2025 | Category: FDA | Name: FDA Press Release

Labeling and Promotion Guidances

This page lists Labeling and Promotion Guidance documents.

Published: Sep 22, 2025 | Category: FDA | Name: FDA Biologics

Malaria: Developing Drugs for Treatment

Published: Sep 22, 2025 | Category: FDA | Name: FDA Drugs

Publications from Office of Biostatistics Staff

Published: Sep 22, 2025 | Category: FDA | Name: FDA Drugs

FDA Grants Accelerated Approval to First Treatment for Barth Syndrome

The U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg.

Published: Sep 19, 2025 | Category: FDA | Name: FDA Press Release

The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development

Published: Sep 19, 2025 | Category: FDA | Name: FDA Drugs

Biosimilars Action Plan

FDA is committed to encouraging innovation and competition for biologics and facilitating the development of safe and effective biosimilars.

Published: Sep 19, 2025 | Category: FDA | Name: FDA Drugs

Aurora Pharmaceutical - 698797 - 02/07/2025

False & Misleading Claims/Misbranded

Published: Sep 19, 2025 | Category: FDA | Name: FDA Drugs

Elanco Animal Health - 695170 - 01/28/2025

False & Misleading Claims/Misbranded

Published: Sep 19, 2025 | Category: FDA | Name: FDA Drugs

FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection

On September 19, 2025, the Food and Drug Administration approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab.

Published: Sep 19, 2025 | Category: FDA | Name: FDA Drugs

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Announcement - 10/09/2025

On October 9, 2025, the Committee will meet in open session to discuss and make recommendations on the following separate topics. Topic I: the strain selection for the influenza virus vaccines for the 2026 Southern Hemisphere influenza season Topic II: advancing CBER’s allergen standardization program

Published: Sep 19, 2025 | Category: FDA | Name: FDA Biologics

Frequently Asked Questions about Drug Shortages

This page answers frequently asked questions (FAQ) about drug shortages such as what is a drug shortage, how many per year, how the FDA addresses and takes action on shortages, how the FDA notifies the public, what manufacturers are supposed to report to the FDA, and reasons for many drug shortages

Published: Sep 19, 2025 | Category: FDA | Name: FDA Drugs

Bulk Drug Substances Used in Compounding

Compounders sometimes produce drugs using bulk drug substances or active pharmaceutical ingredients. Because compounding from these substances presents risks to patients, sections 503A and 503B of the FD&C Act place limits on the bulk drug substances that can be used in compounding.

Published: Sep 19, 2025 | Category: FDA | Name: FDA Drugs

Primal Herbs Volume may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Primal Herbs Volume, a product promoted and sold for sexual enhancement on various websites, including primalherbs.com, and possibly in some retail stores.

Published: Sep 18, 2025 | Category: FDA | Name: FDA Drugs

Search List of Extended Use Dates to Assist with Drug Shortages

This is to update and consolidate the extended use date information posted previously to assist with drug shortage (6/15/17 to present).

Published: Sep 18, 2025 | Category: FDA | Name: FDA Drugs

FDA updates guidance on interchangeability

FDA issued a draft guidance for industry “Considerations for Demonstrating Interchangeability with a Reference Product: Update.” Learn more.

Published: Sep 18, 2025 | Category: FDA | Name: FDA Drugs

9 Things to Know About Biosimilars and Interchangeable Biosimilars

FDA experts share some interesting facts about to biosimilars and interchangeable biosimilars.

Published: Sep 18, 2025 | Category: FDA | Name: FDA Drugs

Spotlight on CDER Science

Published: Sep 18, 2025 | Category: FDA | Name: FDA Drugs

Advancing Clinical Trial Participation for the LGBTQIA+ Community

Representatives of the FDA were fortunate to attend a community discussion on advancing clinical trial diversity for sexual and gender minority communities to help improve the generalizability of trial results across the entire population of patients who may use medical products.

Published: Sep 18, 2025 | Category: FDA | Name: FDA Drugs

Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act

This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological products to make labeling changes based on new safety information that becomes available after approval of the drug.

Published: Sep 18, 2025 | Category: FDA | Name: FDA Drugs

Withdrawn and Expired Guidances | Drugs

Published: Sep 17, 2025 | Category: FDA | Name: FDA Drugs

FDA/Center for Research on Complex Generics (CRCG) Workshop on Modeling and Artificial Intelligence (AI) in Generic Drug Development and Product Lifecycle Management: Regulatory Insights and Future Trends - 10/15/2025

This 2-day hybrid (virtual and in-person) workshop focuses on exploring the opportunities, applications, and regulatory considerations of Artificial Intelligence (AI) in generic drug development and product lifecycle management.

Published: Sep 17, 2025 | Category: FDA | Name: FDA Drugs

Advancing Generic Drug Development: Translating Science to Approval - 09/21/2021

KEYNOTE SPEAKER - Janet Woodcock MD, Acting Commissioner of FDA

Published: Sep 17, 2025 | Category: FDA | Name: FDA Drugs

Understanding CDER’s Postmarket Safety Surveillance Programs and Public Data

CDER Conversation: Understanding CDER’s Postmarket Safety Surveillance Programs and Public Data

Published: Sep 17, 2025 | Category: FDA | Name: FDA Drugs

CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (CDER Quality Standards Program)

CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (CDER Quality Standards Program)Draft page

Published: Sep 17, 2025 | Category: FDA | Name: FDA Drugs

Drug Disposal: FDA’s Flush List for Certain Medicines

Check the flush list for select medicines you can immediately get rid of by flushing

Published: Sep 17, 2025 | Category: FDA | Name: FDA Drugs

Drug Disposal: Dispose "Non-Flush List" Medicine in Trash

Follow these simple steps before trashing medicines that are not on the flush list at home

Published: Sep 17, 2025 | Category: FDA | Name: FDA Drugs

Overview & Basics

Generic medicine facts, questions and answers, and FDA review and approval process.

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

What Is the Approval Process for Generic Drugs?

Overview of the FDA review and approval process for generic drugs

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Patient Education

Generic medications are just as safe and effective as their brand-name counterparts, and often cost less. To help educate patients about FDA’s rigorous review process, the economics of pricing, and related issues, FDA offers a range of educational materials, including videos, graphics, fact sheets,.

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Global Generic Drug Affairs

FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs.

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Office of Prescription Drug Promotion (OPDP) News

Review the latest news from the Office of Prescription Drug Promotion.

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Sunscreen: How to Help Protect Your Skin from the Sun

How you use sunscreens, and what other protective measures you take, make a difference in how well you are able to protect yourself and your family from sunburn, skin cancer, early skin aging and other risks of overexposure to the sun.

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Sunscreen Innovation Act | SIA

The Sunscreen Innovation Act (SIA) was enacted on November 26, 2014 to provide an alternative process for the review of safety and effectiveness of nonprescription sunscreen active ingredients.

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

OTC Monograph Reform: OTC Sunscreen Drugs - 12/15/2021

Webinar to discuss the deemed final order (DFO) for over-the-counter (OTC) sunscreen drugs and proposed order for OTC sunscreen drugs

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Compounding and the FDA: Questions and Answers

Creating a medication tailored to the needs of an individual patient. FDA answers the “what” and “why” of compounding. From consumers to health care professionals, there are many questions about compounding. FDA works to answer questions related to the meaning, intent and requirements of compounding

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Understanding the Risks of Compounded Drugs

Compounded drugs are not FDA-approved. This means the agency does not verify their safety, effectiveness or quality before they are marketed. Learn more.

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

CDER and CBER accept first submission to ISTAND Pilot Program

FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have accepted the agency’s first submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program.

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

FDA's ISTAND Pilot Program accepts a submission of first organ-on-a-chip technology designed to predict human drug-induced liver injury (DILI)

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: ANDEMBRY

ANDEMBRY is a medication used to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older.

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Investigational New Drug (IND) Application

Get to know the investigational new drug application (IND). This includes the types, laws and regulations, and emergency use of INDs.

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Novo Nordisk Inc. - 716495 - 09/09/2025

False & Misleading Claims/Misbranded

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

FWD Care, Inc. dba FWD - 716696 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Aytu Biopharma - 716599 - 09/09/2025

False & Misleading Claims/Misbranded

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Aytu Biopharma - 716604 - 09/09/2025

False & Misleading Claims/Misbranded

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Eli Lilly and Company - 716462 - 09/09/2025

False & Misleading Claims/Misbranded

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Eli Lilly and Company - 716475 - 09/09/2025

False & Misleading Claims/Misbranded

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Alora Pharmaceuticals - 716591 - 09/09/2025

False & Misleading Claims/Misbranded

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Get.Fit.Medical, LLC dba Get.Fit.Medical - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Somerset Therapeutics Private Limited - 711340 - 09/04/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Reset IV, LLC dba Reset IV - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

HealBerry - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

TRYM Health, Inc. dba TRYM Health - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Master Pharmaceuticals Group - 715800 - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Sprout Health Partners LLC dba Sprout Health - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

Biopreventative Company LLC dba Biopreventative - 09/09/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Published: Sep 16, 2025 | Category: FDA | Name: FDA Drugs

CSL Behring - 716297 - 09/09/2025

Advertising & Promotional Labeling/Drugs/Biological Products

Published: Sep 16, 2025 | Category: FDA | Name: FDA Biologics

NuVida Medical LLC - 707745 - 09/04/2025

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Sep 16, 2025 | Category: FDA | Name: FDA Biologics

VYJUVEK

For the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

Published: Sep 15, 2025 | Category: FDA | Name: FDA Biologics

FDA Online Controlled Substances Summit, Washington, D.C. - 09/11/2025

Opening Remarks by Grace Graham at the FDA Online Controlled Substances Summit, Washington, D.C. September 11, 2025 Speech by Grace Graham Deputy Commissioner for Policy, Legislation, and International Affairs - Food and Drug Administration FDA Online Controlled Substances Summit

Published: Sep 15, 2025 | Category: FDA | Name: FDA Drugs

FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products

The U.S. Food and Drug Administration today announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate the public’s ability to query real-time adverse event data on cosmetic products.

Published: Sep 12, 2025 | Category: FDA | Name: FDA Press Release

Influenza (Flu) Antiviral Drugs and Related Information

Published: Sep 12, 2025 | Category: FDA | Name: FDA Drugs

From Our Perspective

Insights from CDER leadership and experts on public health actions

Published: Sep 12, 2025 | Category: FDA | Name: FDA Drugs

Completed PDUFA VI Deliverables

Published: Sep 12, 2025 | Category: FDA | Name: FDA Drugs

How Modeling Was Used to Support the FDA Approval of a Topical Generic Drug Product

Impact Story

Published: Sep 12, 2025 | Category: FDA | Name: FDA Drugs

Office of Infectious Diseases Research Activities

Overview of research needs, requests for information (RFIs), public workshops/meetings, opportunities for collaboration (this applies to RFI), notable guidances related to regulatory science, externally awarded research studies, and other important regulatory science and research activities.

Published: Sep 12, 2025 | Category: FDA | Name: FDA Drugs

How physicians interpret information about prescription drugs in scientific publications vs. promotional pieces

Published: Sep 12, 2025 | Category: FDA | Name: FDA Drugs

Annual Licensure Reporting by Wholesale Drug Distributors and Third-Party Logistics Providers

Wholesale drug distributors and third-party logistics providers must be appropriately licensed and report licensure and other information to FDA annually to be authorized trading partners under the Drug Supply Chain Security Act. Learn more.

Published: Sep 12, 2025 | Category: FDA | Name: FDA Drugs

Quantitative Medicine Center of Excellence (QM CoE) Educational Resources

Discover educational resources available under the Quantitative Medicine Center of Excellence (QM CoE).

Published: Sep 11, 2025 | Category: FDA | Name: FDA Drugs

New developments in regulatory QSAR modeling: a new QSAR model for predicting blood brain barrier permeability

Published: Sep 11, 2025 | Category: FDA | Name: FDA Drugs

Untitled Letters Regarding Advertising & Promotional Labeling for Approved Biologics

Published: Sep 11, 2025 | Category: FDA | Name: FDA Biologics

Peptides, proteins, and the risks of cardiac arrythmias: A CDER study suggests that the human Thorough QT study is not needed for products comprised of naturally occurring amino acids

Peptides, proteins, and the risks of cardiac arrythmias: a CDER study suggests that the human Thorough QT study is not needed for products comprised of naturally occurring amino acids

Published: Sep 11, 2025 | Category: FDA | Name: FDA Drugs

CMC and GMP Guidances

This page lists CMC and GMP Guidance documents.

Published: Sep 11, 2025 | Category: FDA | Name: FDA Biologics

Impact Story: Capturing Patient Experience Through Deep Learning

CDER researchers are developing methods based on deep learning, a kind of artificial intelligence (AI), to capture patient experience of medical products in a way that allows essential information to be communicated, retrieved, and analyzed

Published: Sep 11, 2025 | Category: FDA | Name: FDA Drugs

Nonprescription Drugs Advisory Committee Charter

The Nonprescription Drugs Advisory Committee advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the FDA has regulatory responsibility.

Published: Sep 11, 2025 | Category: FDA | Name: FDA Drugs

Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications

Published: Sep 11, 2025 | Category: FDA | Name: FDA Drugs

Division of Applied Regulatory Science | Sampling of DARS Projects

Biomedical and Chemical Informatics; Adverse Event Profiling; Modeling to Inform Scheduling of Novel Substances of Abuse Potential; Chemical Structure-Activity Relationship Modeling; Tissue Based Biomarkers and Digital Quantification of Injury; Drug Transporters and Metabolism

Published: Sep 11, 2025 | Category: FDA | Name: FDA Drugs

CDER Statistical Studies Innovate Measures of Adhesion to Assess Generic Products

Drugs and the technologies used to deliver them evolve rapidly, and methods to evaluate them must be continually adapted to ensure the safety and efficacy of new medicines.

Published: Sep 11, 2025 | Category: FDA | Name: FDA Drugs

HHS, CBP Seize $86.5 Million Worth of Illegal E-Cigarettes in Largest-Ever Operation

The U.S. Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA), and U.S. Customs and Border Protection (CBP) today announced the seizure of 4.7 million units of unauthorized e-cigarette products with an estimated retail value of $86.5 million – the larges

Published: Sep 10, 2025 | Category: FDA | Name: FDA Press Release

XYNTHA

XYNTHA is a recombinant antihemophilic factor indicated in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, for perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes.

Published: Sep 10, 2025 | Category: FDA | Name: FDA Biologics

FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas

On September 10, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previous

Published: Sep 10, 2025 | Category: FDA | Name: FDA Drugs

Genetic Metabolic Diseases Advisory Committee Roster

Genetic Metabolic Diseases Advisory Committee Roster lists the current members and the current number of vacancies for the committee.

Published: Sep 10, 2025 | Category: FDA | Name: FDA Drugs

Spectrum Laboratory Products, Inc. Issues Voluntary Worldwide Recall of Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient (API) Due to Discoloration of Product

Spectrum Laboratory Products, Inc. is voluntarily recalling three lots of Epinephrine (L-Adrenaline) USP, a bulk active pharmaceutical ingredient (API) used to manufacture or compound prescription products, to the user level. Customer complaints have found the product to be discolored.

Published: Sep 10, 2025 | Category: FDA | Name: FDA Drugs

KVK-Tech, Inc. Issues Voluntary Nationwide Recall of One Lot of Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a Precautionary Measure Due to a Single Foreign Tablet Found During the Line Clearance After the Batch was Packaged

Newtown, Pennsylvania, KVK-Tech, Inc. is voluntarily recalling one lot (Batch Number: 17853A; “the batch”) of Betaxolol Tablets, USP 10 mg, White, Round, film coated biconvex tablets, debossed “K” above bisect “13” on one side and plain on the other side” to the consumer level. The batch was distrib

Published: Sep 10, 2025 | Category: FDA | Name: FDA Drugs

Development of Non-Opioid Analgesics for Chronic Pain

This draft guidance for industry is intended to assist sponsors in the development of non-opioid analgesics for the treatment of chronic pain.

Published: Sep 10, 2025 | Category: FDA | Name: FDA Drugs

FDA Issues New Guidance to Expand Non-Opioid Options for Chronic Pain, Curb Misuse

As part of its broader strategy to address the opioid crisis, the U.S. Food and Drug Administration today issued draft guidance titled “Development of Non-Opioid Analgesics for Chronic Pain” to accelerate safe and effective non-opioid treatments and to reduce prescription-related opioid misuse.

Published: Sep 10, 2025 | Category: FDA | Name: FDA Press Release

FDA Launches Crackdown on Deceptive Drug Advertising

The U.S. Department of Health and Human Services and the Food and Drug Administration today announced sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements.

Published: Sep 9, 2025 | Category: FDA | Name: FDA Press Release

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer

On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors

Published: Sep 9, 2025 | Category: FDA | Name: FDA Drugs

Office of Prescription Drug Promotion (OPDP) Research

The Office of Prescription Drug Promotion (OPDP) has an active research program designed to investigate applied and theoretical issues of relevance to direct-to-consumer (DTC) and professional promotional prescription drug materials.

Published: Sep 9, 2025 | Category: FDA | Name: FDA Drugs

OPDP eCTD

The OPDP eCTD page contains all resources and reference materials produced by OPDP in support of the OPDP Electronic Submissions Guidance.

Published: Sep 9, 2025 | Category: FDA | Name: FDA Drugs

Shirish M. Gadgeel, M.D. - 716181 - 09/04/2025

Clinical Investigator

Published: Sep 9, 2025 | Category: FDA | Name: FDA Drugs

Hikal Limited - 709370 - 08/20/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Sep 9, 2025 | Category: FDA | Name: FDA Drugs

Safety Labeling Change Orders

Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)) authorizes FDA to require application holders for certain drugs to make labeling changes based on new safety information. Learn more.

Published: Sep 8, 2025 | Category: FDA | Name: FDA Drugs

Biosimilars Guidances

This page lists Biosimilars Guidance documents.

Published: Sep 8, 2025 | Category: FDA | Name: FDA Drugs

E6(R3) Good Clinical Practice (GCP)

The Food and Drug Administration is announcing the availability of a final guidance for industry entitled “E6(R3) Good Clinical Practice.” This revision incorporates flexible, risk-based approaches and embraces innovations in trial design, conduct, and technology.

Published: Sep 8, 2025 | Category: FDA | Name: FDA Drugs

FDA’s Sixth Online Controlled Substances Summit - 09/11/2025

FDA, in partnership with the Reagan-Udall Foundation, will host the sixth Online Controlled Substances Summit on September 11, 2025.

Published: Sep 8, 2025 | Category: FDA | Name: FDA Drugs

Classification Categories for Certain Supplements Under BsUFA III

Published: Sep 8, 2025 | Category: FDA | Name: FDA Drugs

Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry

Published: Sep 8, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves Expanded Use of Vonvendi for von Willebrand Disease, Including for Certain Uses for Children

The U.S. Food and Drug Administration today approved expanded use of Vonvendi [von Willebrand factor (Recombinant)] for routine preventative (prophylactic) use in adults (age 18 years and older) with all types of von Willebrand disease (VWD) and on-demand and treatment of bleeding episodes and perio

Published: Sep 5, 2025 | Category: FDA | Name: FDA Press Release

FTX PLUS may be harmful due to hidden drug ingredients

FDA laboratory analysis confirmed that FTX PLUS contains dexamethasone phosphate and diclofenac not listed on the product label.

Published: Sep 5, 2025 | Category: FDA | Name: FDA Drugs

REUMA KING may be harmful due to hidden drug ingredients

FDA laboratory analysis confirmed that REUMA KING contains dexamethasone, diclofenac, and methocarbamol not listed on the product label.

Published: Sep 5, 2025 | Category: FDA | Name: FDA Drugs

FDA Launches Green List to Protect Americans from Illegal Imported GLP-1 Drug Ingredients

The U.S. Food and Drug Administration today established a “green list” import alert to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the U.S. market.

Published: Sep 5, 2025 | Category: FDA | Name: FDA Press Release

Drug Trials Snapshots: EKTERLY

Published: Sep 5, 2025 | Category: FDA | Name: FDA Drugs

TACHOSIL

Product approval information is indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.

Published: Sep 4, 2025 | Category: FDA | Name: FDA Biologics

Drug Trials Snapshots: IBTROZI

Published: Sep 4, 2025 | Category: FDA | Name: FDA Drugs

FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89

The U.S. Food and Drug Administration today announced that it will release future complete response letters (CRLs) promptly after they are issued to sponsors.

Published: Sep 4, 2025 | Category: FDA | Name: FDA Press Release

Complex Innovative Trial Design Meeting Program

As displayed in the Federal Register notice on August 1, 2018, FDA is conducting a Complex Innovative Designs (CID) Meeting Program to support the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs, as highlighted in the sixth iteration o

Published: Sep 4, 2025 | Category: FDA | Name: FDA Drugs

Search for Pharmaceutical Quality Documents

FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance documents, and compliance programs in a searchable and filterable table format

Published: Sep 3, 2025 | Category: FDA | Name: FDA Drugs

FDA Advances Rare Disease Drug Development with New Evidence Principles

FDA advanced Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability for the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect.

Published: Sep 3, 2025 | Category: FDA | Name: FDA Press Release

CDER/CBER Rare Disease Evidence Principles (RDEP)

CDER and CBER propose a new regulatory process for the approval of drugs to treat rare diseases with very small patient populations with significant unmet medical need.

Published: Sep 3, 2025 | Category: FDA | Name: FDA Drugs

FDA-TRACK: Prescription Drug User Fee Act Meeting Goals Summary

Published: Sep 3, 2025 | Category: FDA | Name: FDA Drugs

FDA-TRACK: Prescription Drug User Fee Act Procedural Goals Summary

Published: Sep 3, 2025 | Category: FDA | Name: FDA Drugs

FDA-TRACK: Prescription Drug User Fee Act Review Goals Summary

Published: Sep 3, 2025 | Category: FDA | Name: FDA Drugs

Drug Safety Oversight Board

The DSB is composed of representatives from two FDA Centers and eight other federal government agencies, the Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, Department of Defense.

Published: Sep 2, 2025 | Category: FDA | Name: FDA Drugs

FDA-TRACK: Prescription Drug User Fee Act Meeting Goals Summary

Published: Sep 2, 2025 | Category: FDA | Name: FDA Drugs

FDA-TRACK: Prescription Drug User Fee Act Procedural Goals Summary

Published: Sep 2, 2025 | Category: FDA | Name: FDA Drugs

FDA-TRACK: Prescription Drug User Fee Act Review Goals Summary

Published: Sep 2, 2025 | Category: FDA | Name: FDA Drugs

Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee) Roster

This page contains the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee) Roster, which lists the current members and the current number of vacancies for the committee.

Published: Sep 2, 2025 | Category: FDA | Name: FDA Drugs

Assessing Novel Efficacy Endpoints in Ophthalmologic Rare Disease Drug and Biologics Development - 09/17/2025

The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the U.S. Food and Drug Administration, is convening a one-day hybrid public meeting on September 17, 2025 focused on novel efficacy endpoints used in interventional clinical trials for drugs and biologics intended for patients with severe vision loss.

Published: Sep 2, 2025 | Category: FDA | Name: FDA Drugs

FDA Urges Nicotine Pouch Manufacturers To Use Child-Resistant Packaging Following Increasing Reports of Accidental Exposure

The U.S. Food and Drug Administration calls on nicotine pouch manufacturers to use child-resistant packaging to protect American children from accidental, harmful exposure.

Published: Sep 2, 2025 | Category: FDA | Name: FDA Press Release

FDA Approves Drug to Treat Adults with Persistent or Chronic Immune Thrombocytopenia

The U.S. Food and Drug Administration (FDA) approved Wayrilz (rilzabrutinib) tablets to treat adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to immunoglobulins, anti-D therapy, or corticosteroids.

Published: Sep 2, 2025 | Category: FDA | Name: FDA Drugs

Amneal Pharmaceuticals, LLC - 709894 - 08/27/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Sep 2, 2025 | Category: FDA | Name: FDA Drugs

Chromatography Institute of America dba Compounder’s International Analytical Laboratory - 708944 - 08/20/2025

CGMP/Finished Pharmaceutical/API/Adulterated

Published: Sep 2, 2025 | Category: FDA | Name: FDA Drugs

Wisconsin Pharmacal Company, LLC - 710329 - 08/22/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Sep 2, 2025 | Category: FDA | Name: FDA Drugs

Life Enthusiast Co-op - 709315 - 08/25/2025

Unapproved New Drugs/Ophthalmic Drug Products

Published: Sep 2, 2025 | Category: FDA | Name: FDA Drugs

Trew Balance - 709880 - 08/25/2025

Unapproved New Drugs/Ophthalmic Drug Products

Published: Sep 2, 2025 | Category: FDA | Name: FDA Drugs

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Signals of Serious Risks (FAERS)

Published: Aug 29, 2025 | Category: FDA | Name: FDA Drugs

April - June 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Signals of Serious Risks (FAERS)

Published: Aug 29, 2025 | Category: FDA | Name: FDA Drugs

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Signals of Serious Risks (FAERS)

Published: Aug 29, 2025 | Category: FDA | Name: FDA Drugs

Green Lumber Holding, LLC Issues Consumer Alert on Counterfeit Products Following FDA Findings

Costa Mesa, California August 28, 2025 - Green Lumber Holding, LLC (“Green Lumber”) is alerting consumers that counterfeit products misrepresented as genuine Green Lumber have been identified and may pose health risks.

Published: Aug 29, 2025 | Category: FDA | Name: FDA Drugs

DermaRite Industries Expands Voluntary Nationwide Recall Due to Potential Burkholderia cepacia Contamination

DermaRite Industries, LLC is expanding the voluntary recall initiated on July 16, due to potential microbial contamination identified as Burkholderia cepacia complex. Out of an abundance of caution the voluntary recall has expanded to include additional products and lots, which can be found in the t

Published: Aug 28, 2025 | Category: FDA | Name: FDA Drugs

Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee) Roster

This page contains the AMDAC roster, which lists the current members and the current number of vacancies for the committee

Published: Aug 28, 2025 | Category: FDA | Name: FDA Drugs

Roster of the Cellular, Tissue and Gene Therapies Advisory Committee

This is the Roster of the Cellular, Tissue and Gene Therapies Advisory Committee.

Published: Aug 28, 2025 | Category: FDA | Name: FDA Biologics

Roster of the Blood Products Advisory Committee

This is the Roster of the Blood Products Advisory Committee (BPAC).

Published: Aug 28, 2025 | Category: FDA | Name: FDA Biologics

FDA to recommend additional, earlier MRI monitoring for patients with Alzheimer’s disease taking Leqembi (lecanemab)

Published: Aug 28, 2025 | Category: FDA | Name: FDA Drugs

Vaccines and Related Biological Products Advisory Committee December 12, 2024 Meeting Announcement - 12/12/2024

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) December 12, 2024 meeting announcement and materials.

Published: Aug 28, 2025 | Category: FDA | Name: FDA Biologics

Vaccines and Related Biological Products Advisory Committee October 10, 2024 Meeting Announcement - 10/10/2024

This is the main page for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) October 10, 2024 Meeting announcement and meeting materials.

Published: Aug 28, 2025 | Category: FDA | Name: FDA Biologics

Vaccines and Related Biological Products Advisory Committee September 20, 2024 Meeting Announcement - 09/20/2024

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) September 20, 2024 Meeting announcement and meeting materials.

Published: Aug 28, 2025 | Category: FDA | Name: FDA Biologics

Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure

FDA’s surrogate endpoint table provides valuable information for drug developers on endpoints that may be considered and discussed with FDA for individual development programs.

Published: Aug 28, 2025 | Category: FDA | Name: FDA Drugs

Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Announcement - 06/05/2024

This is the main page for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) June 5, 2024 Meeting announcement and meeting materials.

Published: Aug 28, 2025 | Category: FDA | Name: FDA Biologics

Buying & Using Medicine Safely

The information in this section can help you work with your health professionals to make the best medicine choices, buy safely, and use medicine so it's as safe and effective as possible.

Published: Aug 28, 2025 | Category: FDA | Name: FDA Drugs

BeSafeRx: Your Source for Online Pharmacy Information

Explore FDA’s BeSafeRx campaign resources and tools so you can make safer, more informed decisions when purchasing prescription medicine from an online pharmacy.

Published: Aug 28, 2025 | Category: FDA | Name: FDA Drugs

Vaccines and Related Biological Products Advisory Committee March 5, 2024 Meeting Announcement - 03/05/2024

This is the main page for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) March 5, 2024 Meeting announcement and meeting materials.

Published: Aug 28, 2025 | Category: FDA | Name: FDA Biologics

BeSafeRx: Resources for Consumers

Online Pharmacy Risks and Safety Precautions: FDA provides additional information and resources for consumers who are thinking of buying prescription medicine online.

Published: Aug 28, 2025 | Category: FDA | Name: FDA Drugs

Natural Disaster Preparedness and Response | Drugs

Stay informed on FDA's guidance for drugs used in natural disaster preparedness and response. Learn about emergency drug supplies, FDA-approved treatments, and safety measures for public health during disasters like hurricanes, floods, and more.

Published: Aug 28, 2025 | Category: FDA | Name: FDA Drugs

Using Fat-Dissolving Injections That Are Not FDA Approved Can Be Harmful

Published: Aug 28, 2025 | Category: FDA | Name: FDA Drugs

Withdrawn Guidances (Biologics)

This page displays withdrawn CBER guidance documents

Published: Aug 27, 2025 | Category: FDA | Name: FDA Biologics

Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to Mislabeling

08/27/2025– East Brunswick, NJ, Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level. The Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing Meloxicam

Published: Aug 27, 2025 | Category: FDA | Name: FDA Drugs

Novavax COVID-19 Vaccine, Adjuvanted

Published: Aug 27, 2025 | Category: FDA | Name: FDA Biologics

FDA removes risk evaluation and mitigation strategy (REMS) program for the antipsychotic drug Clozapine

Published: Aug 27, 2025 | Category: FDA | Name: FDA Drugs

Cellular, Tissue, and Gene Therapies Advisory Committee October 31, 2023 Meeting Announcement - 10/31/2023

This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) October 31, 2023 meeting announcement and materials main page.

Published: Aug 27, 2025 | Category: FDA | Name: FDA Biologics

Vaccines and Related Biological Products Advisory Committee October 5, 2023 Meeting Announcement - 10/05/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) October 5, 2023 announcement and meeting materials.

Published: Aug 27, 2025 | Category: FDA | Name: FDA Biologics

Regulatory Pharmaceutical Fellowship Program

Explore the FDA’s Regulatory Pharmaceutical Fellowship Program, a partnership with academia and industry, offering specialized training in regulatory science, policy, and drug development. Learn how to advance your career in the pharmaceutical field through this unique fellowship opportunity.

Published: Aug 27, 2025 | Category: FDA | Name: FDA Drugs

FDA accepts proposal for reasonably likely surrogate endpoint for ‘MASH’ all-cause mortality or liver-related events

Published: Aug 27, 2025 | Category: FDA | Name: FDA Drugs

Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Announcement - 05/18/2023

This is the main landing page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) May 18, 2023 Meeting announcement and meeting materials.

Published: Aug 27, 2025 | Category: FDA | Name: FDA Biologics

Cellular, Tissue, and Gene Therapies Advisory Committee May 12, 2023 Meeting Announcement - 05/12/2023

This is the main landing page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) May 12, 2023 Meeting Announcement and meeting materials.

Published: Aug 27, 2025 | Category: FDA | Name: FDA Biologics

Blood Products Advisory Committee April 26, 2023 Meeting Announcement - 04/26/2023

This is the main page for the Blood Products Advisory Committee April 26, 2023 Meeting Announcement and meeting materials.

Published: Aug 27, 2025 | Category: FDA | Name: FDA Biologics

Vaccines and Related Biological Products Advisory Committee March 7, 2023 Meeting Announcement - 03/07/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee March 7, 2023 Meeting Announcement and meeting materials.

Published: Aug 27, 2025 | Category: FDA | Name: FDA Biologics

Vaccines and Related Biological Products Advisory Committee February 28-March 1, 2023 Meeting Announcement - 02/28/2023

This is the main landing page for the Vaccines and Related Biological Products Advisory Committee February 28 - March 1, 2023 Meeting Announcement and meeting materials.

Published: Aug 27, 2025 | Category: FDA | Name: FDA Biologics

Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention

Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse

Published: Aug 27, 2025 | Category: FDA | Name: FDA Drugs

PAIN FLEX may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use PAIN FLEX, a product promoted and sold for joint pain on various websites, including Amazon.com and possibly in some retail stores.

Published: Aug 26, 2025 | Category: FDA | Name: FDA Drugs

Overview of our role regulating and approving drugs | Video series

Learn how the FDA regulates drugs using science and data to ensure their safety, quality and efficacy. FDA plays a vital role in drug development and approval process. Watch our informative video series on FDA drugs, FDA approval, and the drug development process.

Published: Aug 26, 2025 | Category: FDA | Name: FDA Drugs

Approved Drugs: Questions and Answers

How is a medicine approved by FDA?, How can I find out if my medicine is approved by FDA?

Published: Aug 26, 2025 | Category: FDA | Name: FDA Drugs

Citalopram (marketed as Celexa) Information

Published: Aug 26, 2025 | Category: FDA | Name: FDA Drugs

AlzClipp / UniUni - 711274 - 07/29/2025

Unapproved New Drugs/Misbranded

Published: Aug 26, 2025 | Category: FDA | Name: FDA Drugs

Innate Healthcare Institute - 695592 - 08/15/2025

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Aug 26, 2025 | Category: FDA | Name: FDA Biologics

Platinum Biologics LLC - 705090 - 08/15/2025

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Aug 26, 2025 | Category: FDA | Name: FDA Biologics

OPDP’s Social Science Research Program: Aiming to Understand How Health Care Providers and Patients Interpret Prescription Drug Information

CDER’s Office of Prescription Drug Promotion (OPDP)’s four-person research team investigates issues in direct-to-consumer and health care provider-directed prescription drug promotional communications. The team uses methodologies such as surveys, experimental research, and qualitative research

Published: Aug 25, 2025 | Category: FDA | Name: FDA Drugs

Information for Health Care Professionals | Drugs

Drug Information for Health Care Professionals, including drug labeling and safety information.

Published: Aug 25, 2025 | Category: FDA | Name: FDA Drugs

Development & Approval Process | Drugs

Get to know FDA’s drug development and approval process -- ensuring that drugs work and that the benefits outweigh their known risks.

Published: Aug 25, 2025 | Category: FDA | Name: FDA Drugs

FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria

Published: Aug 25, 2025 | Category: FDA | Name: FDA Drugs

Guidance Documents for Drug Applications

Guidance documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products.

Published: Aug 25, 2025 | Category: FDA | Name: FDA Drugs

Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment Public Meeting - 09/24/2025

The Food and Drug Administration (FDA) is holding a hybrid public meeting titled "Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment on 9/24/2025.

Published: Aug 25, 2025 | Category: FDA | Name: FDA Drugs

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication

On August 22, 2025,the US FDA’s Center for Biologics Evaluation and Research has suspended the biologics license for Valneva Austria GmbH’s Ixchiq (Chikungunya Vaccine, Live). This vaccine was initially approved by FDA under the accelerated approval pathway in November of 2023 for the prevention of

Published: Aug 25, 2025 | Category: FDA | Name: FDA Biologics

First Generic Drug Approvals

Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for pati

Published: Aug 22, 2025 | Category: FDA | Name: FDA Drugs

Division of Oncology 2 (DO2)

The Division of Oncology 2 (DO2) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) for the following therapeutic areas: gastrointestinal, lung, and head and neck cancers; neuro-oncology, rare cancers, pediatric

Published: Aug 22, 2025 | Category: FDA | Name: FDA Drugs

FDA Office of Hematology Oncology Products Reorganizes, Renamed Office of Oncologic Diseases

Office Renaming

Published: Aug 22, 2025 | Category: FDA | Name: FDA Drugs

FDA Begins Real-Time Reporting of Adverse Event Data

The U.S. Food and Drug Administration (FDA) today began publishing adverse event data on a daily basis, giving the public faster access to information on serious medication errors and product quality complaints for prescription drugs and therapeutic biologics.

Published: Aug 22, 2025 | Category: FDA | Name: FDA Press Release

Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments - 09/30/2025

On September 30, 2025 FDA will hold its annual public meeting and opportunity for public comment on Financial Transparency and Efficiency of PDUFA, BsUFA, and GDUFA.

Published: Aug 22, 2025 | Category: FDA | Name: FDA Drugs

Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments | 2021 - 06/28/2021

This public meeting is intended to meet performance commitments included in PDUFA VI, BsUFA II, and GDUFA II.

Published: Aug 22, 2025 | Category: FDA | Name: FDA Drugs

CDER Guidance Agenda

Published: Aug 22, 2025 | Category: FDA | Name: FDA Drugs

Primary Care Providers Can Prescribe with Confidence

Information and resources are available to help primary care providers manage OUD with the help of medications for opioid use disorder (MOUD).

Published: Aug 21, 2025 | Category: FDA | Name: FDA Drugs

FDA Rationale for Recognition Decision: Voriconazole

Published: Aug 21, 2025 | Category: FDA | Name: FDA Drugs

FDA Rationale for Piperacillin-Tazobactam Breakpoints for Enterobacterales

Published: Aug 21, 2025 | Category: FDA | Name: FDA Drugs

FDA Rationale for Piperacillin Tazobactam Breakpoints for Pseudomonas aeruginosa

Published: Aug 21, 2025 | Category: FDA | Name: FDA Drugs

FDA Rationale for Recognition Decision: Daptomycin

Published: Aug 21, 2025 | Category: FDA | Name: FDA Drugs

Rationale for FDA's Position on Ceftazidime Breakpoints against Stenotrophomonas Maltophilia

Published: Aug 21, 2025 | Category: FDA | Name: FDA Drugs

FDA Rationale for Recognition Decision: Ceftaroline fosamil

Published: Aug 21, 2025 | Category: FDA | Name: FDA Drugs

FDA Rationale for Recognition Decision: Cefiderocol

Published: Aug 21, 2025 | Category: FDA | Name: FDA Drugs

Rationale for FDA’s Position on the Cefazolin Breakpoints for Enterobacterales

Published: Aug 21, 2025 | Category: FDA | Name: FDA Drugs

Rationale for FDA’s Position on the Use of Cefazolin Breakpoints as a Surrogate for Determining Breakpoints for Oral Cephalosporins for the Treatment of Uncomplicated Urinary Tract Infections

Published: Aug 21, 2025 | Category: FDA | Name: FDA Drugs

FDA Rationale for Breakpoints Recognition Decision: Azithromycin and Neisseria gonorrhoeae

Published: Aug 21, 2025 | Category: FDA | Name: FDA Drugs

Rezafungin Injection

Rezafungin Injection Recognized Interpretive Criteria

Published: Aug 21, 2025 | Category: FDA | Name: FDA Drugs

Setting and Implementing Standards for Narrow Therapeutic Index Drugs

CDER's Narrow Therapeutic Index Drugs (NTI) working group works to resolve key NTI scientific and regulatory issues.

Published: Aug 20, 2025 | Category: FDA | Name: FDA Drugs

Advancing Generic Drug Development: Translating Science to Approval 2025 - 10/07/2025

Join us for the 2025 Advancing Generic Drug Development Workshop! FDA experts will demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval.

Published: Aug 20, 2025 | Category: FDA | Name: FDA Drugs

B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL Due to the Presence of Particulate Matter

For Immediate Release - BETHLEHEM, PA – August 19, 2025 – B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000 mL,and 0.9% Sodium Chloride Injection USP 1000 mL to the hospital level due to the presence of particulate matter inside the container.

Published: Aug 19, 2025 | Category: FDA | Name: FDA Drugs

FDA Rationale for Recognition Decision: Isavuconazonium sulfate

Published: Aug 19, 2025 | Category: FDA | Name: FDA Drugs

www.usaquickmeds.com - 713312 - 08/01/2025

Misbranded and Unapproved New Drugs

Published: Aug 19, 2025 | Category: FDA | Name: FDA Drugs

Anhui Hanbon Daily Chemical Co., Ltd. - 708903 - 08/11/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Aug 19, 2025 | Category: FDA | Name: FDA Drugs

Everlaan Organics, Inc. dba Maple Organics - 707956 - 08/11/2025

CGMP/OTC/Unapproved New Drugs/Misbranded

Published: Aug 19, 2025 | Category: FDA | Name: FDA Drugs

Boothwyn Pharmacy LLC - 710247 - 06/09/2025

Unapproved New Animal Drug/Adulterated/Misbranded

Published: Aug 19, 2025 | Category: FDA | Name: FDA Drugs

HHS Allows FDA Emergency Use of Animal Drugs to Combat New World Screwworm, Protect U.S. Food Supply

The U.S. Department of Health and Human Services (HHS) today issued a declaration that allows the U.S. Food and Drug Administration (FDA) to issue Emergency Use Authorizations (EUAs) for animal drugs to treat or prevent infestations caused by the New World Screwworm (NWS).

Published: Aug 19, 2025 | Category: FDA | Name: FDA Press Release

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions

Published: Aug 18, 2025 | Category: FDA | Name: FDA Drugs

Patient-Focused Drug Development: Workshop #2 to Discuss Methodologic and Other Challenges Related to Patient Experience Data - 09/18/2025

On September 18 and 19, 2025, the U.S. Food and Drug Administration (FDA) is hosting a virtual public workshop to discuss methodological challenges related to patient experience data encountered, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, as well as other ar

Published: Aug 18, 2025 | Category: FDA | Name: FDA Drugs

Approaches to Assessment of Overall Survival in Oncology Clinical Trials

Published: Aug 18, 2025 | Category: FDA | Name: FDA Drugs

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development

Published: Aug 18, 2025 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: ENFLONSIA

Published: Aug 18, 2025 | Category: FDA | Name: FDA Drugs

Public Notification: Green Lumber contains hidden drug ingredient

[9-19-2019] The Food and Drug Administration is advising consumers not to purchase or use Green Lumber, a product promoted and sold for male sexual enhancement on various websites, including www.getgreenlumber.com (redirects to www.greenlumber.com), and possibly in some retail stores.

Published: Aug 15, 2025 | Category: FDA | Name: FDA Drugs

BK251199 - NLF system® kit 2 (EUROMI)

The NLF SYSTEM® kit is indicated for removing tissues and/or liquids from the body following an infiltration of tumescent solutions, during surgical procedures, including liposuction, and injecting autologous adipose tissues, “lipofilling,” for aesthetic body contouring purposes.

Published: Aug 15, 2025 | Category: FDA | Name: FDA Biologics

Drug Trials Snapshots: EMRELIS

Published: Aug 15, 2025 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshot: TRYPTYR

TRYPTYR is a TRPM8 thermoreceptor agonist that treats the signs and symptoms of dry eye disease (DED) in adults with history of DED.

Published: Aug 15, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis

FDA approved Papzimeos, the first-of-its-kind non-replicating adenoviral vector-based immunotherapy for use in adults with recurrent respiratory papillomatosis.

Published: Aug 14, 2025 | Category: FDA | Name: FDA Press Release

Acetaminophen

This is a consumer webpage focused on the safe use of over-the-counter acetaminophen-containing products.

Published: Aug 14, 2025 | Category: FDA | Name: FDA Drugs

The Center for Research on Complex Generics

FDA awards a 5-year grant to the University of Maryland and the University of Michigan to establish a Center for Research on Complex Generics (CRCG).

Published: Aug 14, 2025 | Category: FDA | Name: FDA Drugs

Lessons Learned From the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program - 09/10/2025

The meeting will feature perspectives from both industry leaders and FDA regulators, who will discuss best practices and lessons learned from the pilot program.

Published: Aug 14, 2025 | Category: FDA | Name: FDA Drugs

FDA takes steps to decrease barriers for overdose reversal agents with Dr. Marta Sokolowska

FDA takes steps to decrease barriers for overdose reversal agents with Dr. Marta Sokolowska

Published: Aug 14, 2025 | Category: FDA | Name: FDA Drugs

Drug Shortages with CDR Emily Thakur

In this podcast series, we answer some of the most frequently asked questions we’ve received from the public.

Published: Aug 14, 2025 | Category: FDA | Name: FDA Drugs

FDA’s Overdose Prevention Framework with Dr. Marta Sokolowska

Published: Aug 14, 2025 | Category: FDA | Name: FDA Drugs

Clinical Trial Basics

Shedding some light on clinical trials with Dr. Bob Temple

Published: Aug 14, 2025 | Category: FDA | Name: FDA Drugs

Conversation on Paxlovid

In today’s episode, we’ll be discussing Paxlovid, which is now widely available in community pharmacies.

Published: Aug 14, 2025 | Category: FDA | Name: FDA Drugs

Switching Between Biosimilars and Their Reference Counterparts with Dr. Sarah Yim

Listen to our latest podcast series, Q&A with FDA, on Switching Between Biosimilars and Their Reference Counterparts, featuring Dr. Sarah Yim.

Published: Aug 14, 2025 | Category: FDA | Name: FDA Drugs

Understanding FDA Terms for Possible New Therapies to Prevent and Treat Diseases

The FDA is responsible for protecting public health by ensuring the safety and effectiveness of drugs, biologics and medical devices. Sometimes, the FDA allows the emergency use of medical products not yet approved. Here’s what some of those terms used to describe potential treatments mean.

Published: Aug 14, 2025 | Category: FDA | Name: FDA Drugs

Pediatric Anesthesia

Published: Aug 14, 2025 | Category: FDA | Name: FDA Drugs

Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid Products

Published: Aug 13, 2025 | Category: FDA | Name: FDA Press Release

Safe Use Initiative - Current Projects

Part of Safe Use Initiative (updated)

Published: Aug 13, 2025 | Category: FDA | Name: FDA Drugs

Workshops, Meetings & Conferences (Biologics)

Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

Published: Aug 13, 2025 | Category: FDA | Name: FDA Biologics

Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program

Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program (CDRP)

Published: Aug 13, 2025 | Category: FDA | Name: FDA Drugs

Pediatric Developmental Safety Assessment: New Approach Methods - 12/05/2025

A one-day workshop focusing on using new approach methods to assess pediatric developmental safety during drug development.

Published: Aug 13, 2025 | Category: FDA | Name: FDA Drugs

Blood Grouping and Phenotyping Reagents

Blood Grouping and Phenotyping Reagents Main Page listed in alphabetical order by manufacturer, then by product

Published: Aug 13, 2025 | Category: FDA | Name: FDA Biologics

ICH M13B Webinar: Navigating the Draft ICH M13B Additional Strengths Biowaiver Guideline - 09/11/2025

This webinar will provide an in-depth look at the draft ICH M13B guideline titled "Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver" that was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly in March 2025.

Published: Aug 12, 2025 | Category: FDA | Name: FDA Drugs

FDA/Center for Research on Complex Generics (CRCG) Workshop on Mastering Particle Size Analysis: A Step-By-Step Illustration of Techniques and Best Practices - 09/23/2025

This workshop is intended to help accelerate the development and approval of complex generic drug products, improving drug affordability, increasing American patient access to these medicines, and mitigating the risk of drug shortages for these complex generic products.

Published: Aug 12, 2025 | Category: FDA | Name: FDA Drugs

GFA Production (Xiamen) Co., Ltd. Issues Voluntary Nationwide Recall of Easy Care First Aid® Burn Cream and First Aid Kits Due to Microbial Contamination

Xiamen, Fujian, GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care first aid® AfterBurn® Cream, 0.9 g single-use packets. The single use packets are sold in boxes of 10 or packaged in certain First Aid kits. This recall is to the consumer level. FDA analysis found the p

Published: Aug 12, 2025 | Category: FDA | Name: FDA Drugs

Amneal Pharmaceuticals, LLC. Issues a Nationwide Voluntary Recall of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL, Due to the Potential for Some Bottles to be Super Potent Which May be Harmful

Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can res

Published: Aug 12, 2025 | Category: FDA | Name: FDA Drugs

Gussyup LLC dba Private Label Grooming - 709488 - 07/09/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Aug 12, 2025 | Category: FDA | Name: FDA Drugs

Supergoop! - 711018 - 08/06/2025

OTC/Unapproved New Drug/Misbranded

Published: Aug 12, 2025 | Category: FDA | Name: FDA Drugs

Fallien Cosmeceuticals Ltd. dba Fallene Ltd. - 711006 - 08/06/2025

OTC/Unapproved New Drug/Misbranded

Published: Aug 12, 2025 | Category: FDA | Name: FDA Drugs

K & Care Organics - 711000 - 08/06/2025

OTC/Unapproved New Drug/Misbranded

Published: Aug 12, 2025 | Category: FDA | Name: FDA Drugs

Kalani AB dba Kalani Sunwear - 710998 - 08/06/2025

OTC/Unapproved New Drug/Misbranded

Published: Aug 12, 2025 | Category: FDA | Name: FDA Drugs

Vacation Inc. - 706039 - 08/06/2025

OTC/Unapproved New Drug/Misbranded

Published: Aug 12, 2025 | Category: FDA | Name: FDA Drugs

Confer With - 707691 - 08/01/2025

Unapproved New Drugs/Misbranded

Published: Aug 12, 2025 | Category: FDA | Name: FDA Drugs

Eco-NAMs Webinar Series | State of the Science for Bioaccumulation: An Integrated, Weight of Evidence Approach - 09/10/2025

The webinar will feature presentations by Dr. Pippa Curtis-Jackson, Senior Specialist at the Chemical Assessment Unit, UK EA, and Dr. Michelle Embry, Deputy Director of HESI.

Published: Aug 12, 2025 | Category: FDA | Name: FDA Drugs

PDUFA Performance Reports

Published: Aug 11, 2025 | Category: FDA | Name: FDA Drugs

DermaRite Industries Issues Voluntary Nationwide Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products Due to Burkholderia cepacia Contamination

DermaRite Industries, LLC is voluntarily recalling individual lots of products in the table below due to microbial contamination identified as Burkholderia cepecia.

Published: Aug 9, 2025 | Category: FDA | Name: FDA Drugs

FDA Commissioner Makary, USDA Secretary Rollins Celebrate Proposed Modernization of Orange Juice Regulations to Benefit American Growers

U.S. FDA Commissioner Dr. Marty Makary, M.D., M.P.H., and U.S. Secretary of Agriculture Brooke L. Rollins this week announced plans to support American citrus growers and cut bureaucratic barriers by proposing an update to the standard of identity (SOI) for pasteurized orange juice.

Published: Aug 8, 2025 | Category: FDA | Name: FDA Press Release

Compounding when Drugs are on FDA’s Drug Shortages List

FDA understands that when a drug is in shortage, patients and health care professionals may look to compounded drugs as an option to get the medication they need.

Published: Aug 8, 2025 | Category: FDA | Name: FDA Drugs

Human Drug Compounding Policies and Rules

List of compounding policy documents and related materials

Published: Aug 8, 2025 | Category: FDA | Name: FDA Drugs

Compounding Quality Center of Excellence

Compounded drugs pose unique risks to patients because they are not reviewed by the agency for safety, effectiveness or quality. The Center of Excellence FDA will explore new ways to engage and collaborate with outsourcing facilities to improve the overall quality of compounded drugs.

Published: Aug 8, 2025 | Category: FDA | Name: FDA Drugs

FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations

On August 8, 2025, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyros

Published: Aug 8, 2025 | Category: FDA | Name: FDA Drugs

A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: Announcing Resolution of the IV Saline Solutions Shortage

Published: Aug 8, 2025 | Category: FDA | Name: FDA Press Release

Health Fraud Scams

Learn how to spot health fraud and avoid it.

Published: Aug 8, 2025 | Category: FDA | Name: FDA Drugs

Report on the State of Pharmaceutical Quality

The mission of the Office of Pharmaceutical Quality is to assure that quality medicines are available to the American public. The annual Report on the State of Pharmaceutical Quality is intended to help characterize the quality of the U.S. drug supply chain. Learn more.

Published: Aug 8, 2025 | Category: FDA | Name: FDA Drugs

Ananeoo Wellness LLC - Online Advisory Letter

Advisory letter issued to Ananeoo Wellness LLC for the marketing of Ananeoo Cellular Nutrition & Detoxification on ananeoowellness.com

Published: Aug 8, 2025 | Category: FDA | Name: FDA Drugs

Emergency Investigational New Drug (EIND) Applications for Antiviral Products

Published: Aug 8, 2025 | Category: FDA | Name: FDA Drugs

Generic Drug Research Publications & Resources

The results of research studies conducted GDUFA initiatives provide new tools for FDA to evaluate generic drug equivalence.

Published: Aug 7, 2025 | Category: FDA | Name: FDA Drugs

Generic Drug Research Collaboration Opportunities

The Office of Generic Drugs implements the GDUFA Regulatory Science Research Program by collaborating through grants or contracts.

Published: Aug 7, 2025 | Category: FDA | Name: FDA Drugs

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live): FDA Safety Communication

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Removes Recommended Pause in Use and Approves Required Updated Labeling: FDA Safety Communication

Published: Aug 7, 2025 | Category: FDA | Name: FDA Biologics

FDA Actions to Remove Unapproved Drugs from the Market by Drug

This page lists FDA Actions to Remove Unapproved Drugs from the Market by Drug

Published: Aug 7, 2025 | Category: FDA | Name: FDA Drugs

FDA’s Actions to Address Unapproved Thyroid Medications

Published: Aug 7, 2025 | Category: FDA | Name: FDA Drugs

President's Emergency Plan for AIDS Relief (PEPFAR)

Presidential Emergency Plan for AIDS Relief content

Published: Aug 7, 2025 | Category: FDA | Name: FDA Drugs

FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing

The U.S. Food and Drug Administration today announced FDA PreCheck, a new program to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing sites in the United States.

Published: Aug 7, 2025 | Category: FDA | Name: FDA Press Release

Safely Using Hand Sanitizer

You can help stop the spread of infectious diseases by washing your hands with soap and water for 20 seconds every time. If soap and water are not available, alcohol-based hand sanitizers can be used if they contain at least 60% alcohol and are used properly.

Published: Aug 6, 2025 | Category: FDA | Name: FDA Drugs

Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers

FDA has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U.S.

Published: Aug 6, 2025 | Category: FDA | Name: FDA Drugs

Coronavirus (COVID-19) Update: Daily Roundup April 13, 2020

Coronavirus (COVID-19) Update: Daily Roundup

Published: Aug 6, 2025 | Category: FDA | Name: FDA Drugs

FDA grants accelerated approval to dordaviprone for diffuse midline glioma

On August 6, 2025, the Food and Drug Administration granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals, Inc.), a protease activator, for adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation.

Published: Aug 6, 2025 | Category: FDA | Name: FDA Drugs

Fiscal Year 2024 Generic Drug Science and Research Initiatives Public Workshop - 05/20/2024

The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives.

Published: Aug 6, 2025 | Category: FDA | Name: FDA Drugs

The Future of Registries in Oncology - 08/27/2025

The public meeting will be held on Wednesday August 27, 2025 and Thursday August 28, 2025, from 10 a.m. to 1 p.m. The meeting agenda, biographies, additional materials, and any other updates will also be posted to this website as they become available.

Published: Aug 5, 2025 | Category: FDA | Name: FDA Drugs

Oasis Medical, Inc. - 707198 - 07/15/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Aug 5, 2025 | Category: FDA | Name: FDA Drugs

How to Request Domperidone for Expanded Access Use

FDA recognizes that there are some patients with severe gastrointestinal motility disorders that are difficult to manage with available therapy for whom domperidone’s potential benefits may justify its potential risks. Patients 12 years of age and older with certain gastrointestinal (GI) conditions

Published: Aug 4, 2025 | Category: FDA | Name: FDA Drugs

FDA Names Top HHS Lawyer as Chief Counsel

The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced that Sean Keveney has been appointed Chief Counsel at the FDA.

Published: Aug 4, 2025 | Category: FDA | Name: FDA Press Release

Impact Stories

Stories illustrating how regulatory science impacts the lives and health of people

Published: Aug 4, 2025 | Category: FDA | Name: FDA Drugs

Native Remedies dba Silver Star Brands - 612268 - 02/18/2021

New Drug/Misbranded

Published: Aug 4, 2025 | Category: FDA | Name: FDA Drugs

Streamlining analysis of ion channel in vitro assays data to support clinical cardiac safety decision-making

CDER researchers are developing an approach that enables sharing and analyzing large volumes of cardiac electrophysiology in vitro data and streamlines the analysis and interpretation of these nonclinical data to support clinical cardiac safety decision making.

Published: Aug 4, 2025 | Category: FDA | Name: FDA Drugs

FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use: Drug Safety Communication

FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use. Class-Wide Action Will Further Emphasize and Characterize Risks of Long-Term Use to Help Patients, Health Care Professionals Make Informed Treatment Decisions: Drug Safety Communication

Published: Aug 4, 2025 | Category: FDA | Name: FDA Drugs

Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (Containing Benzyl Alcohol), Due To The Potential Presence of Visible Particulates

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial; lot EA7470, to the user level due to visible particulates observed in two vials during annual examination of retention samples.

Published: Aug 1, 2025 | Category: FDA | Name: FDA Drugs

Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination

Lawrence, Kansas – Plastikon Healthcare, LLC is voluntarily recalling one (1) lot of Milk of Magnesia 2400 mg/10 mL Oral Suspension, one (1) lot of Milk of Magnesia 2400 mg/30 mL Oral Suspension, eleven (11) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL

Published: Aug 1, 2025 | Category: FDA | Name: FDA Drugs

FDASIA Section 705 Annual Reports

Annual Reports published by requirement of FDASIA Section 705

Published: Aug 1, 2025 | Category: FDA | Name: FDA Drugs

FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks

Published: Jul 31, 2025 | Category: FDA | Name: FDA Press Release

FDA is requiring opioid pain medicine manufacturers to update prescribing information regarding long-term use

FDA is requiring safety labeling changes for opioid pain medicines to further emphasize and characterize the risks associated with long-term use.

Published: Jul 31, 2025 | Category: FDA | Name: FDA Drugs

Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs

Published: Jul 31, 2025 | Category: FDA | Name: FDA Drugs

Innovative Science and Technology Approaches for New Drugs (ISTAND) Program Submission Process

The 21st Century Cures Act formally established a multi-step process for Drug Development Tools (DDT) qualification. Qualification of a DDT is for a specific context of use (COU), and the qualified DDT may be used for the COU by any person in drug or biologics development.

Published: Jul 31, 2025 | Category: FDA | Name: FDA Drugs

CDER Conversation: Novel Excipient Review Pilot Program

FDA’s Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND) recently launched a pilot program on Novel Excipient Review. The pilot program offers a new pathway for drug manufacturers to obtain FDA review of certain novel excipients (inactive ingredients)

Published: Jul 31, 2025 | Category: FDA | Name: FDA Drugs

Digital Health Technologies (DHTs) for Drug Development

Published: Jul 31, 2025 | Category: FDA | Name: FDA Drugs

Innovative Science and Technology Approaches for New Drugs (ISTAND) Program

The Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program is designed to expand DDT types by encouraging development of DDTs that are out of scope for existing DDT qualification programs but may still be beneficial for drug development.

Published: Jul 31, 2025 | Category: FDA | Name: FDA Drugs

FDA Advances Drug Development Innovation by Establishing ISTAND as Permanent Qualification Program

ISTAND supports innovative, science-driven approaches that improve drug development and regulatory decision-making, ultimately helping to make therapies available to address patients’ unmet needs.

Published: Jul 31, 2025 | Category: FDA | Name: FDA Drugs

GDUFA User Fee Rates Archive

Published: Jul 30, 2025 | Category: FDA | Name: FDA Drugs

RHOPHYLAC

Routine antepartum and postpartum prevention of Rho(D) immunization in Rho(D)-negative women, for Rhesus prophylaxis in case of obstetric complications, for Rhesus prophylaxis in case of invasive procedures during pregnancy, and for the suppression of Rhesus immunization in Rho(D)-negative individua

Published: Jul 30, 2025 | Category: FDA | Name: FDA Biologics

Medical Device User Fee Small Business Qualification and Determination

This guidance updates the Small Business Guidance by describing how FDA will implement the small business registration fee waiver, among other changes.

Published: Jul 30, 2025 | Category: FDA | Name: FDA Biologics

Products Containing 7-OH Can Cause Serious Harm

The FDA recommends that consumers avoid 7-OH products, including foods, dietary supplements and those claiming to treat an ailment or disorder. 7-OH is not approved as a drug by the FDA.

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

HYQVIA

Indicated for the treatment of Primary Immunodeficiency (PI) in adults.

Published: Jul 29, 2025 | Category: FDA | Name: FDA Biologics

Field Science - Laboratory Manual

The Laboratory Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used as an agency policy for testing consumer products, training of laboratory staff, report writing, safety, research, review of private laboratory reports and cour

Published: Jul 29, 2025 | Category: FDA | Name: FDA Biologics

Laboratory Manual of Quality Policies (ISO 17025 Requirements)

Published: Jul 29, 2025 | Category: FDA | Name: FDA Biologics

Rhino 7S Type F3 7000 contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Rhino 7S Type F3 7000, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

Power Plus Desire contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Power Plus Desire, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

Platinum 69000 Rhino 69 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Platinum 69000 Rhino 69, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

Mr. Strong Guy Honey For Him contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Mr. Strong Guy Honey For Him, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

MEGA 7G 700000 contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use MEGA 7G 700000, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

XXX Zone 40K contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use XXX Zone 40K, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

Natural MiracleZEN GOLD 60000 contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Natural MiracleZEN GOLD 60000, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

Meta Forte contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Meta Forte, a product promoted and sold for sexual enhancement on various websites, and possibly in some retail stores.

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

Mega 9K 800000 contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Mega 9K 800000, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

Infinity contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Infinity, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

Infinity 10K contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Infinity 10K, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers

Published: Jul 29, 2025 | Category: FDA | Name: FDA Press Release

Hiding in Plain Sight: 7-OH Products

7-OH: Emergence of a Fourth Opioid Epidemic

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

Macsen Drugs - 698202 - 03/05/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

www.portmeds.com - 711585 - 07/16/2025

Unapproved New Drugs/Misbranded

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

www.d-pharmacy.com - 711075 - 07/16/2025

Unapproved New Drugs/Misbranded

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

Kabana Skin Care LLC - 710232 - 07/18/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

Shiva Analyticals Private Limited - 707857 - 07/23/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

www.mysteroidsmarket.com - 711353 - 07/17/2025

Unapproved New Drugs/Misbranded

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

www.plakini-pharma.com - 705185 - 07/16/2025

Unapproved New Drugs/Misbranded

Published: Jul 29, 2025 | Category: FDA | Name: FDA Drugs

FDA Recommends Removal of Voluntary Hold for Elevidys for Ambulatory Patients

Published: Jul 28, 2025 | Category: FDA | Name: FDA Press Release

Drug Trials Snapshot: AVMAPKI FAKZYNJA CO-PACK

Published: Jul 28, 2025 | Category: FDA | Name: FDA Drugs

FDA Investigating Death of 8-Year-Old Boy Who Received Elevidys

The U.S. Food and Drug Administration is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy.

Published: Jul 25, 2025 | Category: FDA | Name: FDA Press Release

Special Features

Special Features links to articles, podcasts, etc

Published: Jul 25, 2025 | Category: FDA | Name: FDA Drugs

X MAX Triple Shot Energy Honey contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use X MAX Triple Shot Energy Honey, a product promoted and sold as an energy booster on various websites, including www.amazon.com, and possibly in some retail stores.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

WeFun contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use WeFun, a product promoted and sold as an energy and performance booster on various websites, including www.amazon.com and www.eshoponlineusa.com, and possibly in some retail stores.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

Genergy contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Genergy, a product promoted and sold as an energy booster on the website www.amazon.com and possibly in some retail stores.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

FDA Electronic Drug Registration and Listing (eDRLS) using CDER Direct Training Modules

Explore training modules that deliver essential expertise for navigating FDA's electronic Drug Registration and Listing System.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

FDA Pharmaceutical Quality Training Modules

These comprehensive training modules bridge regulatory science with practical implementation.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

FDA Clinical Trials Training Modules

This training represents regulatory intelligence that sets global standards for clinical research. The content reflects current FDA thinking, emerging guidance, and real-world regulatory experience, providing participants with the most reliable and up-to-date information available.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

FDA Advancing Generic Drug Development Training Modules

This training represents regulatory expertise developed by the scientists and reviewers who evaluate ANDAs, providing access to current FDA thinking, emerging scientific approaches, and real-world application strategies that generic drug manufacturers need to succeed.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

Round 2 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Round 2, a product promoted and sold as a strength, energy, and endurance booster on various websites, including www.amazon.com, and possibly in some retail stores.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

Mens Maximum Energy Supplement contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Mens Maximum Energy Supplement, a product promoted and sold as an energy booster on the website www.amazon.com and possibly in some retail stores.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

BIG GUYS Male Energy Supplement contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use BIG GUYS Male Energy Supplement, a product promoted and sold as an energy booster on the website www.amazon.com and possibly in some retail stores.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

The Rock contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use The Rock, a product promoted and sold for sexual enhancement on various websites, and possibly in some retail stores. This product was distributed by Noah’s Wholesale, LLC.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

Ram It contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Ram It, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

T XTRA Strength Test Booster contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use T XTRA Strength Test Booster, a product promoted and sold for sexual enhancement and as an energy booster on various websites, including www.amazon.com, and possibly in some retail stores.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

TO THE MOON contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use TO THE MOON, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

Wild Bull contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Wild Bull, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

Seraphim Z contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Seraphim Z, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots: QFITLIA

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

ForeverMen contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use ForeverMen, a product promoted and sold as an energy booster on various websites, including www.amazon.com, and possibly in some retail stores. FDA laboratory analysis confirmed that ForeverMen contains sildenafil, the

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

ENDUREA contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use ENDUREA, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

Sustain® contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Sustain®, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

Schwinnng contains hidden drug ingredient

FDA is advising consumers not to purchase or use Schwinnng, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

Arize contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Arize, a product promoted and sold for sexual enhancement on various websites, including www.getarize.com, and possibly in some retail stores.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

La Paix contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use La Paix, a product promoted and sold for sexual enhancement on various websites, and possibly in some retail stores. This product was discovered during an examination of imported goods.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

Aspirin for Reducing Your Risk of Heart Attack and Stroke: Know the Facts

Information on using aspirin daily, over-the-counter, with other medicines, as well as its side effects

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

Hard Steel contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Hard Steel, a product promoted and sold for sexual enhancement on various websites, including www.hardsteelusa.com and possibly in some retail stores.

Published: Jul 24, 2025 | Category: FDA | Name: FDA Drugs

HHS, FDA and USDA Address the Health Risks of Ultra-Processed Foods

Published: Jul 23, 2025 | Category: FDA | Name: FDA Press Release

VITAFER-L Gold 10ml may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use VITAFER-L Gold 10ml, a product promoted for energy and sexual enhancement on various websites, including www.amazon.com.  

Published: Jul 23, 2025 | Category: FDA | Name: FDA Drugs

HON-E-LING may be harmful due to hidden drug ingredients

Published: Jul 23, 2025 | Category: FDA | Name: FDA Drugs

CDER Leadership Bios

Published: Jul 23, 2025 | Category: FDA | Name: FDA Drugs

Topical Antiseptic Products: Hand Sanitizers and Antibacterial Soaps

This page outlines the deferral requests and advice letters issued by FDA to manufacturers of over-the-counter (OTC) topical antiseptic products. These products are categorized as either consumer or health care and they include rubs and washes.

Published: Jul 23, 2025 | Category: FDA | Name: FDA Drugs

FATZorb may be harmful due to hidden drug ingredients

Published: Jul 22, 2025 | Category: FDA | Name: FDA Drugs

HHS, FDA Praise Consumer Brands Association’s Vow to Remove Artificial Colors from America’s Food Supply

Today the leadership of the U.S. Department of Health and Human Services (HHS) praised the Consumer Brands Association for its pledge on behalf of the makers of the nation’s food and beverage products to remove certified Food, Drug & Cosmetic (FD&C) petroleum-based colors from America’s food supply.

Published: Jul 22, 2025 | Category: FDA | Name: FDA Press Release

Commissioner's National Priority Voucher (CNPV) Pilot Program Submission

This new pilot program is designed to accelerate the development and review of certain drugs and biological products that are aligned with U.S. national health priorities and to enhance the health interests of Americans.

Published: Jul 22, 2025 | Category: FDA | Name: FDA Drugs

Commissioner's National Priority Voucher (CNPV) Pilot Program

FDA Commissioner's National Priority Voucher Program. The Commissioner's National Priority Voucher Program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months.

Published: Jul 22, 2025 | Category: FDA | Name: FDA Drugs

Missouri Analytical Laboratories Inc - 615319 - 10/09/2024

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Jul 22, 2025 | Category: FDA | Name: FDA Drugs

FDA Adverse Event Reporting System (FAERS) Electronic Submissions

This page provides drug and nonvaccine biological product manufacturers, distributors, packers, outsourcing facilities, and other interested parties with information about FDA Adverse Event Reporting System (FAERS) electronic submissions and instructions on how to electronically submit postmarketing

Published: Jul 22, 2025 | Category: FDA | Name: FDA Drugs

Nature’s Fusions LLC - 707024 - 06/25/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 22, 2025 | Category: FDA | Name: FDA Drugs

Medical Chemical Corporation - 706007 - 07/09/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 22, 2025 | Category: FDA | Name: FDA Drugs

Glenmark Pharmaceuticals Limited - 708270 - 07/11/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 22, 2025 | Category: FDA | Name: FDA Drugs

IndulgeRx Brands, Inc - 703668 - 06/16/2025

New Drug/Misbranded

Published: Jul 22, 2025 | Category: FDA | Name: FDA Drugs

O3UV, LLC - 668840 - 07/07/2025

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

Published: Jul 22, 2025 | Category: FDA | Name: FDA Biologics

Force Forever may be harmful due to hidden drug ingredients

Consumers should not to purchase or use Force Forever, a product promoted and sold for joint pain

Published: Jul 21, 2025 | Category: FDA | Name: FDA Drugs

WILDMAN may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use WILDMAN, a product promoted and sold for sexual enhancement on various websites, including www.loveproducts.net, and possibly in some retail stores.

Published: Jul 21, 2025 | Category: FDA | Name: FDA Drugs

Rhino Gummy Royal 50000 may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Rhino Gummy Royal 50000, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 21, 2025 | Category: FDA | Name: FDA Drugs

Rhino 11 Gummy may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Rhino 11 Gummy, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 21, 2025 | Category: FDA | Name: FDA Drugs

Lucky Guy Platinum 18000 may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Lucky Guy Platinum 18000, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 21, 2025 | Category: FDA | Name: FDA Drugs

Rhino 69 Gummy may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Rhino 69 Gummy, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 21, 2025 | Category: FDA | Name: FDA Drugs

X3 500K GOLD EDITION may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use X3 500K GOLD EDITION, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 21, 2025 | Category: FDA | Name: FDA Drugs

The Goat may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use The Goat, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 21, 2025 | Category: FDA | Name: FDA Drugs

RIGIDRX may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use RIGIDRX, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 21, 2025 | Category: FDA | Name: FDA Drugs

Natural MiracleZEN Platinum 70000 may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Natural MiracleZEN Platinum 70000, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 21, 2025 | Category: FDA | Name: FDA Drugs

HimGo may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use HimGo, a product promoted and sold for sexual enhancement on various websites, including ebay.com, and possibly in some retail stores.

Published: Jul 21, 2025 | Category: FDA | Name: FDA Drugs

Find Information about a Drug

Information on FDA-approved drugs released for sale on the market, such as dosage, side effects, and disposal methods

Published: Jul 21, 2025 | Category: FDA | Name: FDA Drugs

Stanford faculty member George Tidmarsh, M.D., Ph.D. named Director of Center for Drug Evaluation and Research

The U.S. Food and Drug Administration today announced the appointment of George Francis Tidmarsh, M.D., Ph.D., as Director of the Center for Drug Evaluation and Research (CDER).

Published: Jul 21, 2025 | Category: FDA | Name: FDA Press Release

FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following 3 Deaths

FDA is announcing today it has placed Elevidys and certain Sarepta investigational gene therapy clinical trials for limb girdle muscular dystrophy on clinical hold due to new safety concerns that the study participants are or would be exposed to an unreasonable and significant risk of illness or in

Published: Jul 18, 2025 | Category: FDA | Name: FDA Press Release

Regenerative Medicine Advanced Therapy Designation

Eligibility requirements for a regenerative medicine advanced therapy (RMAT) designation. Information on when and where to submit the request is also provided.

Published: Jul 18, 2025 | Category: FDA | Name: FDA Biologics

E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials

The objective of this guideline is to provide recommendations for the appropriate inclusion and/or retention of pregnant and/or breastfeeding women in clinical trials and facilitate the generation of robust clinical data that allow for evidence-based decision making on the safe and effective use of

Published: Jul 18, 2025 | Category: FDA | Name: FDA Drugs

Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry

Biosmiliars and Procedural

Published: Jul 18, 2025 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshot: IMAAVY

IMAAVY is a drug for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older. Learn more about the clinical trials.

Published: Jul 17, 2025 | Category: FDA | Name: FDA Drugs

Mark J. Savant, M.D - 712306 - 06/26/2025

Clinical Investigator

Published: Jul 17, 2025 | Category: FDA | Name: FDA Drugs

Marcus Research Laboratory, Inc. - 615153 - 10/02/2024

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Jul 16, 2025 | Category: FDA | Name: FDA Drugs

MMC Healthcare Ltd. - 684644 - 09/24/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 16, 2025 | Category: FDA | Name: FDA Drugs

Clean Solutions LLC - 686995 - 09/06/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 16, 2025 | Category: FDA | Name: FDA Drugs

Diamond Chemical Co., Inc. - 687078 - 09/06/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 16, 2025 | Category: FDA | Name: FDA Drugs

Supercore Products Group, Inc. - 690510 - 09/26/2024

CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded

Published: Jul 16, 2025 | Category: FDA | Name: FDA Drugs

Little Moon Essentials, LLC - 677260 - 09/17/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 16, 2025 | Category: FDA | Name: FDA Drugs

Makra Kozmetika D.O.O. - 684125 - 09/26/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 16, 2025 | Category: FDA | Name: FDA Drugs

FDA to Revoke 52 Obsolete Standards of Identity for Food Products

FDA is revoking, or proposing to revoke, 52 food standards after concluding they are obsolete and unnecessary.

Published: Jul 16, 2025 | Category: FDA | Name: FDA Press Release

Development of Cancer Drugs for Use in Novel Combination - Determining the Contribution of the Individual Drugs’ Effects

Published: Jul 16, 2025 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshot: VANRAFIA

Published: Jul 15, 2025 | Category: FDA | Name: FDA Drugs

FDA and Kratom

Kratom is not lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food.

Published: Jul 15, 2025 | Category: FDA | Name: FDA Drugs

Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen

This is the draft guidance Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen

Published: Jul 15, 2025 | Category: FDA | Name: FDA Biologics

Hydroxie, LLC - 709661 - 06/25/2025

Unapproved New Drug/Human Food/Adulterated

Published: Jul 15, 2025 | Category: FDA | Name: FDA Drugs

Royal Diamond Imports, Inc. - 709540 - 06/25/2025

Unapproved New Drug/Misbranded

Published: Jul 15, 2025 | Category: FDA | Name: FDA Drugs

7Tabz Retail, LLC - 709546 - 06/25/2025

Unapproved New Drugs

Published: Jul 15, 2025 | Category: FDA | Name: FDA Drugs

FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine

Published: Jul 15, 2025 | Category: FDA | Name: FDA Press Release

Covalent Medical - 695839 - 07/09/2025

Unapproved New Drugs/Misbranded

Published: Jul 15, 2025 | Category: FDA | Name: FDA Drugs

EyeTech One, LLC - 712438 - 07/09/2025

Unapproved New Drugs/Misbranded

Published: Jul 15, 2025 | Category: FDA | Name: FDA Drugs

Revitalize Energy, Inc. - 712417 - 07/09/2025

Unapproved New Drugs/Misbranded

Published: Jul 15, 2025 | Category: FDA | Name: FDA Drugs

Thea Pharma, Inc. - 712416 - 07/09/2025

Unapproved New Drugs/Misbranded

Published: Jul 15, 2025 | Category: FDA | Name: FDA Drugs

Scope Health Inc - 695085 - 07/09/2025

Unapproved New Drugs/Misbranded

Published: Jul 15, 2025 | Category: FDA | Name: FDA Drugs

Daewoo Pharmaceutical Co., Ltd. - 706371 - 07/02/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 15, 2025 | Category: FDA | Name: FDA Drugs

Mark J. Savant, M.D./San Francisco Research Institute - 712306 - 06/26/2025

Clinical Investigator

Published: Jul 15, 2025 | Category: FDA | Name: FDA Drugs

Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Announcement - 06/14/2022

This is the CBER Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Announcement.

Published: Jul 14, 2025 | Category: FDA | Name: FDA Biologics

Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement - 12/10/2020

This is the CBER Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement.

Published: Jul 14, 2025 | Category: FDA | Name: FDA Biologics

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry

Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfa

Published: Jul 14, 2025 | Category: FDA | Name: FDA Drugs

2025 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for the 2025 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (VRBPAC).

Published: Jul 14, 2025 | Category: FDA | Name: FDA Biologics

FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3

Today, the U.S. Food and Drug Administration announced it had granted Gardenia Blue Interest Group’s (GBIG) color additive petition to use the color gardenia (genipin) blue in various foods, at levels consistent with good manufacturing practice.

Published: Jul 14, 2025 | Category: FDA | Name: FDA Press Release

Gastrointestinal Drugs Advisory Committee Roster

This page contains the Gastrointestinal roster, which lists the current members and the current number of vacancies for the committee.

Published: Jul 11, 2025 | Category: FDA | Name: FDA Drugs

Psychopharmacologic Drugs Advisory Committee Roster

Published: Jul 11, 2025 | Category: FDA | Name: FDA Drugs

Peripheral and Central Nervous System Drugs Advisory Committee Roster

This page contains the Peripheral and Central Nervous System Drugs Advisory Committee Roster, which lists the current members and the current number of vacancies for the committee

Published: Jul 11, 2025 | Category: FDA | Name: FDA Drugs

Clinical Guidances

This page lists Clinical Guidance documents.

Published: Jul 11, 2025 | Category: FDA | Name: FDA Biologics

FDA Public Workshop: Future Needs for the Development of Interchangeable Products - 09/19/2025

The public meeting will be held on September 19, 2025, from 9 a.m. to 1 p.m. The meeting agenda, federal register notice, additional materials, and any other updates will also be posted to this website as they become available.

Published: Jul 11, 2025 | Category: FDA | Name: FDA Drugs

A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: 100 Days of Embracing Gold-Standard Science, Transparency and Common Sense

Statement from Commissioner Makary:100 Days of Embracing Gold-Standard Science, Transparency and Common Sense

Published: Jul 10, 2025 | Category: FDA | Name: FDA Press Release

Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals

This dataset provides a listing of all New Molecular Entities (NMEs) approved from 1985 – 2019 and regulated by the Center for Drug Evaluation and Research (CDER). The listed NMEs include both small molecule drugs approved under a New Drug Application (NDA) and new biological products approved under

Published: Jul 10, 2025 | Category: FDA | Name: FDA Drugs

FDA Embraces Radical Transparency by Publishing Complete Response Letters

The FDA today published more than 200 decision letters, known as complete response letters (CRLs).

Published: Jul 10, 2025 | Category: FDA | Name: FDA Press Release

FDA Encourages Industry Leaders to Streamline, Enhance Product Recall Communications to Safeguard Foods for Infants and Children

The U.S. Food and Drug Administration encourages industry leaders involved in manufacturing and distribution of infant formula, baby foods, and foods intended for children to streamline and enhance product recall communications.

Published: Jul 9, 2025 | Category: FDA | Name: FDA Press Release

Compounding Quality Center of Excellence | Annual Conference - 08/25/2025

FDA’s Compounding Quality Center of Excellence will host its sixth Annual Conference, August 27 and 28, 2025. Participants can attend this free, hybrid conference in person at the Bethesda North Marriott Hotel & Conference Center in North Bethesda, Md., or virtually.

Published: Jul 9, 2025 | Category: FDA | Name: FDA Drugs

Compounding Quality Center of Excellence | Annual Conference

Compounding Quality Center of Excellence Virtual Conference

Published: Jul 9, 2025 | Category: FDA | Name: FDA Drugs

Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks

Category 2 of the Bulk Substances Nominated Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act

Published: Jul 8, 2025 | Category: FDA | Name: FDA Drugs

Black Horse Miracle Honey for Men may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Black Horse Miracle Honey for Men, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 8, 2025 | Category: FDA | Name: FDA Drugs

Secret Miracle Honey Extra Strength may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Secret Miracle Honey Extra Strength, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 8, 2025 | Category: FDA | Name: FDA Drugs

Black Panther Miracle Honey for Men may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Black Panther Miracle Honey for Men, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 8, 2025 | Category: FDA | Name: FDA Drugs

Versace Real Honey for Men may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Versace Real Honey for Men, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Jul 8, 2025 | Category: FDA | Name: FDA Drugs

FDA Grand Rounds – Forensic Proteomics Applied to FDA-Regulated Products - 07/31/2025

Forensic Proteomics Applied to FDA-Regulated Products, July 31, 2025

Published: Jul 8, 2025 | Category: FDA | Name: FDA Biologics

Libby Laboratories, Inc. - 708259 - 06/27/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 8, 2025 | Category: FDA | Name: FDA Drugs

Xtreme Tools International, Inc. - 706053 - 06/25/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 8, 2025 | Category: FDA | Name: FDA Drugs

Dynamic Blending Specialists, Inc. - 701278 - 06/18/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 8, 2025 | Category: FDA | Name: FDA Drugs

Biosimilars | Science and Research

Learn about FDA’s latest in biosimilar science and research.

Published: Jul 8, 2025 | Category: FDA | Name: FDA Drugs

Biosimilars Research: Awards

Published: Jul 7, 2025 | Category: FDA | Name: FDA Drugs

FDA Public Meeting: BsUFA III Regulatory Science Program Interim Public Meeting - 09/18/2025

The U.S. Food and Drug Administration (FDA) is hosting a hybrid in-person/virtual meeting on September 18, 2025, to meet the BsUFA III Commitment to review the progress of the pilot program’s aims, or demonstration projects, and solicit input on future priorities.

Published: Jul 7, 2025 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshot: ROMVIMZA

The FDA approved ROMVIMZA based on safety and efficacy evidence from one clinical trial (NCT05059262) of 123 patients with TGCT. Learn more about the trial.

Published: Jul 7, 2025 | Category: FDA | Name: FDA Drugs

Endothelin Receptor Antagonist REMS Information

FDA has determined that a REMS is no longer necessary to ensure ERA medicines’ benefits outweigh the risk of EFT.

Published: Jul 7, 2025 | Category: FDA | Name: FDA Drugs

Check Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers

Prescription drugs should only be purchased from wholesale drug distributors licensed in the United States. Verify licensing through FDA database links.

Published: Jul 7, 2025 | Category: FDA | Name: FDA Drugs

Exela Pharma Sciences, LLC - 709859 - 07/02/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 3, 2025 | Category: FDA | Name: FDA Drugs

FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

On July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertio

Published: Jul 2, 2025 | Category: FDA | Name: FDA Drugs

Novel Drug Approvals for 2023

Each year, CDER approves a wide range of new drugs and biological products.

Published: Jul 2, 2025 | Category: FDA | Name: FDA Drugs

Extended-Release Stimulants for ADHD: FDA Drug Safety Communication - FDA Requires Expanded Labeling about Weight Loss Risk in Patients Younger than 6 Years

The FDA is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) - including certain formulations of amphetamine and methylphenidate - to warn about the risk of weight loss and other adverse reactions (side effects) in patients yo

Published: Jul 2, 2025 | Category: FDA | Name: FDA Drugs

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

The FDA maintains a list of approved new drug application (NDA) drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an ANDA referencing that NDA drug product.

Published: Jul 2, 2025 | Category: FDA | Name: FDA Drugs

KYMRIAH

KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse

Published: Jul 2, 2025 | Category: FDA | Name: FDA Biologics

FLULAVAL

Active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. FLULAVAL is approved for use in persons 6 months of age and older.

Published: Jul 2, 2025 | Category: FDA | Name: FDA Biologics

FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma

Published: Jul 2, 2025 | Category: FDA | Name: FDA Drugs

Fluarix

For active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. FLUARIX is approved for use in persons aged 6 months and older.

Published: Jul 2, 2025 | Category: FDA | Name: FDA Biologics

Drug Trials Snapshots: DATROWAY

Published: Jul 2, 2025 | Category: FDA | Name: FDA Drugs

Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment

Published: Jul 2, 2025 | Category: FDA | Name: FDA Drugs

State Importation Program Enhancements

FDA is committed to continuing to work with states and Indian tribes that seek to develop an importation proposal under section 804 of the Federal Food, Drug and Cosmetic Act.

Published: Jul 2, 2025 | Category: FDA | Name: FDA Drugs

Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations

Published: Jul 2, 2025 | Category: FDA | Name: FDA Drugs

FLUCELVAX

For active immunization of persons 4 years of age and older for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

Published: Jul 1, 2025 | Category: FDA | Name: FDA Biologics

FluMist

For the active immunization of individuals 2-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

Published: Jul 1, 2025 | Category: FDA | Name: FDA Biologics

"Peter Michael, M.D. - 711299 - 06/18/2025

Clinical Investigator

Published: Jul 1, 2025 | Category: FDA | Name: FDA Drugs

Healwell Homeo Private Limited - 706206 - 06/12/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jul 1, 2025 | Category: FDA | Name: FDA Drugs

www.buynetmeds.com - 706335 - 06/12/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Published: Jul 1, 2025 | Category: FDA | Name: FDA Drugs

InVia Fertility Specialists, PLLC - 710632 - 06/13/2025

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Jul 1, 2025 | Category: FDA | Name: FDA Biologics

Staska Pharmaceuticals, Inc. - 699291 - 05/05/2025

Compounding Pharmacy/Adulterated Drug Products

Published: Jul 1, 2025 | Category: FDA | Name: FDA Drugs

FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD

Published: Jun 30, 2025 | Category: FDA | Name: FDA Drugs

GAMMAGARD LIQUID

Product approval information is indicated for: • Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older. • Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).

Published: Jun 30, 2025 | Category: FDA | Name: FDA Biologics

Ultra Seal Corporation - 624650 - 09/25/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 30, 2025 | Category: FDA | Name: FDA Drugs

Azurity Pharmaceuticals, Inc. - 656489 - 09/20/2024

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

Published: Jun 30, 2025 | Category: FDA | Name: FDA Drugs

Nomida.biz - 687590 - 09/12/2024

Unapproved New Drugs/Misbranded

Published: Jun 30, 2025 | Category: FDA | Name: FDA Drugs

Aerosol and Liquid Packaging, Inc. - 676746 - 07/24/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 30, 2025 | Category: FDA | Name: FDA Drugs

Media Networks Sydney Pty Limited - 687044 - 09/18/2024

Failure to Register and List

Published: Jun 30, 2025 | Category: FDA | Name: FDA Drugs

Accupack Midwest, Inc. - 680228 - 08/15/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 30, 2025 | Category: FDA | Name: FDA Drugs

January - March 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Published: Jun 30, 2025 | Category: FDA | Name: FDA Drugs

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial.

Published: Jun 27, 2025 | Category: FDA | Name: FDA Drugs

MNEXSPIKE

For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). MNEXSPIKE is approved for use in individuals who have been previously vaccinated with any COVID-19 vaccine and are: • 65 years of age and older, or • 12 thro

Published: Jun 27, 2025 | Category: FDA | Name: FDA Biologics

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies

Published: Jun 27, 2025 | Category: FDA | Name: FDA Press Release

TECARTUS

For the treatment of adult patients with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (B-ALL). For the treatment of adult patients with relapsed/refractory mantle cell lymphoma (r/r MCL).

Published: Jun 27, 2025 | Category: FDA | Name: FDA Biologics

YESCARTA

For the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Axicabtagene ciloleucel is not indicated for the treatment of patients with primary central nervous system lymphoma.

Published: Jun 27, 2025 | Category: FDA | Name: FDA Biologics

OMUFA Performance Reports

Over-the-Counter Monograph Drug User Fee annual performance reports to Congress

Published: Jun 27, 2025 | Category: FDA | Name: FDA Drugs

ABECMA (idecabtagene vicleucel)

Published: Jun 27, 2025 | Category: FDA | Name: FDA Biologics

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies

The REMS for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies have been eliminated because the FDA has determined that a REMS is no longer necessary.

Published: Jun 26, 2025 | Category: FDA | Name: FDA Biologics

CARVYKTI

For the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

Published: Jun 26, 2025 | Category: FDA | Name: FDA Biologics

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

Published: Jun 26, 2025 | Category: FDA | Name: FDA Biologics

PDUFA and BsUFA Quarterly Hiring Updates

Published: Jun 26, 2025 | Category: FDA | Name: FDA Drugs

Unique Device Identifier Requirements for Combination Products

Draft guidance to assist industry and FDA staff in understanding how FDA’s unique device identifier (UDI) requirements apply to combination products with device constituent parts, and outline requirements and recommendations for UDI labeling and submission of information to the GUDID database

Published: Jun 26, 2025 | Category: FDA | Name: FDA Drugs

LEC Custom Products, Inc. - 607838 - 06/18/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 26, 2025 | Category: FDA | Name: FDA Drugs

Conducting Remote Regulatory Assessments Questions and Answers

Conducting Remote Regulatory Assessments Questions and Answers Guidance for Industry

Published: Jun 26, 2025 | Category: FDA | Name: FDA Drugs

LEC Custom Products, Inc. - 607838 - 09/24/2020

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 26, 2025 | Category: FDA | Name: FDA Drugs

mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination

Published: Jun 26, 2025 | Category: FDA | Name: FDA Biologics

Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers

Published: Jun 26, 2025 | Category: FDA | Name: FDA Drugs

ELEVIDYS

Treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.

Published: Jun 25, 2025 | Category: FDA | Name: FDA Biologics

Information for Consumers and Patients | Drugs

Drug Information for Patients and Consumers

Published: Jun 25, 2025 | Category: FDA | Name: FDA Drugs

Labeling for CBER-Regulated Products

Published: Jun 25, 2025 | Category: FDA | Name: FDA Biologics

SPIKEVAX

COVID19 Vaccine, mRNA

Published: Jun 25, 2025 | Category: FDA | Name: FDA Biologics

COMIRNATY

COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.

Published: Jun 25, 2025 | Category: FDA | Name: FDA Biologics

Drug Trials Snapshots: IOMERVU

IOMERVU is a radiographic contrast agent that is used during an arteriogram to visualize blood vessels in adult and pediatric patients. IOMERVU is also used during computed tomography (CT) imaging to visualize organs and lesions in the head, body, and urinary system.

Published: Jun 25, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination

FDA has required and approved updates to the Prescribing Information for Comirnaty manufactured by Pfizer Inc. and Spikevax manufactured ModernaTX, Inc. to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines.

Published: Jun 25, 2025 | Category: FDA | Name: FDA Biologics

Drug Trials Snapshot: ALYFTREK

Published: Jun 25, 2025 | Category: FDA | Name: FDA Drugs

FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes

The U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors.

Published: Jun 25, 2025 | Category: FDA | Name: FDA Drugs

For Healthcare Professionals | FDA’s Examples of Drugs that Interact with CYP Enzymes and Transporter Systems

FDA’s Examples of Interacting Drugs and Other Substances Involving CYP Metabolic- and Transporter System-Based Pathways for Healthcare Professionals

Published: Jun 25, 2025 | Category: FDA | Name: FDA Drugs

Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment

Published: Jun 25, 2025 | Category: FDA | Name: FDA Drugs

Toki Slimming Candy may be harmful due to hidden drug ingredients

Toki Slimming Candy may be harmful due to hidden drug ingredients. The Food and Drug Administration is advising consumers not to purchase or use Toki Slimming Candy, a product promoted and sold for weight loss on various websites, including www.eBay.com, and possibly in some retail stores.

Published: Jun 24, 2025 | Category: FDA | Name: FDA Drugs

FDA Investigating Deaths Due to Acute Liver Failure in Non-ambulatory Duchenne Muscular Dystrophy Patients Following ELEVIDYS

Since approval, the FDA has received two reports of fatal acute liver failure following treatment of non-ambulatory pediatric male patients with DDMD with ELEVIDYS, an adeno-associated virus vector-based gene therapy.

Published: Jun 24, 2025 | Category: FDA | Name: FDA Biologics

FIBRYGA

For the treatment of acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Published: Jun 24, 2025 | Category: FDA | Name: FDA Biologics

Pfizer-BioNTech COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) Authorized For Individuals 6 Months through 11 Years of Age

Published: Jun 24, 2025 | Category: FDA | Name: FDA Biologics

Moderna COVID-19 Vaccine

Information about Moderna COVID-19 Vaccine, Bivalent. Updated, bivalent mRNA COVID-19 vaccines are now FDA-authorized for all doses for individuals ages 6 months and older.

Published: Jun 24, 2025 | Category: FDA | Name: FDA Biologics

Laboratory Information Bulletins

Laboratory Information Bulletins available to the public

Published: Jun 24, 2025 | Category: FDA | Name: FDA Drugs

Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. Sirketi - 709156 - 06/16/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 24, 2025 | Category: FDA | Name: FDA Drugs

www.soma4ever.com - 706082 - 06/13/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Published: Jun 24, 2025 | Category: FDA | Name: FDA Drugs

Sterling Distributors - 706508 - 06/05/2025

Drug Supply Chain Security Act (DSCSA) Violations

Published: Jun 24, 2025 | Category: FDA | Name: FDA Drugs

www.peacefulmeds.com - 703470 - 05/05/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Published: Jun 24, 2025 | Category: FDA | Name: FDA Drugs

Questions about Vaccines

Information on general and specific vaccines

Published: Jun 24, 2025 | Category: FDA | Name: FDA Biologics

EnviroServe Chemicals & Cleaners Ltd. - 674090 - 09/09/2024

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/Misbranded

Published: Jun 23, 2025 | Category: FDA | Name: FDA Drugs

Greco Gas, Inc. - 683090 - 08/12/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 23, 2025 | Category: FDA | Name: FDA Drugs

Zen Enterprises LLC - 678407 - 09/11/2024

Failure to Register and List

Published: Jun 23, 2025 | Category: FDA | Name: FDA Drugs

Torrent Pharmaceuticals Limited - 585255 - 09/04/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 23, 2025 | Category: FDA | Name: FDA Drugs

Tan-Alize Kozmetick ve Temizlik Urunleri Sanayi ve Ticaret A.S. - 659854 - 08/14/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 23, 2025 | Category: FDA | Name: FDA Drugs

Eco Lips, Inc. - 631629 - 08/22/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 23, 2025 | Category: FDA | Name: FDA Drugs

Media Networks Sydney Pty Limited - 687044 - 08/15/2024

Failure to Register and List

Published: Jun 23, 2025 | Category: FDA | Name: FDA Drugs

Intercos Europe S.p.A - 682273 - 08/15/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 23, 2025 | Category: FDA | Name: FDA Drugs

Eugia Pharma Specialities Limited - 681905 - 08/15/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 23, 2025 | Category: FDA | Name: FDA Drugs

Velocity Pharma LLC - 676434 - 07/17/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 23, 2025 | Category: FDA | Name: FDA Drugs

Omega Tech Labs LLC - 679700 - 07/23/2024

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

Published: Jun 23, 2025 | Category: FDA | Name: FDA Drugs

Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. - 675823 - 08/01/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 23, 2025 | Category: FDA | Name: FDA Drugs

FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer

On June 23, 2025, the Food and Drug Administration granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

Published: Jun 23, 2025 | Category: FDA | Name: FDA Drugs

Ongoing Clinical Oncology Projects

Clinical projects of the Oncology Center of Excellence, 2023 Annual Report

Published: Jun 23, 2025 | Category: FDA | Name: FDA Drugs

Q1 Stability Testing of Drug Substances and Drug Products

This draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Published: Jun 23, 2025 | Category: FDA | Name: FDA Drugs

October 10, 2024: Meeting of the Cardiovascular and Renal Drugs Advisory Committee - 10/10/2024

The Committee will discuss new drug application (NDA) 215244, for elamipretide hydrochloride injection, submitted by Stealth BioTherapeutics Inc., for the treatment of Barth Syndrome.

Published: Jun 20, 2025 | Category: FDA | Name: FDA Drugs

PREA Non-Compliance Letters

Published: Jun 20, 2025 | Category: FDA | Name: FDA Biologics

DG Gel Card 125445, 125449, 125450 - 125457

Product approval information is for: •DG Gel 8 AB (x4) card is for the determination of human A and B antigen on the surface of red blood cells in four separate blood samples. For use with the DG Gel System. For in vitro diagnostic use. •DG Gel 8 A/B/D card is for the determination of human A, B and

Published: Jun 20, 2025 | Category: FDA | Name: FDA Biologics

Transderm Scōp (Scopolamine Transdermal System): Drug Safety Communication - FDA Adds Warning About Serious Risk of Heat-Related Complications with Antinausea Patch

The FDA is warning that the antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases. Most cases occurred in children 17 years and younger and in adults 60 years and o

Published: Jun 20, 2025 | Category: FDA | Name: FDA Drugs

Pharmaceutical Quality Resources

FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance documents, and compliance programs.

Published: Jun 20, 2025 | Category: FDA | Name: FDA Drugs

News from Emerging Technology Program (ETP)

CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.

Published: Jun 20, 2025 | Category: FDA | Name: FDA Drugs

FDA Halts New Clinical Trials That Export Americans’ Cells to Foreign Labs in Hostile Countries for Genetic Engineering

Published: Jun 18, 2025 | Category: FDA | Name: FDA Press Release

FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma

On June 18, 2025, the Food and Drug Administration approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).

Published: Jun 18, 2025 | Category: FDA | Name: FDA Drugs

FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Scōp (scopolamine transdermal system)

The antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases.

Published: Jun 18, 2025 | Category: FDA | Name: FDA Drugs

PRIVIGEN

For the treatment of: Primary humoral immunodeficiency (PI) Chronic immune thrombocytopenic purpura (ITP) in patients age 15 years and older Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults

Published: Jun 18, 2025 | Category: FDA | Name: FDA Biologics

Post-Warning Letter Meetings Under GDUFA

Published: Jun 18, 2025 | Category: FDA | Name: FDA Drugs

2025 Meeting Materials, Psychopharmacologic Drugs Advisory Committee

Published: Jun 17, 2025 | Category: FDA | Name: FDA Drugs

July 18, 2025: Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement - 07/18/2025

July 18, 2025: Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement

Published: Jun 17, 2025 | Category: FDA | Name: FDA Drugs

FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests

The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans.

Published: Jun 17, 2025 | Category: FDA | Name: FDA Press Release

Xenotransplantation Guidances

This page contains a listing of xenotransplantation guidances.

Published: Jun 17, 2025 | Category: FDA | Name: FDA Biologics

Vaccine and Related Biological Product Guidances

This page contains a listing of vaccine and related biological product guidances

Published: Jun 17, 2025 | Category: FDA | Name: FDA Biologics

Clinical Outcome Assessment (COA) Qualification Program: Frequently Asked Questions

CDER Clinical Outcome Assessments (COA) Qualification Program: Frequently Asked Questions (FAQs)

Published: Jun 17, 2025 | Category: FDA | Name: FDA Drugs

Cellular & Gene Therapy Guidances

This page contains a listing of cellular and gene therapy guidances.

Published: Jun 17, 2025 | Category: FDA | Name: FDA Biologics

Qualified Clinical Outcome Assessments (COA)

The table below lists qualified Clinical Outcome Assessments (COA). The tables include legacy projects (those submitted prior to passage of the 21st Century Cures Act), as well as those submitted as part of the newer section 507 process (referring to section 507 of the Federal Food, Drug and Cosmeti

Published: Jun 17, 2025 | Category: FDA | Name: FDA Drugs

FDA's ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience

Published: Jun 17, 2025 | Category: FDA | Name: FDA Drugs

Resources for Biomarker Requestors

Information and resources for requestors about FDA’s Biomarker Qualification Program

Published: Jun 17, 2025 | Category: FDA | Name: FDA Drugs

Clinical Outcome Assessments (COA) Qualification Program Resources

Resources and information for requestors interested in CDER’s Clinical Outcome Assessments (COA) Qualification Program. This update contains the Letter of Intent Template for the COA Qualification Program, as described under section 507 of the Federal Food, Drug, and Cosmetic Act.

Published: Jun 17, 2025 | Category: FDA | Name: FDA Drugs

Clinical Outcome Assessments (COA) Qualification Program Submissions

Published: Jun 17, 2025 | Category: FDA | Name: FDA Drugs

Animal Model Qualification Program | AMQP

Information for requestors interested in submitting animal models for qualification to FDA’s Drug Development Tool (DDT) Programs.

Published: Jun 17, 2025 | Category: FDA | Name: FDA Drugs

Drug Development Tool Qualification Process: Transparency Provisions

Under the 21st Century Cures Act enacted on December 13, 2016, the new section 507 Qualification of Drug Development Tools was added to the Federal Food, Drug, and Cosmetic Act and formally establishes an updated, multi-stage process for DDT qualification. This process includes three submission mil

Published: Jun 17, 2025 | Category: FDA | Name: FDA Drugs

Blood Guidances

This page contains a listing of Blood Guidances guidances.

Published: Jun 17, 2025 | Category: FDA | Name: FDA Biologics

Allergenics Guidances

This page contains a listing of Allergenics Guidance documents.

Published: Jun 17, 2025 | Category: FDA | Name: FDA Biologics

www.bigpharmausa.com - 702681 - 06/04/2025

Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet

Published: Jun 17, 2025 | Category: FDA | Name: FDA Drugs

www.24hreup.biz - 700358 - 04/23/2025

Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet

Published: Jun 17, 2025 | Category: FDA | Name: FDA Drugs

www.buyprosoma.com - 705973 - 06/10/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Published: Jun 17, 2025 | Category: FDA | Name: FDA Drugs

www.buycodeine.us - 702527 - 05/05/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Published: Jun 17, 2025 | Category: FDA | Name: FDA Drugs

Kenil Healthcare Private Limited - 704786 - 06/12/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 17, 2025 | Category: FDA | Name: FDA Drugs

Pulmonary-Allergy Drugs Advisory Committee Roster

This page contains the Pulmonary-Allergy Drugs Advisory Committee roster, which lists the current members and the current number of vacancies for the committee.

Published: Jun 16, 2025 | Category: FDA | Name: FDA Drugs

What's New in Regulatory Science

A newsletter on regulatory science for CDER's stakeholders

Published: Jun 16, 2025 | Category: FDA | Name: FDA Drugs

Testing Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases

Testing HCT/P Donors for Relevant Communicable Diseases

Published: Jun 13, 2025 | Category: FDA | Name: FDA Biologics

Pharmacy Compounding Advisory Committee Roster

This page contains the PCAC roster, which lists the current members and the current number of vacancies for the committee.

Published: Jun 13, 2025 | Category: FDA | Name: FDA Drugs

UPDATED: Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer & Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Due to Presence of Methanol

Canton, SD, Jarman’s Midwest Cleaning Systems, Inc. is voluntarily recalling all lots of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution and Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution to the consumer level. FDA testing found the

Published: Jun 13, 2025 | Category: FDA | Name: FDA Drugs

MRESVIA

Rolling BLA (Part 1 of 2) - Active immunization for the prevention of lower respiratory tract disease (LRTD) and acute respiratory disease (ARD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.

Published: Jun 13, 2025 | Category: FDA | Name: FDA Biologics

FDA Rare Disease Innovation Hub

FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.

Published: Jun 13, 2025 | Category: FDA | Name: FDA Biologics

ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions

Published: Jun 13, 2025 | Category: FDA | Name: FDA Drugs

FDA approves neoadjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma

On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent

Published: Jun 12, 2025 | Category: FDA | Name: FDA Drugs

2025 Biological License Application Approvals

Listing of the 2025 Biological License Application Approvals

Published: Jun 12, 2025 | Category: FDA | Name: FDA Biologics

ANDA Assessment Program | GDUFA III Performance Goals and Program Enhancements

GDUFA III includes several enhancements to the ANDA assessment process to maximize the efficiency and utility of each assessment cycle. These enhancements aim to reduce the number of assessment cycles and facilitate timely access to safe, effective, high-quality, and affordable generics.

Published: Jun 12, 2025 | Category: FDA | Name: FDA Drugs

Submit a Standardized Data Sample to FDA

FDA would like to assist sponsors and applicants who have not previously submitted an eCTD and/or standardized study data, and who are planning a submission to the FDA. We offer a process to validate sample eCTD submissions and standardized study datasets.

Published: Jun 12, 2025 | Category: FDA | Name: FDA Drugs

Submit an eCTD v4.0 or Standardized Data Sample to the FDA

Learn more about FDA's process to validate sample new eCTD v4.0 submissions and standardized study datasets.

Published: Jun 12, 2025 | Category: FDA | Name: FDA Drugs

Electronic Regulatory Submission and Review

This page provides information about the electronic submission of regulatory information to the Center and the review of it by CDER staff.

Published: Jun 12, 2025 | Category: FDA | Name: FDA Drugs

FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer

On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Published: Jun 12, 2025 | Category: FDA | Name: FDA Drugs

Compliance Programs (CBER)

List of biological CBER compliance programs

Published: Jun 12, 2025 | Category: FDA | Name: FDA Biologics

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration - 05/20/2025

OTC Monograph Drug User Fee Program (OMUFA); Understanding FY 2025 User Fees and Registration

Published: Jun 11, 2025 | Category: FDA | Name: FDA Drugs

FDA approves taletrectinib for ROS1-positive non-small cell lung cancer

On June 11, 2025, the Food and Drug Administration approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Published: Jun 11, 2025 | Category: FDA | Name: FDA Drugs

CDER Staff Member Shares Her Experience in a Breast Cancer Clinical Trial

She was overwhelmed, but she felt the trial was her best chance for a successful outcome.

Published: Jun 11, 2025 | Category: FDA | Name: FDA Drugs

C3TI Demonstration Program

Provides the opportunity to test, implement, and scale the integration of innovation into clinical trials through increased communication and interaction between CDER and sponsors of innovative clinical trials in certain project areas

Published: Jun 11, 2025 | Category: FDA | Name: FDA Drugs

C3TI Demonstration Program Proposal Submission

Submitting content and format of the C3TI Demonstration Program Proposal

Published: Jun 11, 2025 | Category: FDA | Name: FDA Drugs

Selective Safety Data Collection (SSDC) Demonstration Project

Offers an innovative approach to facilitate the conduct of large-scale efficacy and safety trials through the purposeful reduction in the collection of certain types of data for drugs or biologics with a well-characterized safety profile.

Published: Jun 11, 2025 | Category: FDA | Name: FDA Drugs

Streamlined Trials Embedded in clinical Practice (STEP) Demonstration Project

C3TI aims to promote the adoption of pragmatic design in clinical trials and improve coordination and collaboration between CDER and sponsors to effectively support these innovative trials.

Published: Jun 11, 2025 | Category: FDA | Name: FDA Drugs

Bayesian Statistical Analysis (BSA) Demonstration Project

C3TI aims to increase experience in Bayesian statistical methods in simple trial settings across sponsors, CDER clinical reviewers, and CDER statisticians, including deepening an understanding of their applicability, opportunities, and challenges.

Published: Jun 11, 2025 | Category: FDA | Name: FDA Drugs

Real-World Evidence Submissions to the Center for Drug Evaluation and Research

As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions.

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

Sleep, Skin and Bodybuilding Product Notifications

Learn about the warnings for sleep, skin and bodybuilding products that contain hidden drugs and other hidden ingredients.

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

Sexual Enhancement and Energy Product Notifications

Learn about the warnings for sexual enhancement and energy products that contain hidden drugs and other hidden ingredients.

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

Amish Origins Management, LLC - 704166 - 05/29/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

American Behavioral Research Institute, LLC - 705629 - 04/30/2025

Clinical Investigator (Sponsor)

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

Sprout Pharmaceuticals, Inc. - 709942 - 05/29/2025

False & Misleading Claims/Misbranded

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

Laboratoire Druide Inc. - 705517 - 05/29/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

Bio Wellness 444 LLC - 709333 - 05/30/2025

Unapproved New Drugs/Misbranded

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

Common Questions about Medication Health Fraud

Find answers to the most asked questions about medication health fraud and how to identify scams when buying products.

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

Pain and Arthritis Products Containing Hidden Ingredients

Learn about the warnings for pain and arthritis products that contain hidden drugs and other hidden ingredients.

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

Weight Loss Product Notifications

Learn about the warnings for weight loss products that contain hidden drugs and other hidden ingredients.

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

Talking to Your Patients about Medication Health Fraud

Health care providers can make personalized recommendations and help ensure that patients and consumers are accessing safe and effective treatments.

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

Help Others Stay Safe from Medication Health Fraud

Talk to friends and family about medication health fraud. Share FDA’s resources on ways to stay vigilant when buying products and supplements.

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

Avoiding Products Contaminated with Hidden Ingredients

Many products claiming to help with health issues hide dangerous drug ingredients. Get informed about how to avoid contaminated products and their hidden ingredients.

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

Medication Health Fraud Notifications

FDA has found more than 1,000 products that make false or unproven claims to help with health issues and/or are contaminated with dangerous hidden ingredients.

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

Medication Health Fraud

Medication health fraud includes marketing of products and supplements that have not been proven effective and make false claims.

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

Medication Health Fraud Resources for Health Care Professionals

Supplement use is at an all-time high, so health care professionals must help educate their patients about medication health fraud and other health scams.

Published: Jun 10, 2025 | Category: FDA | Name: FDA Drugs

Center for Biologics Evaluation and Research & Center for Drug Evaluation and Research Real-World Evidence

As defined by FDA, real-world data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources and real-world evidence (RWE) is the clinical evidence regarding a medical product’s use and potential benefits or risks derived fr

Published: Jun 9, 2025 | Category: FDA | Name: FDA Drugs

Real-World Evidence

Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data to support regulatory decision making.

Published: Jun 9, 2025 | Category: FDA | Name: FDA Drugs

Advancing Real-World Evidence Program

Published: Jun 9, 2025 | Category: FDA | Name: FDA Drugs

Real-World Evidence Submissions to the Center for Biologics Evaluation and Research & the Center for Drug Evaluation and Research

As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).

Published: Jun 9, 2025 | Category: FDA | Name: FDA Drugs

Church & Dwight Co., Inc. Issues Voluntary Nationwide Recall of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs Due to Microbial Contamination

Church & Dwight Co., Inc. is voluntarily recalling all lots within expiry of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs to the consumer level.

Published: Jun 7, 2025 | Category: FDA | Name: FDA Drugs

Electronic Registration and Listing Compliance Program

Establishment registration and drug listing data is submitted by drug manufacturers and own label drug distributors through electronic means using Structured Product Labeling format (SPL).

Published: Jun 6, 2025 | Category: FDA | Name: FDA Drugs

2023 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee

This page contains the meeting materials for the Cardiovascular &amp; Renal Drugs Advisory Committee meetings for 2023.

Published: Jun 5, 2025 | Category: FDA | Name: FDA Drugs

M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol

Published: Jun 5, 2025 | Category: FDA | Name: FDA Drugs

M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)

Clinical Electronic Structured Harmonised Protocol

Published: Jun 5, 2025 | Category: FDA | Name: FDA Drugs

Amneal Pharmaceutical LLC Issues a Nationwide Recall of Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80 mg Only, Due to Microbial Contamination

Amneal Pharmaceutical LLC, is recalling three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg to the consumer level as the tablets may exhibit black spots on the tablet surface due to microbial contamination. The observance of black spots was reported in a product quality complaint

Published: Jun 4, 2025 | Category: FDA | Name: FDA Drugs

Considerations for Including Tissue Biopsies in Clinical Trials

Considerations for Including Tissue Biopsies in Clinical Trials; Guidance for Industry, Investigators, Institutions, and Institutional Review Boards

Published: Jun 4, 2025 | Category: FDA | Name: FDA Biologics

Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction

This guidance provides recommendations to industry regarding the development of drugs and biological products regulated within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance of body weight in patients with obesity or overweight.

Published: Jun 4, 2025 | Category: FDA | Name: FDA Drugs

New Drug Therapy Approvals 2022

Showcases our role in bringing drug therapies to patients that are safe and effective

Published: Jun 4, 2025 | Category: FDA | Name: FDA Drugs

Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers

This draft guidance provides information on the most frequently asked questions regarding transfer of ownership from one 510(k) holder to another.

Published: Jun 4, 2025 | Category: FDA | Name: FDA Biologics

Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs

This guidance provides recommendations for how requestors can comply with the requirements described in the Proposed Administrative Order titled Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs.

Published: Jun 4, 2025 | Category: FDA | Name: FDA Drugs

Novel Drug Approvals for 2024

Innovative drugs often mean new treatment options for patients and advances in health care for the American public.

Published: Jun 4, 2025 | Category: FDA | Name: FDA Drugs

FDA approves darolutamide for metastatic castration-sensitive prostate cancer

On June 3, 2025, the Food and Drug Administration (FDA) approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC).

Published: Jun 3, 2025 | Category: FDA | Name: FDA Drugs

BsUFA III Regulatory Science Pilot Program: Progress Update - 01/22/2025

BsUFA III Regulatory Science Pilot Program: Progress Update

Published: Jun 3, 2025 | Category: FDA | Name: FDA Drugs

Generic Drugs Program 2024 Fiscal Year Web Posting

Published: Jun 3, 2025 | Category: FDA | Name: FDA Drugs

Amy Lightner MD - 682593 - 05/06/2025

Bioresearch Monitoring Program

Published: Jun 3, 2025 | Category: FDA | Name: FDA Biologics

Rechon Life Science AB - 701040 - 04/30/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 3, 2025 | Category: FDA | Name: FDA Drugs

CTK OTC Laboratories LLC formerly FMK LABS, Inc. - 705479 - 05/19/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 3, 2025 | Category: FDA | Name: FDA Drugs

Huangshi Hygienic Material Medicine Co., Ltd. - 700658 - 03/24/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 3, 2025 | Category: FDA | Name: FDA Drugs

Zhejiang Easyclean Daily Chemical Co., Ltd - 702295 - 05/14/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 3, 2025 | Category: FDA | Name: FDA Drugs

Mother Earth Minerals, Inc. - 692527 - 03/28/2025

Unapproved New Drugs/Misbranded

Published: Jun 3, 2025 | Category: FDA | Name: FDA Drugs

Evi Labs LLC - 705846 - 05/14/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 3, 2025 | Category: FDA | Name: FDA Drugs

Yiling Pharmaceutical Ltd. - 699738 - 03/27/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Jun 3, 2025 | Category: FDA | Name: FDA Drugs

FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People

The U.S. Food and Drug Administration (FDA) today launched Elsa, a generative Artificial Intelligence (AI) tool designed to help employees—from scientific reviewers to investigators—work more efficiently.

Published: Jun 2, 2025 | Category: FDA | Name: FDA Press Release

Completed PDUFA VII Deliverables

Since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, user fees have played an important role in expediting the drug approval process while ensuring their safety and efficacy. PDUFA must be reauthorized every five years, and in September 2022, the President signed into law the six

Published: Jun 2, 2025 | Category: FDA | Name: FDA Drugs

CBER Rare Disease Program Frequently Asked Questions

Published: Jun 2, 2025 | Category: FDA | Name: FDA Biologics

Recalls (Biologics)

Biologic recalls are listed by year. Recalls are a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action.

Published: Jun 2, 2025 | Category: FDA | Name: FDA Biologics

Over-the-Counter OTC | Nonprescription Drugs

Over-the-counter (OTC) drugs are developed under the OTC Monograph Process or through the New Drug Application (NDA) Process.

Published: Jun 2, 2025 | Category: FDA | Name: FDA Drugs

Postmarketing Requirements and Commitments: Reports

The Food and Drug Administration Modernization Act of 1997 requires FDA to publish annually a notice in the Federal Register containing information on the performance of postmarket studies and clinical trials that FDA requires, or has requested, of manufacturers. Learn more.

Published: May 30, 2025 | Category: FDA | Name: FDA Drugs

Ongoing | Infectious Disease Accelerated Approvals Vaccines

Biologic Accelerated Approvals Based on a Surrogate Endpoint

Published: May 30, 2025 | Category: FDA | Name: FDA Biologics

Devices Guidances

This page lists Medical Device Guidance documents.

Published: May 30, 2025 | Category: FDA | Name: FDA Biologics

FDA Responses to Action Items Identified in 2023 Intergovernmental Working Meeting on Drug Compounding

In the most recent Intergovernmental Working Meeting on Drug Compounding, Nov. 7-8, 2023, FDA and state regulators identified three actions items. This page contains a summary of those action items and how FDA has responded.

Published: May 30, 2025 | Category: FDA | Name: FDA Drugs

Inter-governmental Working Meeting on Drug Compounding | November 7-8, 2023

Published: May 30, 2025 | Category: FDA | Name: FDA Drugs

M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver

This draft guidance describes the scientific and technical aspects of study design and data analysis to support bioequivalence assessment for additional strengths of orally administered immediate-release solid oral dosage forms.

Published: May 30, 2025 | Category: FDA | Name: FDA Drugs

Medgel Private Limited - 654085 - 05/22/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: May 29, 2025 | Category: FDA | Name: FDA Drugs

Medgel Private Limited - 654085 - 07/20/2023

CGMP/Finished Pharmaceuticals/Adulterated

Published: May 29, 2025 | Category: FDA | Name: FDA Drugs

Newly Added Guidance Documents

Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.

Published: May 29, 2025 | Category: FDA | Name: FDA Drugs

Replacing Color Additives in Approved or Marketed Drug Products

This draft guidance provides recommendations for replacing color additives in approved or marketed drug products.

Published: May 29, 2025 | Category: FDA | Name: FDA Drugs

FDA Grand Rounds – Anti-biofilm Technologies for Enhancing the Safety of Medical Device Surfaces - 05/29/2025

Anti-biofilm Technologies for Enhancing the Safety of Medical Device Surfaces, May 29, 2025.

Published: May 28, 2025 | Category: FDA | Name: FDA Drugs

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

This guidance describes the mechanisms available through which submitters can request FDA feedback regarding potential or planned medical device submissions.

Published: May 28, 2025 | Category: FDA | Name: FDA Biologics

Electronic Submission Template for Medical Device Q-Submissions

This guidance provides the standards for the submission of certain Q-Subs by electronic format and a timetable for establishment of these standards.

Published: May 28, 2025 | Category: FDA | Name: FDA Biologics

List of Active RDRC Sites

Published: May 27, 2025 | Category: FDA | Name: FDA Drugs

Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA) - 07/11/2025

FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments for fiscal years 2028 through 2032.

Published: May 27, 2025 | Category: FDA | Name: FDA Drugs

Cetirizine or Levocetirizine: Drug Safety Communication - FDA Warns About Risk of Severe Itching After Discontinuation of Long-Term Use of Allergy Medicines

The FDA is warning that patients stopping the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) after long-term use may experience rare but severe itching. These medicines are available in prescription and over-the-counter (OTC) forms. The itching, also called pruritus, has been r

Published: May 27, 2025 | Category: FDA | Name: FDA Drugs

AACE Pharmaceuticals, Inc. - 701310 - 05/13/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: May 27, 2025 | Category: FDA | Name: FDA Drugs

Shenzhen Hengkaifeng Commerce and Trade Co., Ltd - 706318 - 05/06/2025

Failure to List/Misbranded

Published: May 27, 2025 | Category: FDA | Name: FDA Drugs

About the Quantitative Medicine Center of Excellence (QM CoE)

To ensure the CoE is equipped to carry out its mission, the CoE will be governed by leadership from the Office of Generic Drugs, Office of New Drugs, Office of Pharmaceutical Quality, and Office of Translational Sciences.

Published: May 27, 2025 | Category: FDA | Name: FDA Drugs

PDUFA VIII: Fiscal Years 2028 – 2032

Information related to FDA’s preparation for the seventh reauthorization of PDUFA.

Published: May 23, 2025 | Category: FDA | Name: FDA Drugs

Public Meeting on the Reauthorization of the Prescription Drug User Fee Act (PDUFA) - 07/14/2025

The public meeting will be held on July 14, 2025, from 9 a.m. to 2 p.m. The meeting agenda, public docket information, additional materials, and any other updates will also be posted to this website as they become available.   

Published: May 23, 2025 | Category: FDA | Name: FDA Drugs

UPDATED PUBLIC PARTICIPATION INFORMATION: January 10, 2025: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement - 01/10/2025

January 10, 2025: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement

Published: May 23, 2025 | Category: FDA | Name: FDA Drugs

YF-VAX

For active immunization for the prevention of yellow fever in persons 9 months of age and older for persons living in or travelling to endemic areas, persons travelling internationally through countries with yellow fever, and laboratory personnel who handle virulent yellow fever virus.

Published: May 23, 2025 | Category: FDA | Name: FDA Biologics

Meeting Materials, Vaccines and Related Biological Products Advisory Committee

These are the Meeting Materials for the Vaccines and Related Biological Products Advisory Committee

Published: May 23, 2025 | Category: FDA | Name: FDA Biologics

Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee

These are the Meeting Materials for the Cellular, Tissue and Gene Therapies Advisory Committee

Published: May 23, 2025 | Category: FDA | Name: FDA Biologics

Meeting Materials, Blood Products Advisory Committee

This is the Meeting Materials, Blood Products Advisory Committee main landing page

Published: May 23, 2025 | Category: FDA | Name: FDA Biologics

Coronavirus (COVID-19) | CBER-Regulated Biologics

This page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance.

Published: May 22, 2025 | Category: FDA | Name: FDA Biologics

COVID-19 Vaccines (2025-2026 Formula) for Use in the United States Beginning in Fall 2025

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on May 22, 2025, to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the United States beginning in the fall of 2025.

Published: May 22, 2025 | Category: FDA | Name: FDA Biologics

Flublok Quadrivalent

Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older.

Published: May 22, 2025 | Category: FDA | Name: FDA Biologics

UMARY- USA.COM Issues Voluntary Nationwide Recall of UNAVY ÁCIDO HIALURÓNICO Caplets and UMOVY ÁCIDO HIALURÓNICO Caplets Due to the Presence of Undeclared Drug Ingredients Dexamethasone, Diclofenac and Omeprazole

FOR IMMEDIATE RELEASE – Date: May 21 2025, Nogales, AZ, UMARY USA is voluntarily recalling all lots of Unavy Ácido HIALURÓNICO (30 caplets/850 mg) and Umovy Ácido HIALURÓNICO (30 caplets/850 mg), to the consumer level. FDA laboratory analysis confirmed that these products are tainted with the drug i

Published: May 22, 2025 | Category: FDA | Name: FDA Drugs

FDA Takes Action to Address Data Integrity Concerns with Two Chinese Third-Party Testing Firms

The U.S. Food and Drug Administration’s Center for Devices and Radiological Health has issued letters to two third-party medical device testing firms in China.

Published: May 22, 2025 | Category: FDA | Name: FDA Press Release

FDA and CBP Seize Nearly $34 Million Worth of Illegal E-Cigarettes During Joint Operation

The U.S. Food and Drug Administration (FDA) today announced the seizure of nearly two million units of unauthorized e-cigarette products in Chicago, with an estimated retail value of $33.8 million.

Published: May 22, 2025 | Category: FDA | Name: FDA Press Release

Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC - 654751 - 05/19/2025

Electronic Drug Registration and Listing System (eDRLS)/Violations

Published: May 22, 2025 | Category: FDA | Name: FDA Drugs

Generic Drug Research Priorities & Projects

In accordance with the Generic Drug User Fee Amendments (GDUFA), FDA consults with industry and the public to create an annual list of regulatory science initiatives on generic drugs. These priorities are discussed and developed in public meetings and workshops, resulting in several awarded projects

Published: May 21, 2025 | Category: FDA | Name: FDA Drugs

Written Requests Issued

Updated list of approved active moieties to which FDA has issued a Written Request for pediatric studies

Published: May 21, 2025 | Category: FDA | Name: FDA Drugs

FDA takes steps to enhance state importation programs to help lower prescription drug prices

The U.S. Food and Drug Administration is continuing to take steps to help state importation programs provide safe, effective and more affordable drugs for American patients, as part of its efforts to implement Executive Order Lowering Drug Prices by Once Again Putting Americans First.

Published: May 21, 2025 | Category: FDA | Name: FDA Press Release

Risk Evaluation and Mitigation Strategies | REMS

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

Published: May 20, 2025 | Category: FDA | Name: FDA Drugs

Upcoming Product-Specific Guidances for Generic Drug Product Development

This web page provides information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective complex generic drug products.

Published: May 20, 2025 | Category: FDA | Name: FDA Drugs

Combination Products Performance Reports

Annual report to Congress on the activities and impact of the Office of Combination Products (OCP)

Published: May 20, 2025 | Category: FDA | Name: FDA Drugs

Skye Biologics Holdings LLC - 654466 - 12/16/2024

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: May 20, 2025 | Category: FDA | Name: FDA Biologics

Sarfez Pharmaceuticals, Inc. - 708901 - 04/25/2025

False & Misleading Claims/Misbranded

Published: May 20, 2025 | Category: FDA | Name: FDA Drugs

United Health Products, Inc. - 697777 - 03/24/2025

Bioresearch Monitoring Program/Institutional Review Board (IRB)

Published: May 20, 2025 | Category: FDA | Name: FDA Biologics

Wuxi Medical Instrument Factory Co., Ltd. - 701044 - 04/04/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: May 20, 2025 | Category: FDA | Name: FDA Drugs

Product Society LLC - 702927 - 05/08/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: May 20, 2025 | Category: FDA | Name: FDA Drugs

Supreme Rejuvenation, LLC - 700749 - 05/05/2025

Unapproved New Drugs/Misbranded

Published: May 20, 2025 | Category: FDA | Name: FDA Biologics

NWL Netherlands Services B.V. - 701206 - 04/01/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: May 20, 2025 | Category: FDA | Name: FDA Drugs

FishMoxFishFlex/Simple Pet Health LLC - 707196 - 05/08/2025

Unapproved New Animal Drug/Misbranded

Published: May 20, 2025 | Category: FDA | Name: FDA Drugs

NUVAXOVID

Indication: NUVAXOVID is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older.

Published: May 17, 2025 | Category: FDA | Name: FDA Biologics

Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program

Published: May 16, 2025 | Category: FDA | Name: FDA Drugs

Drug Development Tool (DDT) Qualification Programs

Information about the mission and objectives of FDA’s Drug Development Tool (DDT) qualification programs.

Published: May 16, 2025 | Category: FDA | Name: FDA Drugs

Biomarker Qualification Program

The Drug Development Tools (DDT) Research Grant Cycle for Fiscal Years (FY) 2024 is now open.

Published: May 16, 2025 | Category: FDA | Name: FDA Drugs

FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names)

Published: May 16, 2025 | Category: FDA | Name: FDA Drugs

FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease

The U.S. Food and Drug Administration cleared the first blood test, which measures two key biomarkers, to aid in diagnosing Alzheimer’s disease in people exhibiting symptoms of the disease.

Published: May 16, 2025 | Category: FDA | Name: FDA Press Release

FDA to Host Inaugural, Independent, Scientific Expert Panel Open to Public

FDA’s Commissioner Martin A. Makary, M.D., M.P.H., will lead the inaugural meeting of an independent panel of scientific experts to discuss talc exposure in a public forum on Tuesday, May 20, 2025 at 10 a.m. ET.

Published: May 16, 2025 | Category: FDA | Name: FDA Press Release

NCTR Annual Reports

NCTR Annual Reports (Research Accomplishments and Plans) summarize the key accomplishments for each Research Division for the calendar year as well as the plans for the upcoming year.

Published: May 16, 2025 | Category: FDA | Name: FDA Drugs

FDA Advances Robust, Transparent Post-Market Chemical Review Program to Keep Food Supply Safe and Healthy

The U.S. Food and Drug Administration today is taking a major step to increase transparency and ensure the safety of chemicals in our food

Published: May 15, 2025 | Category: FDA | Name: FDA Press Release

Umary and Related Products

Information regarding Umary, a product marketed as a dietary supplement

Published: May 15, 2025 | Category: FDA | Name: FDA Drugs

Human Drug Compounding

Compounded drugs can serve an important medical need for certain patients, they also present a risk to patients.

Published: May 15, 2025 | Category: FDA | Name: FDA Drugs

FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal

Published: May 15, 2025 | Category: FDA | Name: FDA Drugs

Online Controlled Substances Summits

FDA hosted its fourth summit on June 8, 2023, as an integral part of FDA’s overall efforts to protect the public, including youth, from harm associated with drugs that have abuse potential.

Published: May 15, 2025 | Category: FDA | Name: FDA Drugs

Nana Barseghian, M.D. - 708009 - 04/28/2025

Clinical Investigator

Published: May 15, 2025 | Category: FDA | Name: FDA Drugs

Umovy may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Umovy, a product promoted and sold for joint pain on various websites, including www.umovy-usa.com, and possibly in some retail stores.

Published: May 15, 2025 | Category: FDA | Name: FDA Drugs

Unavy may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Unavy, a product promoted and sold for joint pain on various websites, including www.umary-usa.com, and possibly in some retail stores.

Published: May 15, 2025 | Category: FDA | Name: FDA Drugs

Amoxicillin Clavulanate – Oral products

Amoxicillin Clavulanate – Oral Products

Published: May 15, 2025 | Category: FDA | Name: FDA Drugs

FDA Rationale for Recognition Decision: Amoxicillin and Clavulanate against Haemophilus influenzae

Published: May 15, 2025 | Category: FDA | Name: FDA Drugs

dolotrex may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use dolotrex, a product promoted and sold for joint pain on various websites, including, www.innovacionnatural.com, and possibly in some retail stores.

Published: May 15, 2025 | Category: FDA | Name: FDA Drugs

Fluzone and Fluzone High-Dose

Product approval information for Influenza Virus Vaccine

Published: May 14, 2025 | Category: FDA | Name: FDA Biologics

FDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression

On May 14, 2025, the Food and Drug Administration granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC)

Published: May 14, 2025 | Category: FDA | Name: FDA Drugs

GARDASIL

Product approval information for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant also known as Gardasil.

Published: May 14, 2025 | Category: FDA | Name: FDA Biologics

FDA approves belzutifan for pheochromocytoma or paraganglioma

On May 14, 2025, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL).

Published: May 14, 2025 | Category: FDA | Name: FDA Drugs

JYNNEOS

Indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.

Published: May 14, 2025 | Category: FDA | Name: FDA Biologics

Clinical Investigator Status (Biologics)

Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER

Published: May 13, 2025 | Category: FDA | Name: FDA Biologics

Clinical Investigator Inspection List E-K

Contains names, addresses, and other information gathered from inspections of clinical investigators (E-K) who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

Published: May 13, 2025 | Category: FDA | Name: FDA Biologics

Clinical Investigator Inspection List L-P

Contains names, addresses, and other information gathered from inspections of clinical investigators (L-P) who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

Published: May 13, 2025 | Category: FDA | Name: FDA Biologics

Clinical Investigator Inspection List Q-S

Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER

Published: May 13, 2025 | Category: FDA | Name: FDA Biologics

Clinical Investigator Inspection List A-D

Contains names, addresses, and other information gathered from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

Published: May 13, 2025 | Category: FDA | Name: FDA Biologics

Clinical Investigator Inspection List T-Z

Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER

Published: May 13, 2025 | Category: FDA | Name: FDA Biologics

FDA 101: Product Recalls

Recalls are typically voluntary actions taken by a company to remove or correct products on the market that violate U.S. Food and Drug Administration laws and regulations. Recalls may be initiated proactively by a company, at FDA request, or ordered under statutory authority.

Published: May 13, 2025 | Category: FDA | Name: FDA Drugs

FDA Begins Action To Remove Ingestible Fluoride Prescription Drug Products for Children from the Market

FDA begins action to remove unapproved fluoride drug products from the market for the well-being of children

Published: May 13, 2025 | Category: FDA | Name: FDA Press Release

About CBER

The Center for Biologics Evaluation and Research (CBER) is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services

Published: May 13, 2025 | Category: FDA | Name: FDA Biologics

HHS, FDA Initiate Comprehensive Review of Nutrients in Infant Formula

Today, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced the next steps in Operation Stork Speed

Published: May 13, 2025 | Category: FDA | Name: FDA Press Release

HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers

Published: May 13, 2025 | Category: FDA | Name: FDA Press Release

Taizhou Jingshang Cosmetics Technology Co., Ltd. - 701945 - 04/02/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: May 13, 2025 | Category: FDA | Name: FDA Drugs

Excelvision Fareva - 703245 - 05/07/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: May 13, 2025 | Category: FDA | Name: FDA Drugs

BioAsia Worldwide Sdn Bhd - 700093 - 03/25/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: May 13, 2025 | Category: FDA | Name: FDA Drugs

Mentha & Allied Products Private Ltd. - 700242 - 04/16/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: May 13, 2025 | Category: FDA | Name: FDA Drugs

Shantou S.E.Z. Baojie Industry Co., Ltd. - 703439 - 04/15/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: May 13, 2025 | Category: FDA | Name: FDA Drugs

Ningbo Riway Industrial Co., Ltd. - 692870 - 04/30/2025

CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

Published: May 13, 2025 | Category: FDA | Name: FDA Drugs

OSRX, Inc. - 701889 - 04/23/2025

Compounding Pharmacy/Adulterated Drug Products

Published: May 13, 2025 | Category: FDA | Name: FDA Drugs

Tailstorm Health Inc. dba Medivant Health - 703497 - 04/08/2025

Compounding Pharmacy/Adulterated Drug Products

Published: May 13, 2025 | Category: FDA | Name: FDA Drugs

IXCHIQ

For the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at high risk of exposure to CHIKV.

Published: May 12, 2025 | Category: FDA | Name: FDA Biologics

Allergenics

Lists three types of allergenic products licensed for use: allergen extracts, allergen patch tests, and antigen skin tests. Allergen extracts are used for the diagnosis and/or treatment of allergic diseases such as allergic rhinitis ("hay fever"), allergic sinusitis, allergic conjunctivitis, bee ven

Published: May 12, 2025 | Category: FDA | Name: FDA Biologics

Development & Approval Process (CBER)

Key resources and information related to CBER development & approval process.

Published: May 12, 2025 | Category: FDA | Name: FDA Biologics

FDA and CDC Recommend Pause in Use of Ixchiq (Chikungunya Vaccine, Live) in Individuals 60 Years of Age and Older While Postmarketing Safety Reports are Investigated: FDA Safety Communication

The FDA and the CDC are recommending a pause in the use of Ixchiq (Chikungunya Vaccine, Live) in individuals 60 years of age and older while the Agencies investigate postmarketing reports of serious adverse events, including neurologic and cardiac events, in individuals who have received the vaccine

Published: May 12, 2025 | Category: FDA | Name: FDA Biologics

FDA and CDC Recommend Pause in Use of Ixchiq (Chikungunya Vaccine, Live) in Individuals 60 Years of Age and Older While Postmarketing Safety Reports are Investigated

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are recommending a pause in the use of Ixchiq (Chikungunya Vaccine, Live) in individuals 60 years of age and older while the Agencies investigate postmarketing reports of serious adverse events, including

Published: May 10, 2025 | Category: FDA | Name: FDA Biologics

FDA and NIH Announce Innovative Joint Nutrition Regulatory Science Program

Published: May 9, 2025 | Category: FDA | Name: FDA Press Release

Tianeptine Products Linked to Serious Harm, Overdoses, Death

Tianeptine is not approved by the FDA for any medical use. Some companies are illegally marketing and selling tianeptine products and making dangerous and unproven claims that tianeptine can improve brain function and treat anxiety, depression, pain, opioid use disorder, and other conditions.

Published: May 9, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves Three Food Colors from Natural Sources

The U.S. Food and Drug Administration today announced it granted three new color additive petitions that will expand the palette of available colors from natural sources for manufacturers to safely use in food.

Published: May 9, 2025 | Category: FDA | Name: FDA Press Release

May 20-21, 2025: Meeting of the Oncologic Drugs Advisory Committee - 05/20/2025

May 20-21, 2025: Meeting of the Oncologic Drugs Advisory Committee

Published: May 9, 2025 | Category: FDA | Name: FDA Drugs

Meeting of the Oncologic Drugs Advisory Committee - 05/20/2025

Meeting of the Oncologic Drugs Advisory Committee

Published: May 8, 2025 | Category: FDA | Name: FDA Drugs

Fiscal Year 2025 Generic Drug Science and Research Initiatives Public Workshop - 06/03/2025

Fiscal Year 2025 Generic Drug Science and Research Initiatives Public Workshop

Published: May 8, 2025 | Category: FDA | Name: FDA Drugs

Tianeptine

FDA alerts and notices regarding tianeptine

Published: May 8, 2025 | Category: FDA | Name: FDA Drugs

Counterfeit Medicine

Counterfeit (fake or falsified) medicines may be harmful to your health because while being passed off as authentic, may contain the wrong ingredients, contain too much, too little or no active ingredient at all or contain other harmful ingredients.

Published: May 8, 2025 | Category: FDA | Name: FDA Drugs

FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer

On May 8, 2025, the Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack, Verastem, Inc.) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.

Published: May 8, 2025 | Category: FDA | Name: FDA Drugs

FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline

FDA announced an aggressive timeline to scale AI across all centers by June 30.

Published: May 8, 2025 | Category: FDA | Name: FDA Press Release

FDA CDER Overview: Certificates of Confidentiality - 05/07/2025

FDA CDER Overview: Certificates of Confidentiality

Published: May 7, 2025 | Category: FDA | Name: FDA Drugs

Skin Beauty Solutions - 683006 - 07/25/2024

Finished Pharmaceuticals/Unapproved New Drugs

Published: May 7, 2025 | Category: FDA | Name: FDA Drugs

Barkey GmbH & Co. KG - 657073 - 07/30/2024

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

Published: May 7, 2025 | Category: FDA | Name: FDA Biologics

Matte Beauty - 679463 - 07/25/2024

Finished Pharmaceuticals/Unapproved New Drugs

Published: May 7, 2025 | Category: FDA | Name: FDA Drugs

Repare Skincare - 680247 - 07/25/2024

Finished Pharmaceuticals/Unapproved New Drugs

Published: May 7, 2025 | Category: FDA | Name: FDA Drugs

ISIS.GOLD - 679948 - 07/25/2024

Finished Pharmaceuticals/Unapproved New Drugs

Published: May 7, 2025 | Category: FDA | Name: FDA Drugs

Walmart, Inc. - 683095 - 07/25/2024

Finished Pharmaceuticals/Unapproved New Drugs

Published: May 7, 2025 | Category: FDA | Name: FDA Drugs

Amazon.com, Inc. - 679523 - 07/25/2024

Finished Pharmaceuticals/Unapproved New Drugs

Published: May 7, 2025 | Category: FDA | Name: FDA Drugs

CDER Emerging Drug Safety Technology Program (EDSTP)

The EDSTP is specifically focused on the use of artificial intelligence and other emerging technologies in pharmacovigilance and is part of the Center for Drug Evaluation and Research. Learn more.

Published: May 7, 2025 | Category: FDA | Name: FDA Drugs

Emerging Drug Safety Technology Meetings (EDSTM)

CDER has established a meeting program called the Emerging Drug Safety Technology Meeting (EDSTM) program. Learn more.

Published: May 7, 2025 | Category: FDA | Name: FDA Drugs

Vaccines and Related Biological Products Advisory Committee May 22, 2025 Meeting Announcement - 05/22/2025

On May 22, 2025, the committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the 2025-2026 Formula for COVID-19 vaccines.

Published: May 7, 2025 | Category: FDA | Name: FDA Biologics

FDA Compounding Documents and Actions

Find descriptions of some of the documents and actions, such as warning letters, recalls, Form 483 and inspection warrant, involved in DA oversight of compounding facilities.

Published: May 7, 2025 | Category: FDA | Name: FDA Drugs

EnShiShiXiangNiShangMaoYouXianGongSi Issues Voluntary Nationwide Recall of ENDURANCE BOOST WITH HORNY GOAT WEED Capsules Due To Presence of Undeclared Propoxyphenylsildenafil and Sildenafil

EnShiShiXiangNiShangMaoYouXianGongSi is voluntarily recalling one lot of ENDURANCE BOOST WITH HORNY GOAT WEED (20 Count)

Published: May 6, 2025 | Category: FDA | Name: FDA Drugs

FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

The U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients.

Published: May 6, 2025 | Category: FDA | Name: FDA Press Release

Nana Barseghian, M.D./Amicis Research Center - 708009 - 04/28/2025

Clinical Investigator

Published: May 6, 2025 | Category: FDA | Name: FDA Drugs

CDER Small Business and Industry Assistance (SBIA) Learn

SBIA Learn offers a variety of multimedia resources to provide information that is comprehensive, interactive, and easily accessible to small pharmaceutical business and industry.

Published: May 5, 2025 | Category: FDA | Name: FDA Drugs

CDER Bioresearch Monitoring: Electronic Submission Requirements for New Drug and Biologic Licensing Applications - 05/06/2025

CDER Bioresearch Monitoring: Electronic Submission Requirements for New Drug and Biologic Licensing Applications

Published: May 5, 2025 | Category: FDA | Name: FDA Drugs

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration - 05/20/2025

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration

Published: May 5, 2025 | Category: FDA | Name: FDA Drugs

Primary Mitochondrial Diseases Virtual Public Workshop - 05/22/2025

Primary Mitochondrial Diseases Virtual Public Workshop

Published: May 5, 2025 | Category: FDA | Name: FDA Drugs

CDER Quality Management Maturity

FDA has proposed the development of a rating system that will help incentivize drug manufacturers to achieve Quality Mangement Maturity at their facilities.

Published: May 5, 2025 | Category: FDA | Name: FDA Drugs

Bioresearch Monitoring Information System (BMIS)

Bioresearch Monitoring Information System (BMIS) background page with download file.

Published: May 5, 2025 | Category: FDA | Name: FDA Drugs

Patient Listening Session Summaries

Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement Staff draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions.

Published: May 2, 2025 | Category: FDA | Name: FDA Drugs

Requesting an FDA Patient-Led Listening Session

Learn about how to request a Patient Listening Session with the FDA to share your experiences and perspectives.

Published: May 2, 2025 | Category: FDA | Name: FDA Drugs

Suggested Sample Agenda for an FDA Patient-Led Listening Session

View a suggested sample agenda an FDA Patient-Led Listening Session

Published: May 2, 2025 | Category: FDA | Name: FDA Drugs

Planning an FDA Patient-Led Listening Session

Learn the steps for planning an FDA Patient-Led Listening Session.

Published: May 2, 2025 | Category: FDA | Name: FDA Drugs

Preparing Patient and Caregiver Participants for an FDA Patient-Led Listening Session and Suggested Topics

Learn about topics that are outside of the scope of FDA’s work and suggested topics for FDA-Patient-Led Listening Sessions.

Published: May 2, 2025 | Category: FDA | Name: FDA Drugs

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

Published: May 2, 2025 | Category: FDA | Name: FDA Drugs

Standard Safety Tables and Figures (ST&Fs)

The Standard Safety Tables and Figures (ST&Fs) are designed to reduce clinical reviewers’ time in generating safety review content and to ensure consistency in the safety review of products across Divisions.

Published: May 1, 2025 | Category: FDA | Name: FDA Drugs

Office of New Drugs Custom Medical Queries (OCMQs)

Office of New Drugs Custom Medical Queries (OCMQs) are standardized groupings of similar adverse event terms intended to assist with the identification of potential safety issues during review of adverse event data.

Published: May 1, 2025 | Category: FDA | Name: FDA Drugs

Generic Drug Research-Related Guidances & Reports

The research studies conducted under Generic Drug User Fee Amendments (GDUFA) initiatives support development of general and product-specific guidances for industry to efficiently develop new generic products. OGD also publishes an annual research report each fiscal year, summarizing the research ac

Published: May 1, 2025 | Category: FDA | Name: FDA Drugs

FY 2024 GDUFA Science and Research Report

The FY 2024 GDUFA Science and Research report describes active research projects and outcomes organized into eight chapters corresponding to the eight established priority areas with a ninth chapter reporting on additional generic drug science and research.

Published: May 1, 2025 | Category: FDA | Name: FDA Drugs

V10Suppliers.com - 685496 - 07/22/2024

Finished Pharmaceuticals/Unapproved New Drug/Misbranded

Published: Apr 30, 2025 | Category: FDA | Name: FDA Drugs

Genuine Virgin Aloe Corp dba Triderma - 679744 - 07/01/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Apr 30, 2025 | Category: FDA | Name: FDA Drugs

Yahon Enterprise Co., Ltd. - 675592 - 06/05/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Apr 30, 2025 | Category: FDA | Name: FDA Drugs

Brassica Pharma Pvt. Ltd. - 679005 - 07/11/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Apr 30, 2025 | Category: FDA | Name: FDA Drugs

Advisory Letters

Published: Apr 30, 2025 | Category: FDA | Name: FDA Drugs

Empower Clinic Services, LLC dba Empower Pharmacy - 700964 - 04/02/2025

Compounding Pharmacy/Adulterated Drug Products

Published: Apr 29, 2025 | Category: FDA | Name: FDA Drugs

Bailey’s Wellness, LLC dba Bailey’s CBD - 701066 - 04/07/2025

Unapproved New Animal Drug Products

Published: Apr 29, 2025 | Category: FDA | Name: FDA Drugs

BEO Pharma Inc. dba BEO Pharmaceuticals Inc. - 701364 - 04/09/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Apr 29, 2025 | Category: FDA | Name: FDA Drugs

Dyno Manufacturing, Inc. - 700785 - 04/09/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Apr 29, 2025 | Category: FDA | Name: FDA Drugs

Cosco International, Inc. - 701209 - 04/14/2025

CGMP/Finished Pharmaceuticals/Adulterated/Misbranded

Published: Apr 29, 2025 | Category: FDA | Name: FDA Drugs

Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC - 654751 - 03/28/2025

Electronic Drug Registration and Listing System (eDRLS)/Violations

Published: Apr 29, 2025 | Category: FDA | Name: FDA Drugs

Amazon.com, Inc. - 689355 - 04/17/2025

Unapproved New Drugs/Misbranded

Published: Apr 29, 2025 | Category: FDA | Name: FDA Drugs

Types of Drug Master Files (DMFs)

The types of DMFs are Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product, Type III Packaging Material, Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation, Type V FDA-Accepted Reference Information.

Published: Apr 28, 2025 | Category: FDA | Name: FDA Drugs

Artrifan King may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Artrifan King, a product promoted and sold for joint pain on various websites, including www.artriking.us, and possibly in some retail stores.

Published: Apr 25, 2025 | Category: FDA | Name: FDA Drugs

Anesthetic and Analgesic Drug Products Advisory Committee Roster

This page contains the AADPAC roster, which lists the current members and the current number of vacancies for the committee.

Published: Apr 24, 2025 | Category: FDA | Name: FDA Drugs

Drug Safety and Risk Management Advisory Committee Roster

This page contains the DSARM roster, which lists the current members and the current number of vacancies for the committee.

Published: Apr 24, 2025 | Category: FDA | Name: FDA Drugs

FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma

On April 23, 2025, the Food and Drug Administration approved penpulimab-kcqx (Akeso Biopharma Co., Ltd.) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC).

Published: Apr 24, 2025 | Category: FDA | Name: FDA Drugs

Pain and Arthritis Products Containing Hidden Ingredients

Learn about the warnings for pain and arthritis products that contain hidden drugs and other hidden ingredients.

Published: Apr 23, 2025 | Category: FDA | Name: FDA Drugs

Painflex Forte may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Painflex Forte, a product promoted and sold for joint pain on various websites, including ibspot.com and possibly in some retail stores.

Published: Apr 23, 2025 | Category: FDA | Name: FDA Drugs

Max Chemical Inc. - 682037 - 06/20/2024

CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

Published: Apr 23, 2025 | Category: FDA | Name: FDA Drugs

Cholrem Pty Ltd dba Cholrem and Cholrem Pharmaceuticals - 684036 - 07/09/2024

Finished Pharmaceuticals/Unapproved New Drugs

Published: Apr 23, 2025 | Category: FDA | Name: FDA Drugs

YangZhou SuXiang Medical Instrument Co., Ltd. - 686655 - 07/08/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Apr 23, 2025 | Category: FDA | Name: FDA Drugs

New Mexico Lions Sight Conservation Foundation, Inc. dba New Mexico Lions Eye Bank - 681776 - 06/20/2024

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Apr 23, 2025 | Category: FDA | Name: FDA Biologics

Optikem International Inc. - 680264 - 06/20/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Apr 23, 2025 | Category: FDA | Name: FDA Drugs

Laboratorio Magnachem International - 673796 - 06/18/2024

CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

Published: Apr 23, 2025 | Category: FDA | Name: FDA Drugs

reBom Co., Ltd. - 682811 - 06/26/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Apr 23, 2025 | Category: FDA | Name: FDA Drugs

HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply

The U.S. Department of Health and Human Services and FDA today announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply—a significant milestone in the administration’s broader initiative to Make America Healthy Again.

Published: Apr 22, 2025 | Category: FDA | Name: FDA Press Release

FDA alerts health care providers, compounders and consumers of potential risks associated with compounded topical finasteride products

FDA has become aware of reports of adverse events involving compounded topical finasteride products potentially putting consumers at risk.

Published: Apr 22, 2025 | Category: FDA | Name: FDA Drugs

Compounding Risk Alerts

FDA issues compounding risk alerts to communicate information to alert health care professionals to adverse events and outbreaks related to compounded drugs so that practitioners can more effectively protect patients from unsafe, ineffective, and poor quality compounded medicines.

Published: Apr 22, 2025 | Category: FDA | Name: FDA Drugs

Empower Clinic Services, LLC dba Empower Pharma - 700962 - 04/02/2025

Compounding Pharmacy/Adulterated Drug Products

Published: Apr 22, 2025 | Category: FDA | Name: FDA Drugs

Generic Drug User Fee Amendments

FDA is soliciting general comments on GDUFA II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA Program Fees in a timely manner.

Published: Apr 21, 2025 | Category: FDA | Name: FDA Drugs

Amneal Pharmaceutical LLC Issues a Nationwide Recall of Ropivacaine Hydrochloride Injection, USP 500mg/100mL, Due to the Potential Presence of Particulate Matter

Bridgewater, NJ, Amneal Pharmaceutical LLC, is recalling two lots of Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, Infusion bags to the hospital/user level as the products may contain an inert fiber identified as polypropylene fibers from the IV bag.

Published: Apr 18, 2025 | Category: FDA | Name: FDA Drugs

FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees

FDA Commissioner Martin A. Makary, M.D., M.P.H. announces a policy directive that limits individuals employed at companies regulated by the FDA from serving as official members on FDA advisory committees, where statutorily allowed

Published: Apr 17, 2025 | Category: FDA | Name: FDA Press Release

POSTPONED - Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act - 05/15/2025

Section 508 of PL 112-144 (FDASIA) requires FDA to obtain recommendations and relevant information from interested parties on the required report to Congress submitted by the HHS Secretary every 5 years on the implementation of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act (sections 505A and 505B of the FD&C Act).

Published: Apr 16, 2025 | Category: FDA | Name: FDA Drugs

The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Certain Rugby® Laboratories Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections

La Vergne, TN, The Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and Rugby® Laboratories is initiating a voluntarily recall for all lots of Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) supplied by Velocity Pharma, LLC to the co

Published: Apr 16, 2025 | Category: FDA | Name: FDA Drugs

List of Drug Master Files (DMFs)

The list is updated quarterly. Changes are made to the DMF activity status, DMF type, holder name, and subject.

Published: Apr 16, 2025 | Category: FDA | Name: FDA Drugs

Where and How to Dispose of Unused Medicines

The best way to dispose of your expired, unwanted, or unused medicines is through a drug take back program. Or you can do it at home. Check the FDA flush list.

Published: Apr 16, 2025 | Category: FDA | Name: FDA Drugs

FDA Rationale for Breakpoints Recognition Decision: Piperacillin-Tazobactam and Pseudomonas aeruginosa

Published: Apr 16, 2025 | Category: FDA | Name: FDA Drugs

Naturista Store LLC - 701480 - 03/26/2025

Unapproved New Drugs/Misbranded

Published: Apr 15, 2025 | Category: FDA | Name: FDA Drugs

Nubratori, Inc. dba Nubratori Rx - 700513 - 01/22/2025

Compounding Pharmacy/Adulterated Drug Products

Published: Apr 15, 2025 | Category: FDA | Name: FDA Drugs

PMS4PMS, LLC - 700180 - 04/07/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Apr 15, 2025 | Category: FDA | Name: FDA Drugs

Lot Distribution Database (LDD)

Published: Apr 14, 2025 | Category: FDA | Name: FDA Biologics

FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain

Published: Apr 14, 2025 | Category: FDA | Name: FDA Drugs

FDA Honored to Welcome HHS Secretary Robert F. Kennedy, Jr. to FDA Campus

The U.S. Food and Drug Administration today welcomed HHS Secretary Robert F. Kennedy, Jr. to its headquarters in Silver Spring, Maryland, a visit that included remarks to FDA employees, meetings with agency leadership, and a tour of several medical device innovation laboratories on the Campus

Published: Apr 11, 2025 | Category: FDA | Name: FDA Press Release

FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma

On April 11, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.

Published: Apr 11, 2025 | Category: FDA | Name: FDA Drugs

Sunscreen Meetings

Published: Apr 11, 2025 | Category: FDA | Name: FDA Drugs

FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs

Published: Apr 10, 2025 | Category: FDA | Name: FDA Press Release

Other | Cancer Accelerated Approvals

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been granted for supportive care products and changes to dosing or formulation.

Published: Apr 10, 2025 | Category: FDA | Name: FDA Drugs

FDA Listing of Authorized Generics

Published: Apr 9, 2025 | Category: FDA | Name: FDA Drugs

FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer

On April 8, 2025, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for adult and pediatric patients 12 years of age and older with unresectable or metastatic MSI-H or dMMR colorectal cancer.

Published: Apr 8, 2025 | Category: FDA | Name: FDA Drugs

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up

Golden State Medical Supply, Incorporated (GSMS, Inc.) - Camarillo, CA has initiated a voluntary recall of the products listed in the table below because a report was received that a bottle containing Clopidogrel 75mg Tablets produced with lot# GS046745 was mislabeled as Atenolol 25mg Tablets. This

Published: Apr 8, 2025 | Category: FDA | Name: FDA Drugs

Patient-Focused Drug Development

The OCE PFDD program fosters collaboration between FDA centers and external stakeholders involved in patient outcomes research in cancer populations.

Published: Apr 8, 2025 | Category: FDA | Name: FDA Drugs

www.thesafepills.org - 702942 - 03/27/2025

Unapproved New Drugs/Misbranded

Published: Apr 8, 2025 | Category: FDA | Name: FDA Drugs

Ozempen.com - 684435 - 06/24/2024

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Published: Apr 7, 2025 | Category: FDA | Name: FDA Drugs

Sun Pharmaceutical Industries Limited - 677337 - 06/18/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Apr 7, 2025 | Category: FDA | Name: FDA Drugs

Premier Manufacturing Products, LLC - 678912 - 07/02/2024

Finished Pharmaceuticals/Unapproved New Drug

Published: Apr 7, 2025 | Category: FDA | Name: FDA Drugs

Martin A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner

Renowned surgeon-scientist and health policy expert, Martin A. Makary, M.D., M.P.H., took the oath of office to become the 27th Commissioner of Food and Drugs.

Published: Apr 1, 2025 | Category: FDA | Name: FDA Press Release

Antifungal Susceptibility Test Interpretive Criteria

Published: Apr 1, 2025 | Category: FDA | Name: FDA Drugs

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

Published: Apr 1, 2025 | Category: FDA | Name: FDA Drugs

Coral Snake Antivenom

Coral Snake Antivenom product was manufactured by Wyeth Pharmaceuticals, now a wholly owned subsidiary of Pfizer, Inc. FDA has extended the expiration date on this lot of Antivenin (Micrurus fulvius) (Equine Origin), from January 31, 2018, to January 31, 2019. The extension is based upon FDA evalu

Published: Mar 31, 2025 | Category: FDA | Name: FDA Biologics

October - December 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

This report lists potential signals of serious risks/new safety information that were identified using the FAERS database during October - December 2024. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk.

Published: Mar 31, 2025 | Category: FDA | Name: FDA Drugs

Resource Capacity Planning and Modernized Time Reporting

FDA is making optimal use of its financial resources to maximize its ability to efficiently and effectively deliver on its commitments to the public.

Published: Mar 31, 2025 | Category: FDA | Name: FDA Drugs

Vaccine Safety & Availability

Published: Mar 31, 2025 | Category: FDA | Name: FDA Biologics

Blood Safety & Availability

Published: Mar 31, 2025 | Category: FDA | Name: FDA Biologics

Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank - 680039 - 06/10/2024

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 31, 2025 | Category: FDA | Name: FDA Biologics

Sani-Care Salon Products, Inc. - 673747 - 04/24/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 31, 2025 | Category: FDA | Name: FDA Drugs

Transfusion/Donation Fatalities

This page provides details on the Notification Process for Transfusion Related Fatalities and Donation Related Deaths.

Published: Mar 31, 2025 | Category: FDA | Name: FDA Biologics

Questions about Tissues

Information about tissues, questions and answers, donor screening and testing, donor eligibility

Published: Mar 31, 2025 | Category: FDA | Name: FDA Biologics

FDA approves durvalumab for muscle invasive bladder cancer

On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC).

Published: Mar 28, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors

Today, the U.S. Food and Drug Administration approved a novel treatment for hemophilia A or B, with or without factor VIII or IX inhibitors (neutralizing antibodies).

Published: Mar 28, 2025 | Category: FDA | Name: FDA Drugs

FDA Roundup: March 28, 2025

Published: Mar 28, 2025 | Category: FDA | Name: FDA Press Release

Scientific Public Private Partnerships and Consortia

Find out how CDER works with partners and consortia to identify science gaps in drug development

Published: Mar 28, 2025 | Category: FDA | Name: FDA Drugs

FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication

On March 28, 2025, the Food and Drug Administration expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation). Learn more.

Published: Mar 28, 2025 | Category: FDA | Name: FDA Drugs

New Drug Applications (NDAs)

List of new drug applications

Published: Mar 28, 2025 | Category: FDA | Name: FDA Biologics

C3TI Areas of Interest

C3TI's areas of interest span drug development programs, therapeutic areas, and disciplines. Learn more.

Published: Mar 28, 2025 | Category: FDA | Name: FDA Drugs

FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis

The FDA granted marketing authorization of the first diagnostic test for chlamydia, gonorrhea and trichomoniasis that can be purchased without a prescription and performed entirely at home.

Published: Mar 28, 2025 | Category: FDA | Name: FDA Press Release

Questions about Blood

FDA is responsible for ensuring the safety of the Nation's blood supply. While a blood supply with zero risk of transmitting infectious disease may not be possible, there are several measures taken by FDA to protect and enhance the safety of blood products.

Published: Mar 28, 2025 | Category: FDA | Name: FDA Biologics

Notifications on Data Integrity

FDA notifications for industry on data integrity.

Published: Mar 28, 2025 | Category: FDA | Name: FDA Drugs

FDA to pharmaceutical companies: Certain studies conducted by Raptim Research Pvt. Ltd. are unacceptable

FDA has identified significant data integrity and study conduct concerns with bioequivalence and bioavailability studies conducted by Raptim Research Pvt. Ltd., a contract research organization (CRO) based in Navi Mumbai, India.

Published: Mar 28, 2025 | Category: FDA | Name: FDA Drugs

CDER Center for Clinical Trial Innovation (C3TI)

Enable and amplify existing and future CDER clinical trial innovation through enhanced communication and collaboration

Published: Mar 27, 2025 | Category: FDA | Name: FDA Drugs

Study Data Technical Conformance Guide - Technical Specifications Document

This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic.

Published: Mar 27, 2025 | Category: FDA | Name: FDA Drugs

UPDATED MEETING DATE AND PUBLIC PARTICIPATION INFORMATION: May 5, 2025 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement - 05/05/2025

May 5, 2025: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement

Published: Mar 27, 2025 | Category: FDA | Name: FDA Drugs

Seraclone Blood Grouping Reagents and Anti-Human Globulin Reagents (STN# 125213, 125215, 125217, 125219 - 125233, 125242)

Product approval information is indicated for the determination of the blood group antigens on red blood cells and detecting in vivo and /or in vitro coating of red blood cells using the tube test.

Published: Mar 27, 2025 | Category: FDA | Name: FDA Biologics

Meetings, Conferences, & Workshops | Drugs

Meetings, conferences, and workshops sponsored or co-sponsored by Center for Drug Evaluation and Research.

Published: Mar 27, 2025 | Category: FDA | Name: FDA Drugs

Implementing FDA’s IVPT Guidance Recommendations: A Step-By-Step Illustration - 04/29/2025

The workshop will clarify the intent of FDA recommendations for IVPT studies, with step-by-step demonstrations illustrating how IVPT study procedures can be performed in a manner compatible with recommendations in FDA’s Guidance for Industry&#58; In Vitro Permeation Test Studies for Topical Drug Pro.

Published: Mar 27, 2025 | Category: FDA | Name: FDA Drugs

CDER Data Standards Program

Published: Mar 27, 2025 | Category: FDA | Name: FDA Drugs

Data Standards Program Strategic Plan and Board

The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the efficient and effective review of regulatory submissions. This helps bring safe and effective products to market.

Published: Mar 27, 2025 | Category: FDA | Name: FDA Drugs

Investigational New Drug Applications (INDs) for CBER-Regulated Products

An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.

Published: Mar 27, 2025 | Category: FDA | Name: FDA Biologics

Consumer Updates

Science-based health and safety information you can trust.

Published: Mar 26, 2025 | Category: FDA | Name: FDA Drugs

Expanded Access to Experimental Biologics

Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtai

Published: Mar 26, 2025 | Category: FDA | Name: FDA Biologics

Approved Blood Products

Products that are regulated as Biologics License Applications (BLAs), New Drug Applications (NDAS), Premarket Approvals (PMAs), and 510(k)s.

Published: Mar 26, 2025 | Category: FDA | Name: FDA Biologics

Other Recommendations for Biologics Manufacturers

We have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within Guidances, Rules and other documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.

Published: Mar 26, 2025 | Category: FDA | Name: FDA Biologics

Compliance Actions (Biologics)

CBER carries out a wide range of compliance and surveillance activities during the "life cycle" of biological products

Published: Mar 26, 2025 | Category: FDA | Name: FDA Biologics

Industry (Biologics)

CBER’s Manufacturers Assistance and Technical Training Branch provides assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures.

Published: Mar 26, 2025 | Category: FDA | Name: FDA Biologics

Commemorating the 15th Anniversary of the Biologics Price Competition and Innovation Act

FDA expert discusses the Biologics Price Competition and Innovation Act

Published: Mar 26, 2025 | Category: FDA | Name: FDA Drugs

Pandemics & Emerging Diseases

Published: Mar 26, 2025 | Category: FDA | Name: FDA Biologics

GARDASIL 9

Product approval information for Human Papillomavirus 9-valent Vaccine, Recombinant also known as Gardasil 9.

Published: Mar 26, 2025 | Category: FDA | Name: FDA Biologics

Approvals & Reports

FDA publishes a list of first-time approvals to manufacture generic drugs and a variety of reports on generic drug application reviews.

Published: Mar 26, 2025 | Category: FDA | Name: FDA Drugs

FDA approves cabozantinib for adults and pediatric patients 12 years of age and older with pNET and epNET

On March 26, 2025, the FDA approved cabozantinib (Cabometyx, Exelixis, Inc.) for previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors and well-differentiated extra-pancreatic neuroendocrine tumors.

Published: Mar 26, 2025 | Category: FDA | Name: FDA Drugs

Resources Related to Regenerative Medicine Therapies

Information on FDA’s Framework for the Regulation of Regenerative Medicine Products

Published: Mar 26, 2025 | Category: FDA | Name: FDA Biologics

CBER Biologics Effectiveness and Safety (BEST) System

This is the main page for CBER's Biologics Effectiveness and Safety (BEST) System.

Published: Mar 26, 2025 | Category: FDA | Name: FDA Biologics

Resources for You (Biologics)

Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

Published: Mar 25, 2025 | Category: FDA | Name: FDA Biologics

Consumers (Biologics)

Resources for consumers on biological products.

Published: Mar 25, 2025 | Category: FDA | Name: FDA Biologics

Healthcare Providers (Biologics)

Resources for Healthcare Providers on biological products.

Published: Mar 25, 2025 | Category: FDA | Name: FDA Biologics

NIH Funded Pediatric Labeling Changes for drugs studied under the 409i process

Section 409i of BPCA requires NIH and FDA to prioritize therapeutic areas in critical need of pediatric research. NICHD then facilitates clinical trials and data are submitted to FDA who determines if labeling changes are appropriate. This site lists such approved labeling changes.

Published: Mar 25, 2025 | Category: FDA | Name: FDA Drugs

Outsourcing Facilities Annual Study

Compounding Outsourcing Facilities Annual Study

Published: Mar 25, 2025 | Category: FDA | Name: FDA Drugs

Gepotidacin – Oral Products

Published: Mar 25, 2025 | Category: FDA | Name: FDA Drugs

Center for Biologics Evaluation and Research Patient Engagement Program

Patient input is a critical part of CBER’s understanding of diseases and conditions. Engaging with patients and listening to their perspectives on their diseases and treatments may help the center advance patient-focused medical product development.

Published: Mar 25, 2025 | Category: FDA | Name: FDA Biologics

Americo F. Padilla, M.D. - 700447 - 03/25/2025

Clinical Investigator

Published: Mar 25, 2025 | Category: FDA | Name: FDA Drugs

Update: COVID-19 Vaccine Booster Composition

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) held a virtual meeting on June 28, 2022, to publicly discuss whether a change to the current vaccine strain composition of COVID-19 vaccine booster doses is necessary for the 2022 fall and winter seasons.

Published: Mar 25, 2025 | Category: FDA | Name: FDA Biologics

Data Standards Catalog

Published: Mar 25, 2025 | Category: FDA | Name: FDA Drugs

BPI Labs, LLC - 699533 - 03/20/2025

Unapproved New Drugs/Misbranded

Published: Mar 25, 2025 | Category: FDA | Name: FDA Drugs

Aspen Biopharma Labs Private Limited - 698665 - 03/05/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Mar 25, 2025 | Category: FDA | Name: FDA Drugs

Hangzhou Glamcos Biotech Co., Ltd. - 692583 - 10/07/2024

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

Published: Mar 25, 2025 | Category: FDA | Name: FDA Drugs

Annovex Pharma, Inc. - 698115 - 03/05/2025

Compounding Pharmacy/Adulterated Drug Products

Published: Mar 25, 2025 | Category: FDA | Name: FDA Drugs

Yangzhou Sion Commodity Co., Ltd. - 699183 - 03/12/2025

CGMP/Finished Pharmaceutical/API/Adulterated

Published: Mar 25, 2025 | Category: FDA | Name: FDA Drugs

Food and Drug Omnibus Reform Act (FDORA) of 2022

The Food and Drug Omnibus Reform Act of 2022 (FDORA) requires FDA to develop several different kinds of informational documents, including public reports, reports to Congress, strategic plans, and others.

Published: Mar 25, 2025 | Category: FDA | Name: FDA Drugs

Prescription Drug Marketing Act of 1987

FDA's implementation of the Prescription Drug Marketing Act of 1987

Published: Mar 25, 2025 | Category: FDA | Name: FDA Drugs

Food and Drug Administration Amendments Act (FDAAA) of 2007

Published: Mar 25, 2025 | Category: FDA | Name: FDA Drugs

Neobiosis, LLC - 662985 - 06/05/2024

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 25, 2025 | Category: FDA | Name: FDA Biologics

Fenwal International, Inc. - 603610 - 06/14/2020

CGMP Deviations

Published: Mar 25, 2025 | Category: FDA | Name: FDA Biologics

EUCYT Laboratories LLC - 607182 - 06/04/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 25, 2025 | Category: FDA | Name: FDA Biologics

Montgomery Women's Medical Center PC dba Montgomery Fertility Center - 607345 - 05/14/2020

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 25, 2025 | Category: FDA | Name: FDA Biologics

North Coast Biologics - 607532 - 05/21/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 25, 2025 | Category: FDA | Name: FDA Biologics

American Fertility Medical Center, Genetic Infertility & Andrology Lab - 605068 - 04/02/2020

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 25, 2025 | Category: FDA | Name: FDA Biologics

California IVF Fertility Center - 598552 - 02/26/2020

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 25, 2025 | Category: FDA | Name: FDA Biologics

Banco Vida Corp. - 597197 - 03/04/2020

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 25, 2025 | Category: FDA | Name: FDA Biologics

Reproductive Technologies, Inc. - 594292 - 11/06/2019

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 25, 2025 | Category: FDA | Name: FDA Biologics

R & B Medical Group Inc. - 596508 - 01/15/2020

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 25, 2025 | Category: FDA | Name: FDA Biologics

Noli Oil, LLC - 593497 - 11/22/2019

Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Apothecus Pharmaceutical Corp. - 585666 - 11/08/2019

CGMP/Drug Products/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

A.P. Deauville, LLC - 586306 - 11/08/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Torrent Pharma Inc - 584701 - 10/28/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Greenbrier International, Inc dba Dollar Tree - 574706 - 11/06/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Swabplus, L.P. - 584803 - 10/31/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Farmville Discount Drug, Inc. DBA Best Value Drug - 574044 - 07/09/2019

Compounding Pharmacy/Adulterated Drug Products

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

MSM Nutraceuticals, LLC dba MSM Health Solutions - 584018 - 10/24/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Cadila Healthcare Limited - 584856 - 10/29/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Mylan Laboratories Limited - 589297 - Unit 8

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Dr Jen Hartley/Healing Artistry, LLC - 590265 - 10/29/2019

New Animal Drug/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Strong Fertility Center - 593262 - 10/29/2019

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

Bingbing Pharmaceutical Co., Ltd - 584327 - 10/03/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

PETNET Solutions Inc. - 584016 - 10/17/2019

CGMP/Positron Emission Tomography (PET) Drugs/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Rooted Apothecary LLC - 585312 - 10/10/2019

Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Sofie Co., dba Sofie - 583034 - 10/10/2019

CGMP/Positron Emission Tomography (PET) Drugs/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Jiangsu NHWA Pharmaceutical Co., Ltd. - 582511 - 09/10/2019

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Herbal Doctor Remedies - 583205 - 10/04/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Coral Pharmaceuticals LTD - 586576 - 10/09/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Westlake IVF, LLC - 590113 - 09/30/2019

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

The Skin Atelier, Inc. d.b.a. Skinprint - 582512 - 10/01/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Torrent Pharmaceuticals Limited - 585255 - 10/08/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Family Fertility Center - 588805 - 09/30/2019

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

Stemell Inc - 579013 - 08/28/2019

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

Stratus BioSystems, LLC - 581032 - 07/01/2019

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

Virginia Center for Reproductive Medicine - 583610 - 07/01/2019

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

Abington Memorial Hospital, IRC - 576854 - 06/24/2019

Bioresearch Monitoring Program/IRB

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

University Fertility Laboratory, Inc. - 577584 - 05/30/2019

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

Cord for Life, Inc. - 572770 - 03/29/2019

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

American Preclinical Services - 562382 - 02/12/2019

Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

Genetech, Inc. - 561808 - 11/29/2018

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

University of Miami Reproductive and Fertility Center - 568208 - 12/03/2018

University of Miami Reproductive and Fertility Center, Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

American Botanical Pharmacy - 562180 - 10/30/2018

American Botanical Pharmacy, Unapproved New Drugs/Misbranded

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

StemGenex Biologic Laboratories, LLC - 557907 - 10/31/2018

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

Ignatius P. Godoy, M.D. - 561662 - 10/01/2018

Bioresearch Monitoring Program/IRB

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

Cipher Pharmaceuticals US LLC - 460380 - 08/24/2017

False & Misleading Claims/Misbranded

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

1ViZN LLC - 522724 - 08/23/2017

Unapproved New Drugs/Misbranded

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

American Specialty Pharmacy - 07/28/2017

CGMP/Finished Pharmaceuticals/Adulterated/Misbranded

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Limited Population Pathway for Antibacterial and Antifungal Drugs – the LPAD Pathway

Program landing page

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Ami Cosmetics Co., Ltd. - 07/11/2018

Failure to Comply with Drug Listing Requirements/Misbranded

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

APS BioGroup, Inc - 04/05/2018

Unapproved New Drugs/Misbranded

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Kalchem International, Inc. - 607098 - 03/20/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Baja Fur S.A. de C.V. - 590791 - 12/13/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Dental-Kosmetik GmbH & Co. KG - 591351 - 01/16/2020

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Wave Miami LLC - 590422 - 01/13/2020

Unapproved New Drugs/Misbranded

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

GOJO Industries Inc - 599132 - 01/17/2020

Unapproved New Drugs/Misbranded

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Tismor Health and Wellness Pty Limited - 588104 - 12/05/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

CGA Limited - 589028 - 12/19/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Zhuhai Aofute Medical Technology Co., Ltd. - 590945 - 01/09/2020

CGMP/Finished Pharmaceuticals/Adulterated/Failure to Register/Unapproved or Misbranded

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

James Findling - 598944 - 12/31/2019

Clinical Investigator

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Huaian Zongheng Bio-Tech Co., Ltd - 590789 - 01/09/2020

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Health Pharma USA LLC - 588155 - 12/18/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Grace Analytical Lab Inc - 586510 - 11/19/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

Ningbo BST Clean and Care Products Co., Ltd - 587788 - 11/27/2019

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 24, 2025 | Category: FDA | Name: FDA Drugs

21st Century LaserMed Pain Institute d/b/a Create Wellness Clinics - 607654 - 07/21/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

SHINGRIX

This is the main page for the CBER SHINGRIX.

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

HIZENTRA

Product approval information is indicated for treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.

Published: Mar 24, 2025 | Category: FDA | Name: FDA Biologics

FDA Roundup: March 21, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Mar 21, 2025 | Category: FDA | Name: FDA Press Release

Administrative Guidances

This page lists Administrative Guidance documents.

Published: Mar 21, 2025 | Category: FDA | Name: FDA Biologics

Antimicrobial Resistance

Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.

Published: Mar 21, 2025 | Category: FDA | Name: FDA Drugs

CDER Pilot Grant Program: Standard Core Clinical Outcome Assessments (COAs) and their Related Endpoints

The U.S. Food and Drug Administration (FDA) has developed a Pilot Grant Program to support the development of publicly available core set(s) of Clinical Outcome Assessments (COAs) and their related endpoints for specific disease indications (RFA-FD-19-006).

Published: Mar 21, 2025 | Category: FDA | Name: FDA Drugs

Helpful Webinars and Other Resources for Generic Drug Manufacturers

FDA develops resources – workshops, webinars, and seminars – to help generic drug manufacturers improve the quality of their abbreviated new drug application (ANDA) submissions and decrease the number of assessment cycles needed for approval.

Published: Mar 21, 2025 | Category: FDA | Name: FDA Drugs

Notable Approvals | Drugs

News about human drug-related approvals

Published: Mar 20, 2025 | Category: FDA | Name: FDA Drugs

FDA approves first treatment for adults with complement 3 glomerulopathy, a rare kidney disease, to reduce proteinuria

Published: Mar 20, 2025 | Category: FDA | Name: FDA Drugs

Seindni Co., Ltd. - 533363 - 12/05/2017

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 20, 2025 | Category: FDA | Name: FDA Drugs

Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics

MCMi regulatory science project to research issues that are key to understanding and predicting if—and how—vaccines and therapeutics to prevent and treat Ebola will show efficacy

Published: Mar 20, 2025 | Category: FDA | Name: FDA Drugs

Center for Drug Evaluation and Research Organization Chart

Organization chart for the FDA's Center for Drug Evaluation and Research, including leadership roles.

Published: Mar 20, 2025 | Category: FDA | Name: FDA Drugs

Guidance and Other Information of Special Interest to MCM Stakeholders

Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear threats and emerging infectious diseases

Published: Mar 20, 2025 | Category: FDA | Name: FDA Drugs

Cleared 510(k) Submissions with Supporting Documents

Listing of cleared 510(k) submissions with supporting documents. Information is reflected as of the clearance date.

Published: Mar 20, 2025 | Category: FDA | Name: FDA Biologics

HHS, FDA Announce Chemical Contaminants Transparency Tool for Foods

Under the leadership of HHS Secretary Robert F. Kennedy, Jr., the FDA unveiled a Chemical Contaminants Transparency Tool providing an online searchable database providing a consolidated list of contaminant levels (e.g., tolerances, action levels, and guidance levels) that are used to evaluate potent

Published: Mar 20, 2025 | Category: FDA | Name: FDA Press Release

Guidance Recap Podcast | General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products

Guidance Recap Podcast: General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products

Published: Mar 20, 2025 | Category: FDA | Name: FDA Drugs

Compounding Quality Center of Excellence | Engage with the Compounding Quality Center of Excellence

Engage with the Compounding Quality Center of Excellence

Published: Mar 20, 2025 | Category: FDA | Name: FDA Drugs

FDA to Compounders: Know Your Bulks and Excipients Suppliers

FDA has identified several issues over the past few years related to repackers of bulk drug substances, also called active pharmaceutical ingredients (APIs), used to compound drugs. The agency urges compounders to know your bulks supplier and know if they are testing the drugs before you purchase bu

Published: Mar 20, 2025 | Category: FDA | Name: FDA Drugs

GDUFA Implementation Quarterly Meetings between FDA and Industry

FDA and representatives of the generic drug industry meet quarterly to discuss topics related to the implementation of GDUFA.

Published: Mar 20, 2025 | Category: FDA | Name: FDA Drugs

Planning an EL-PFDD Meeting

Published: Mar 20, 2025 | Category: FDA | Name: FDA Drugs

Condition-Specific Meeting Reports and Other Information Related to Patients' Experience

This webpage provides links to certain publicly available external reports and resources relating to patient experience data. The patient community, patient advocates, researchers, drug developers, and federal agencies may find these materials useful.

Published: Mar 20, 2025 | Category: FDA | Name: FDA Drugs

FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making

Published: Mar 20, 2025 | Category: FDA | Name: FDA Drugs

Verified Clinical Benefit | Cancer Accelerated Approvals

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the specific indication.

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Intrathecal Compounding Specialist, LLC - 610639 - 09/15/2020

Compounding Pharmacy/Adulterated Drug Products

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Front Door Pharmacy, LLC dba Pure Pharmacy - 608461 - 07/01/2020

Compounding Pharmacy/Adulterated Drug Products

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Nalpropion Pharmaceuticals LLC - 09/22/2020

False & Misleading Claims/Misbranded

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

HNC Products Inc. - 607359 - 09/10/2020

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy - 610384 - 09/08/2020

Compounding Pharmacy/Adulterated Drug Products

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Integrated Health Concepts Inc. dba Conversio Health - 610546 - 09/10/2020

Compounding Pharmacy/Adulterated Drug Products

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Coupler Enterprises - 607662 - 09/15/2020

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Mayon's Pharmaceuticals Pvt Ltd - 607388 - 09/04/2020

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

The Elderberry Co., LLC - 608837 - 09/08/2020

New Drug/Misbranded

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

klasiekpharmacy.com - 610293 - 08/31/2020

Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

lekapharma.com - 610220 - 08/31/2020

Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

bluepillmedications.com - 610250 - 09/02/2020

Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

alpharoyalpharmacy.com - 610241 - 09/02/2020

Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

genericpharmacyusa.com - 610252 - 08/31/2020

Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

greenrxpharmacy.com - 610254 - 08/31/2020

Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

IceNetworks Ltd./www.mega-pillspharmacy.com - 610218 - 08/31/2020

Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

www.roidsforce.com - 610217 - 08/31/2020

Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Thomas Meds - 609075 - 08/26/2020

Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Pharmacy Plus, Inc. dba Vital Care Compounder - 610477 - 09/09/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Banco Vida Corp. - 606288 - 08/12/2020

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

Vibrant Health Care, Inc. - 608426 - 11/18/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

Davati Medical Supply LLC - 615530 - 06/25/2021

Unapproved and Misbranded Product Related to Influenza Virus

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

Utah Cord Bank LLC - 614021 - 05/11/2021

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

Davati Medical Supply LLC - 615530 - 10/14/2021

Unapproved and Misbranded Product Related to Influenza Virus

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

Surgenex LLC - 615254 - 11/15/2021

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

Cooper Institute - 619233 - 12/15/2021

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

Reproductive Technologies, Inc. - 594292 - 12/03/2021

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

Toxikon Corporation/Labcorp Bedford LLC - 623581 - 02/10/2022

Good Laboratory Practice (GLP)

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

Smart Surgical, Inc dba Burst Biologics - 614361 - 02/02/2022

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

OsteoLife Biomedical I LLC - 626889 - 03/31/2022

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

Re-Gen Active Lab, Inc. - 620763 - 05/27/2022

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

FDA Roundup: September 29, 2023

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

On March 19, 2025, the FDA granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Phoenix Biotechnology, Inc. - 612178 - 12/15/2020

Finished Pharmaceuticals/Unapproved new drug

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

GOJO Industries Inc - 599132 - 11/30/2020

Unapproved New Drugs/Misbranded

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Custom Compounding Center - 481888 - 10/28/2020

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

University Rx Specialists Inc - 495985 - 12/11/2018

Unapproved New Drug/Compounding/Misbranding/Adulterated

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Civic Center Pharmacy Inc. - 453724 - 04/02/2019

CGMP/Compounded Drugs/Misbranding

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Oculo-Plastik, Inc. - 481113 - 05/08/2017

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Healthy Healing Enterprises, LLC - 554500 - 08/06/2019

New Drug/Labeling/Misbranded

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

PharmScript, LLC - 535618 - 07/29/2019

Drug Product/Adulterated

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Sprout Pharmaceuticals, Inc - 610569 - 08/31/2020

False & Misleading Claims/Misbranded

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Kalchem International, Inc. - 607098 - 08/27/2020

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

www.buydrugsmedsonline.com - 610292 - 08/31/2020

Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

www.xsteroids.com - 610203 - 08/31/2020

Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

melanopharmacy.com - 610314 - 09/02/2020

Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

www.uspharmacyshop.com - 610213 - 08/31/2020

Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

globalpharmacystores.com - 610342 - 09/02/2020

Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

www.rxeasymeds.com - 610216 - 08/31/2020

Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

www.skylimitpharmacy.com - 610215 - 08/31/2020

Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet

Published: Mar 19, 2025 | Category: FDA | Name: FDA Drugs

Lattice Biologics, Ltd. - 607852 - 08/27/2020

Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

Family Fertility Center - 588805 - 05/11/2020

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

Liveyon Labs Inc - 588399 - 12/05/2019

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

Susan P. King-Harris, D.P.M. - 591682 - 09/09/2019

Bioresearch Monitoring Program/IRB

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

Abington Memorial Hospital, IRC - 576854 - 08/28/2019

Bioresearch Monitoring Program/IRB

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

Invitrx Therapeutics Inc. - 581182 - 03/16/2020

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 19, 2025 | Category: FDA | Name: FDA Biologics

FDA Roundup: March 18, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Mar 18, 2025 | Category: FDA | Name: FDA Press Release

RAGWITEK

Product approval information for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen approved for use in adults 18 through 65 years of age.

Published: Mar 18, 2025 | Category: FDA | Name: FDA Biologics

HHS, FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable, and Nutritious Infant Formula for American Families

Under the leadership of HHS Secretary Robert F. Kennedy, Jr., the FDA is taking steps to enhance its efforts to ensure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply.

Published: Mar 18, 2025 | Category: FDA | Name: FDA Press Release

Kedbumin

Product approval information is indicated for: o Hypovolemic shock o Hypoalbuminemia o Prevention of central volume depletion after paracentesis due to cirrhotic ascites o Ovarian Hyperstimulation Syndrome (OHSS) o Adult Respiratory Distress Syndrome (ARDS) o Burns o Hemodialysis patients undergoin

Published: Mar 18, 2025 | Category: FDA | Name: FDA Biologics

Human Drug Compounding Outsourcing Facility Fees

Published: Mar 18, 2025 | Category: FDA | Name: FDA Drugs

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral

Indicated for active immunization for the prevention of febrile acute respiratory disease caused by Adenovirus Type 4 and Type 7

Published: Mar 18, 2025 | Category: FDA | Name: FDA Biologics

Waxhead Sun Defense Company - 688286 - 03/12/2025

OTC/Unapproved New Drug/Misbranded

Published: Mar 18, 2025 | Category: FDA | Name: FDA Drugs

Advanced Pharmaceutical Technology - 692576 - 03/14/2025

CGMP/Finished Pharmaceutical/Adulterated

Published: Mar 18, 2025 | Category: FDA | Name: FDA Drugs

Rite-Kem Incorporated - 697272 - 01/28/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 18, 2025 | Category: FDA | Name: FDA Drugs

Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi - 699000 - 03/12/2025

CGMP/Finished Pharmaceutical/Adulterated

Published: Mar 18, 2025 | Category: FDA | Name: FDA Drugs

Aspen Pharmacare Holdings Limited - 701671 - 02/24/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 18, 2025 | Category: FDA | Name: FDA Drugs

CoLabs Intl. Corp - 688285 - 03/12/2025

Unapproved New Drugs/Misbranded

Published: Mar 18, 2025 | Category: FDA | Name: FDA Drugs

International Laboratories Corp - 698522 - 03/10/2025

CGMP/Finished Pharmaceutical/Adulterated

Published: Mar 18, 2025 | Category: FDA | Name: FDA Drugs

MG Infusions - 696890 - 03/10/2025

CGMP/Deviations/Biologics License Application (BLA)

Published: Mar 18, 2025 | Category: FDA | Name: FDA Biologics

Kabana Skin Care - 688254 - 03/12/2025

Unapproved New Drugs/Misbranded

Published: Mar 18, 2025 | Category: FDA | Name: FDA Drugs

Vegewax Candleworx Ltd. - 675099 - 06/14/2024

CGMP/Finished Pharmaceutical/Adulterated

Published: Mar 18, 2025 | Category: FDA | Name: FDA Drugs

Mehran Michael Bahrami, M.D. - 703689 - 03/05/2025

Clinical Investigator

Published: Mar 18, 2025 | Category: FDA | Name: FDA Drugs

Laboratory Methods (Drugs)

Analytical laboratory methods developed and used by FDA to test certain drug quality attributes that also may impact safety.

Published: Mar 18, 2025 | Category: FDA | Name: FDA Drugs

CBER Advanced Technologies Team (CATT)

To provide an interactive mechanism within CBER for prospective innovators/developers of advanced manufacturing technologies to discuss the implementation of these technologies in the development of CBER-regulated products.

Published: Mar 18, 2025 | Category: FDA | Name: FDA Biologics

Quality Information for Applicants | Chemistry, Manufacturing, and Controls (NDAs, ANDAs, BLAs, and IND applications)

Published: Mar 18, 2025 | Category: FDA | Name: FDA Drugs

FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss

Published: Mar 17, 2025 | Category: FDA | Name: FDA Drugs

Industry Resources

Information to assist the drug manufacturing industry in the development of generic drugs and the completion of abbreviated new drug applications (ANDAs)

Published: Mar 17, 2025 | Category: FDA | Name: FDA Drugs

General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486

For use by biological product manufacturers to report biological product deviations (BPD) that may affect the safety, purity, or potency of a distributed product in accordance with 21 CFR, Part 600.14 or 606.171. Also for use by Human Cells, Tissues and Cellular and Tissue-Based Product (HCT/P) manu

Published: Mar 17, 2025 | Category: FDA | Name: FDA Biologics

Abbreviated New Drug Application (ANDA)

Abbreviated New Drug Applications and following the path to generic drug approval. Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants

Published: Mar 17, 2025 | Category: FDA | Name: FDA Drugs

Instructions for Using the eBPDR System

Published: Mar 17, 2025 | Category: FDA | Name: FDA Biologics

2024 NCTR Research Highlights

2024 NCTR Research Highlights and Accomplishments:

Published: Mar 17, 2025 | Category: FDA | Name: FDA Drugs

ProRx, LLC - 696742 - 03/04/2025

Compounding Pharmacy/Adulterated Drug Products

Published: Mar 17, 2025 | Category: FDA | Name: FDA Drugs

Safe Chain Solutions, LLC - 636044 - 03/10/2025

Drug Product/Adulterated

Published: Mar 17, 2025 | Category: FDA | Name: FDA Drugs

Safe Chain Solutions, LLC - 636044 - 06/08/2023

Drug Product/Adulterated

Published: Mar 17, 2025 | Category: FDA | Name: FDA Drugs

CDER - Biological Product Deviations

Published: Mar 14, 2025 | Category: FDA | Name: FDA Drugs

La FDA advierte que los medios de contraste basados en gadolinio (MCBG) se depositan en el cuerpo y exige una nueva clase de advertencias

Published: Mar 14, 2025 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings

FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has no

Published: Mar 14, 2025 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings

An FDA review found the side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) are lower than previously suspected. These risks still exist, but we believe the benefits of quitting smoking outweigh them.

Published: Mar 14, 2025 | Category: FDA | Name: FDA Drugs

Information by Drug Class

FDA provides consumers and industry with safety, regulatory and availability information for various drugs by drug class. From A to Z. Topics include: acetaminophen, estrogen, insulin, opioids, statins, and weight-loss drugs.

Published: Mar 14, 2025 | Category: FDA | Name: FDA Drugs

Frequently Asked Questions About Therapeutic Biological Products

Published: Mar 14, 2025 | Category: FDA | Name: FDA Drugs

Drug Safety Oversight Board Meetings - Public Summaries

This page provides summaries of past DSB Meetings. Each summary include DSCs posted since the last meeting, topics presented and discussed with the Board. Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of his/her respective federal agency or Inst.

Published: Mar 14, 2025 | Category: FDA | Name: FDA Drugs

Products Approved for Anthrax

Discover FDA-approved products for anthrax preparedness and response. Get essential information on vaccines, treatments, and preventive measures to protect public health from bioterrorism threats like anthrax.

Published: Mar 14, 2025 | Category: FDA | Name: FDA Drugs

AFLURIA , AFLURIA SOUTHERN HEMISPHERE

For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

Published: Mar 14, 2025 | Category: FDA | Name: FDA Biologics

FDA Roundup: March 14, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Mar 14, 2025 | Category: FDA | Name: FDA Press Release

FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)

Published: Mar 14, 2025 | Category: FDA | Name: FDA Drugs

Novel Drug Approvals for 2022

Innovative drugs often mean new treatment options for patients and advances in health care for the American public.

Published: Mar 14, 2025 | Category: FDA | Name: FDA Drugs

CDER Conversations

Interviews with experts from FDA's Center for Drug Evaluation and Research (CDER) on priorities, projects, and initiatives.

Published: Mar 14, 2025 | Category: FDA | Name: FDA Drugs

What You Should Know about Eye Drops

Ophthalmic drug products, such as eye drops, pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Any drug used in the eyes must be sterile to reduce the risk of infection. Eye drops are available by prescription or sold as OTCs.

Published: Mar 14, 2025 | Category: FDA | Name: FDA Drugs

Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere, Fluzone High-Dose Quadrivalent Southern Hemisphere

For active immunization of persons 6 months of age and older for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

Published: Mar 14, 2025 | Category: FDA | Name: FDA Biologics

FDA Educational Efforts Prevented Nearly 450,000 Youth from Starting E-Cigarette Use in One Year

A study co-authored by U.S. Food and Drug Administration scientists was released showing the agency’s youth e-cigarette prevention campaign, “The Real Cost,” successfully reduced e-cigarette use among youth.

Published: Mar 14, 2025 | Category: FDA | Name: FDA Press Release

Dr. Reddy’s Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., Due to Mislabeling of Infusion Bag

Dr. Reddy’s Laboratories Ltd is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags to the consumer level, in the United States.

Published: Mar 13, 2025 | Category: FDA | Name: FDA Drugs

Drug Shortages

Drug Shortages Homepage

Published: Mar 13, 2025 | Category: FDA | Name: FDA Drugs

Project Orbis

Information Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE) that provides a framework for concurrent submission and review of oncology products among international partners.

Published: Mar 13, 2025 | Category: FDA | Name: FDA Drugs

Allergy Relief for Your Child

When a child’s sniffles and sneezes won’t go away for weeks, the cause might be allergies. The FDA regulates prescription and OTC medicines that offer allergy relief, plus allergen extracts to diagnose and treat allergies. Read and follow the directions when giving any medicine to children.

Published: Mar 13, 2025 | Category: FDA | Name: FDA Drugs

Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)

As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare Diseases Team inaugurated the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) initiative. Learn more.

Published: Mar 13, 2025 | Category: FDA | Name: FDA Drugs

ALTUVIIIO

For adults and children with Hemophilia A (congenital Factor VIII deficiency) for: (1) Routine prophylaxis to reduce the frequency of bleeding episodes; (2) On-demand treatment and control of bleeding episodes; and (3) Perioperative management of bleeding.

Published: Mar 12, 2025 | Category: FDA | Name: FDA Biologics

Supporting Clinical Practice Guidelines for Drugs with Abuse Potential

Information regarding the FDA's efforts to support the development of clinical practice guidelines for drugs with abuse potential.

Published: Mar 12, 2025 | Category: FDA | Name: FDA Drugs

CBER Rare Disease Program

Description of CBER's Rare Disease Program, including a description of the program, selected activities, examples of collaborations internal and external to CBER, and frequently asked questions.

Published: Mar 12, 2025 | Category: FDA | Name: FDA Biologics

CBER 2025 Orphan Approvals (new BLAs)

Published: Mar 12, 2025 | Category: FDA | Name: FDA Biologics

How to Report a Shortage or Supply Issue

Published: Mar 12, 2025 | Category: FDA | Name: FDA Drugs

Nonprescription Drugs Advisory Committee Roster

This page contains the Nonprescription Drugs Advisory Committee Roster, which lists the current members and the current number of vacancies for the committee.

Published: Mar 12, 2025 | Category: FDA | Name: FDA Drugs

Food and Drug Administration Overdose Prevention Framework

Working across the Agency, FDA’s Overdose Prevention priorities closely align with HHS and bring together our ongoing and proposed activities to strengthen FDA’s role in combatting the drug overdose crisis, including opioids.

Published: Mar 12, 2025 | Category: FDA | Name: FDA Drugs

Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis

Published: Mar 12, 2025 | Category: FDA | Name: FDA Drugs

Q&A with FDA Podcast

“Q&A with FDA” is a monthly podcast series that provides engaging conversation and discussion about the latest regulatory topics. In this podcast series, FDA’s Division of Drug Information will answer some of the most commonly asked questions received by FDA. Perhaps you have had the same questions

Published: Mar 12, 2025 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Podcasts

FDA Drug Safety Podcasts are produced by FDA's Center for Drug Evaluation and Research (CDER)

Published: Mar 12, 2025 | Category: FDA | Name: FDA Drugs

Limited number of voluntary recalls initiated after FDA testing of acne products for benzene; findings show a small number of products with elevated levels of benzene contamination

Voluntary recalls of acne products after FDA testing finds small number of proudcts with elevated levels of benzene

Published: Mar 11, 2025 | Category: FDA | Name: FDA Drugs

FDA Roundup: March 11, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Mar 11, 2025 | Category: FDA | Name: FDA Press Release

Office of Generic Drugs | Offices and Divisions

Generic Drugs Offices and Divisions

Published: Mar 11, 2025 | Category: FDA | Name: FDA Drugs

Zhejiang Tianyu Pharmaceutical Co Ltd - 631054 - 02/28/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Mar 11, 2025 | Category: FDA | Name: FDA Drugs

Zhejiang Tianyu Pharmaceutical Co., Ltd. - 631054 - 08/17/2022

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Mar 11, 2025 | Category: FDA | Name: FDA Drugs

Orange Book Data Files

Data Descriptions updated (February 24, 2017)

Published: Mar 11, 2025 | Category: FDA | Name: FDA Drugs

Natuzen Co., Ltd. - 677942 - 03/03/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 11, 2025 | Category: FDA | Name: FDA Drugs

Natuzen Co., Ltd. - 677942 - 05/03/2024

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 11, 2025 | Category: FDA | Name: FDA Drugs

Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA

This Table provides the current number of active CDER Drug Development Tool (DDT) Qualification projects overall and by Program (DDT- Animal Model Qualification Program, DDT- Biomarker Qualification Program, DDT- Clinical Outcomes Assessment [COA] Qualification Program). Numbers are also provided by

Published: Mar 11, 2025 | Category: FDA | Name: FDA Drugs

Abbreviated New Drug Application (ANDA) Forms and Submission Requirements

This page is a resource for ANDA Forms and Submission Requirements

Published: Mar 11, 2025 | Category: FDA | Name: FDA Drugs

Generic Drug Development

News and Announcements updated

Published: Mar 11, 2025 | Category: FDA | Name: FDA Drugs

Science & Research

In collaboration with industry and the public, FDA creates an annual list of regulatory science initiatives on generic drugs.

Published: Mar 11, 2025 | Category: FDA | Name: FDA Drugs

Pico IV Inc. - 700591 - 03/06/2025

Unapproved New Drugs/Misbranded

Published: Mar 11, 2025 | Category: FDA | Name: FDA Drugs

Shree Jaya Laboratories PVT. LTD. - 698690 - 02/28/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Mar 11, 2025 | Category: FDA | Name: FDA Drugs

Linghai ZhanWang Biotechnology Co., Ltd - 697983 - 02/25/2025

CGMP/Finished Pharmaceutical/Adulterated

Published: Mar 11, 2025 | Category: FDA | Name: FDA Drugs

Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC): Voluntary Lot Withdrawals - Due to Increased Reports of Allergic/Hypersensitivity Reactions

As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.

Published: Mar 11, 2025 | Category: FDA | Name: FDA Biologics

FDA’s Labeling Resources for Human Prescription Drugs

Published: Mar 10, 2025 | Category: FDA | Name: FDA Drugs

GDUFA Paid Facilities List

This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list:

Published: Mar 7, 2025 | Category: FDA | Name: FDA Drugs

FDA Roundup: March 7, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Mar 7, 2025 | Category: FDA | Name: FDA Press Release

Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format

Guidance for Industry - Labeling

Published: Mar 7, 2025 | Category: FDA | Name: FDA Drugs

Activities Report of the Generic Drug Program (FY 2024) – FDARA Title VIII Sections 807 and 805

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs).

Published: Mar 7, 2025 | Category: FDA | Name: FDA Drugs

Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs).

Published: Mar 7, 2025 | Category: FDA | Name: FDA Drugs

Frequently Requested or Proactively Posted Compliance Records

Frequently requested inspection records of foreign pharmaceutical manufacturing facilities

Published: Mar 7, 2025 | Category: FDA | Name: FDA Drugs

Berkeley Nutritional Mfg Corp. - 500324 - 01/31/2017

CGMP/Finished Pharmaceuticals/Adulterated/Misbranded

Published: Mar 7, 2025 | Category: FDA | Name: FDA Drugs

NutraCore Health Products - 542906 - 09/11/2018

Close Out Letter

Published: Mar 7, 2025 | Category: FDA | Name: FDA Drugs

Choice Detox Center, Inc. dba Nofeel - 543456 - 09/11/2018

Finished Pharmaceuticals/Unapproved New Drug/Misbranded

Published: Mar 7, 2025 | Category: FDA | Name: FDA Drugs

Best Bentonite - 494502 - 11/23/2018

Unapproved New Drugs/Misbranded

Published: Mar 7, 2025 | Category: FDA | Name: FDA Drugs

List of Determinations Including Written Request

In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a pediatric exclusivity determination was made, on or after September 27, 2007.

Published: Mar 6, 2025 | Category: FDA | Name: FDA Drugs

Signature Biologics, LLC - 631039 - 02/21/2025

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 6, 2025 | Category: FDA | Name: FDA Biologics

Signature Biologics, LLC - 631039 - 09/18/2023

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Mar 6, 2025 | Category: FDA | Name: FDA Biologics

The Bad Ad Program

Published: Mar 6, 2025 | Category: FDA | Name: FDA Drugs

October - December 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Signals of Serious Risks (FAERS)

Published: Mar 5, 2025 | Category: FDA | Name: FDA Drugs

October - December 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Signals of Serious Risks (FAERS)

Published: Mar 5, 2025 | Category: FDA | Name: FDA Drugs

July - September 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Signals of Serious Risks (FAERS)

Published: Mar 5, 2025 | Category: FDA | Name: FDA Drugs

April - June 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Signals of Serious Risks (FAERS)

Published: Mar 5, 2025 | Category: FDA | Name: FDA Drugs

January - March 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Signals of Serious Risks (FAERS)

Published: Mar 5, 2025 | Category: FDA | Name: FDA Drugs

July - September 2019 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Signals of Serious Risks (FAERS)

Published: Mar 5, 2025 | Category: FDA | Name: FDA Drugs

Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)

Discover potential signals of serious risks and new safety information identified by the FDA's Adverse Event Reporting System (FAERS). Learn how the FDA monitors and evaluates drugs for safety concerns, providing important updates on adverse events to protect public health.

Published: Mar 5, 2025 | Category: FDA | Name: FDA Drugs

An Update on Sunscreen Requirements: The Deemed Final Order and the Proposed Order

FDA is posting the deemed final order for over-the-counter (OTC) sunscreens and is issuing a proposed order for sunscreens. This explains today’s activities and what the orders mean for consumers, health care providers, industry, and other stakeholders.

Published: Mar 5, 2025 | Category: FDA | Name: FDA Drugs

Pediatric Exclusivity Granted

Approved active drugs with sponsors to which FDA has granted exclusivity for pediatric studies under Section 505A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Published: Mar 5, 2025 | Category: FDA | Name: FDA Drugs

FDA Roundup: March 4, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Mar 4, 2025 | Category: FDA | Name: FDA Press Release

Other Meeting Options Related to Human Drugs

Learn more about established meeting request processes for different types of meeting options related to human drugs.

Published: Mar 4, 2025 | Category: FDA | Name: FDA Drugs

Personal Importation

Published: Mar 4, 2025 | Category: FDA | Name: FDA Drugs

Importing Human Drugs

FDA importing requirements for human drug products,

Published: Mar 4, 2025 | Category: FDA | Name: FDA Drugs

Navigating Controlled Correspondences to Support Generic Drug Development - 02/27/2025

Navigating Controlled Correspondences to Support Generic Drug Development

Published: Mar 4, 2025 | Category: FDA | Name: FDA Drugs

Untitled Letters

These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion's untitled letters. FDA may have redacted or edited some of the letters to remove confidential information.

Published: Mar 4, 2025 | Category: FDA | Name: FDA Drugs

Granules India Limited - 697115 - 02/26/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 4, 2025 | Category: FDA | Name: FDA Drugs

TKTX Numbing Cream USA - 702106 - 02/25/2025

Unapproved New Drugs/Misbranded

Published: Mar 4, 2025 | Category: FDA | Name: FDA Drugs

TKTX Store - 698371 - 02/25/2025

Unapproved New Drugs/Misbranded

Published: Mar 4, 2025 | Category: FDA | Name: FDA Drugs

TKTX Numb Store - 697051 - 02/25/2025

Drug Products/Adulterated/Misbranded

Published: Mar 4, 2025 | Category: FDA | Name: FDA Drugs

TKTX USA - 698435 - 02/25/2025

Unapproved New Drugs/Misbranded

Published: Mar 4, 2025 | Category: FDA | Name: FDA Drugs

Chem-Tech, Ltd. - 696920 - 02/11/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Mar 4, 2025 | Category: FDA | Name: FDA Drugs

One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalaﬁl

One Source Nutrition is voluntarily recalling all lots of Vitality capsules to the Consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are ingredients in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as

Published: Mar 4, 2025 | Category: FDA | Name: FDA Drugs

My Dog Has Cancer: What Do I Need to Know?

Just as FDA reviews drugs for humans for safety and effectiveness before they can go on the market, the agency does the same for treatments for animals. Learn how FDA brings new oncology treatments to market and questions to ask your vet about your dog's cancer diagnosis.

Published: Mar 3, 2025 | Category: FDA | Name: FDA Drugs

Mixing Medications and Dietary Supplements Can Endanger Your Health

Dietary supplements may contain ingredients that can have strong effects in the body. Talk with a health care professional before taking supplements.

Published: Mar 3, 2025 | Category: FDA | Name: FDA Drugs

Generic Drugs Forum (GDF) 2025 - 04/09/2025

Join us at the annual Generic Drugs Forum, a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generic medicines.

Published: Mar 3, 2025 | Category: FDA | Name: FDA Drugs

Meeting Presentations | Drugs

Meeting Presentations. CDER professionals participate in several meetings, conferences and workshops throughout the year. Appealing primarily to the pharmaceutical industry and health care professionals, topics can range from users fees, to drug advertising and marketing, to genomics, to over-the-co

Published: Mar 3, 2025 | Category: FDA | Name: FDA Drugs

Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality

The New Drugs Regulatory Program Modernization’s reorganization of the Office of New Drugs (OND), with corresponding changes to the Office of Translational Sciences (OTS) and the Office of Pharmaceutical Quality (OPQ)

Published: Mar 3, 2025 | Category: FDA | Name: FDA Drugs

Frequently Asked Questions on Benzene Contamination in Drugs

FDA provides answers to frequently asked questions on benzene contamination in drugs

Published: Mar 3, 2025 | Category: FDA | Name: FDA Drugs

Seasonal Information for Influenza Virus Vaccine

Published: Feb 28, 2025 | Category: FDA | Name: FDA Biologics

FDA Plans for Selecting Influenza Virus Strains for Vaccine Composition for the 2025-2026 U.S. Influenza Season

Published: Feb 28, 2025 | Category: FDA | Name: FDA Biologics

FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use

[03-03-2015] The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions.

Published: Feb 28, 2025 | Category: FDA | Name: FDA Drugs

FDA Roundup: February 28, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Feb 28, 2025 | Category: FDA | Name: FDA Press Release

FDA issues class-wide labeling changes for testosterone products

FDA issues labeling changes for all testosterone products following conclusion of ambulatory blood pressure monitoring studies and TRAVERSE trial,

Published: Feb 28, 2025 | Category: FDA | Name: FDA Drugs

CDER Small Business & Industry Assistance (SBIA)

A Comprehensive Resource for Information on Human Drug Development in Regulation

Published: Feb 28, 2025 | Category: FDA | Name: FDA Drugs

Generic Drugs Program Activities Report - FY 2024 Monthly Performance

Published: Feb 28, 2025 | Category: FDA | Name: FDA Drugs

Generic Drugs Program Monthly and Quarterly Activities Report

Monthly and quarterly metrics of the FDA Generic Drugs Program.

Published: Feb 28, 2025 | Category: FDA | Name: FDA Drugs

Weight Loss, Male Enhancement and Other Products Sold Online or in Stores May Be Dangerous

Consumers cannot be confident that certain products, including weight loss and male enhancement products, sold on online marketplaces like Amazon and eBay or in stores, are safe to use.

Published: Feb 28, 2025 | Category: FDA | Name: FDA Drugs

Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions - 03/13/2025

Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions

Published: Feb 28, 2025 | Category: FDA | Name: FDA Drugs

Prescription Drug User Fee Amendments

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

Published: Feb 28, 2025 | Category: FDA | Name: FDA Drugs

UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee - 12/04/2024

This meeting is scheduled to start at approximately 8 a.m. Eastern Time and will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.

Published: Feb 28, 2025 | Category: FDA | Name: FDA Drugs

Grapefruit Juice and Some Drugs Don't Mix

Grapefruit juice and grapefruit can affect the way your medicines work, and that food and drug interaction can cause problems. The severity of the interaction can be different depending on the person, the drug, and the amount of grapefruit juice you drink.

Published: Feb 28, 2025 | Category: FDA | Name: FDA Drugs

Jobs at CDER Frequently Asked Questions

Frequently Asked Questions about GDUFA Hiring Initiative

Published: Feb 27, 2025 | Category: FDA | Name: FDA Drugs

POSTPONED - Optimizing Pregnancy Registries - 03/27/2025

Public workshop is part of FDA’s commitment to advance optimal approaches to efficient generation of high-quality human safety data for drug products used during pregnancy.

Published: Feb 27, 2025 | Category: FDA | Name: FDA Drugs

ODACTRA

Product approval information for use in adults 18 through 65 years of age as immunotherapy for house dust mite- (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust m

Published: Feb 27, 2025 | Category: FDA | Name: FDA Biologics

Pathways for Students and Recent Graduates

Pathways for Students and Recent Graduates

Published: Feb 27, 2025 | Category: FDA | Name: FDA Drugs

Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act - 05/15/2025

Published: Feb 27, 2025 | Category: FDA | Name: FDA Drugs

Ongoing | Cancer Accelerated Approvals

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.

Published: Feb 27, 2025 | Category: FDA | Name: FDA Drugs

Vivotif

For immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi.

Published: Feb 27, 2025 | Category: FDA | Name: FDA Biologics

Natural Dior LLC Issues Voluntary Nationwide Recall of Vitafer-L Gold Liquid Due to Presence of Undeclared Tadalafil

February 25, 2025 – Natural Dior LLC, is voluntarily recalling the affected lots of Vitafer-L Gold Liquid, a dietary supplement with iron and vitamins, to the consumer level. The product has been found to contain undeclared tadalafil, an ingredient in FDA approved products for treatment of male erec

Published: Feb 27, 2025 | Category: FDA | Name: FDA Drugs

MTS Anti-IgG, -C3d Card

Indicated For in vitro blood banking reagent

Published: Feb 26, 2025 | Category: FDA | Name: FDA Biologics

Hospira, Inc. Issues a Voluntary Nationwide Recall for 4.2% Sodium Bicarbonate Injection, USP and 1% and 2% Lidocaine HCl Injection, USP Due to the Potential for Presence of Glass Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10mL vial; 1% Lidocaine HCl Injection, USP, 50 mg/5mL vial; and 2% Lidocaine HCl Injection, USP, 100 mg/5mL vial to the user level. The recall was initiated d

Published: Feb 26, 2025 | Category: FDA | Name: FDA Drugs

Artificial Intelligence and Machine Learning (AI/ML) for Biological and Other Products Regulated by CBER

Use of Artificial Intelligence and Machine Learning (AI/ML) has rapidly become an important component of everyday life. This includes using AI/ML in the development of Medical Products, including Biologics. This page provides an overview of CBER's activity in AI/ML.

Published: Feb 26, 2025 | Category: FDA | Name: FDA Biologics

Questions and Answers: Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations

Published: Feb 26, 2025 | Category: FDA | Name: FDA Drugs

Benefits of Emerging Technology Program (ETP)

CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.

Published: Feb 26, 2025 | Category: FDA | Name: FDA Drugs

Transcript: Emerging Technology Program

FDA’s Emerging Technology Program is intended to encourage technology for use in product design and pharmaceutical manufacturing

Published: Feb 26, 2025 | Category: FDA | Name: FDA Drugs

Advancing Product Quality

FDA is engaged in efforts to encourage innovations in manufacturing processes and technology and to foster a quality management system.

Published: Feb 26, 2025 | Category: FDA | Name: FDA Drugs

Advancing Product Quality for Human Drugs

FDA is engaged in efforts to encourage innovations in manufacturing processes and technology and to foster a quality management system.

Published: Feb 26, 2025 | Category: FDA | Name: FDA Drugs

Advances in FDA's Drug Safety Programs

Drug Safety is a Key Priority at the Center for Drug Evaluation and Research

Published: Feb 26, 2025 | Category: FDA | Name: FDA Drugs

ACAM2000

ACAM2000 is a product approval indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

Published: Feb 26, 2025 | Category: FDA | Name: FDA Biologics

Central Admixture Pharmacy Services (CAPS) Issues Nationwide Recall of Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags Due to Visible Black Particulate Matter in a Single-Sealed Vial

February 24, 2025 – Bethlehem, PA. Central Admixture Pharmacy is recalling three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags (NDC: 71285-6092-1) to the hospital level. The product is being recalled because CAPS was notified by their raw material supplier of

Published: Feb 25, 2025 | Category: FDA | Name: FDA Drugs

Oncologic Drugs Advisory Committee Roster

ODAC roster, a lists the current members and the current number of vacancies for the committee

Published: Feb 25, 2025 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA modifies monitoring for neutropenia associated with schizophrenia medicine clozapine; approves new shared REMS program for all clozapine medicines

[09-15-2015] The U.S. Food and Drug Administration (FDA) is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia drug clozapine, to address continuing safety concerns and current knowledge about a serious blood condition called severe neutropen

Published: Feb 25, 2025 | Category: FDA | Name: FDA Drugs

Ascent Consumer Products Inc. Issues Voluntary Nationwide Recall of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System Due to Microbial Contamination

02/25/2025 Melville, NY. Ascent Consumer Products Inc. is voluntarily recalling one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System to the consumer level. The recall is being initiated due to a confirmed test result of microbial contamination of the product with Staphylococcus aureus (S

Published: Feb 25, 2025 | Category: FDA | Name: FDA Drugs

Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act

Published: Feb 25, 2025 | Category: FDA | Name: FDA Drugs

Frequently Asked Questions | Clozapine REMS Modification

The Clozapine REMS is a shared system REMS for all approved clozapine products.

Published: Feb 25, 2025 | Category: FDA | Name: FDA Drugs

Information on Clozapine

Published: Feb 25, 2025 | Category: FDA | Name: FDA Drugs

Sperm Bank, Inc. dba Fertility Center of California - 694273 - 02/14/2025

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Feb 25, 2025 | Category: FDA | Name: FDA Biologics

Emerging Technology Program (ETP)

CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.

Published: Feb 24, 2025 | Category: FDA | Name: FDA Drugs

FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs

FDA is evaluating the root cause of benzene contamination in certain drugs and alerting drug manufacturers to the risk of benzene contamination from drug components and other potential risk factors

Published: Feb 24, 2025 | Category: FDA | Name: FDA Drugs

Frequently requested or proactively posted drug-specific and other records

Published: Feb 24, 2025 | Category: FDA | Name: FDA Drugs

Office of Prescription Drug Promotion (OPDP) Metrics

FDA believes it is critically important to ensure that the promotional messages companies use to introduce new drugs are accurate and balanced as these messages form the public’s first impression of new drugs.

Published: Feb 24, 2025 | Category: FDA | Name: FDA Drugs

FDA 101: How to Use the Consumer Complaint System and MedWatch

If you have a complaint about a product regulated by the Food and Drug Administration (FDA), the agency wants to hear about it.

Published: Feb 24, 2025 | Category: FDA | Name: FDA Drugs

Internet Pharmacy Warning Letters

Rogue online pharmacies offer potentially dangerous prescription drugs to U.S. consumers. FDA has issued warning letters informing the website operators that they are engaged in illegal activity in violation of the U.S. Federal Food, Drug, and Cosmetic Act

Published: Feb 24, 2025 | Category: FDA | Name: FDA Drugs

Avoid Dangerous HCG Diet Products

FDA advises consumers to avoid human chorionic gonadotropin (HCG) weight-loss products.

Published: Feb 24, 2025 | Category: FDA | Name: FDA Drugs

ABRYSVO

ABRYSVO is an active immunization for the prevention of LRTD caused by RSV in individuals 60 years of age and older...

Published: Feb 21, 2025 | Category: FDA | Name: FDA Biologics

Treating and Preventing Head Lice

Head lice affect millions of children every year. Although head lice are a year-round problem, cases usually peak during back-to-school time. FDA-approved treatments for head lice include over-the-counter and prescription drugs.

Published: Feb 21, 2025 | Category: FDA | Name: FDA Drugs

A Recipe for Danger: Social Media Challenges Involving Medicines

Social media trends and peer pressure can be a dangerous combination to children, especially when involving misusing medicines. Nonprescription drugs are readily available in many homes, making these challenges even riskier. Warn your children about the dangers of misusing medicines.

Published: Feb 21, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves First Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disease

The FDA approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug to treat CTX, a very rare lipid storage disease.

Published: Feb 21, 2025 | Category: FDA | Name: FDA Press Release

Biological Approvals by Year

A collection of biological approval information organized by year and regulatory authorities.

Published: Feb 21, 2025 | Category: FDA | Name: FDA Biologics

FDA Warns of Use of Selective Androgen Receptor Modulators (SARMs) Among Teens, Young Adults

Targeting teenagers and young adults, videos on social media platforms promote the unsafe use of SARMs to improve physical appearance, gain muscle mass, or increase athletic performance.

Published: Feb 21, 2025 | Category: FDA | Name: FDA Drugs

FDA Pharmacists Help You Use Medicines Safely

Whether at your local pharmacy or the FDA, pharmacists help patients achieve the best possible outcome when taking drugs. Pharmacists are a bridge between the patient and their prescriber. They are experts at interpreting information for patients.

Published: Feb 21, 2025 | Category: FDA | Name: FDA Drugs

Patient Listening Session Summaries

Published: Feb 21, 2025 | Category: FDA | Name: FDA Drugs

eCTD Submission Standards for eCTD v4.0 and Regional M1

A listing of the Implementation Guides, Specifications, and Documentation that support the FDA implementation for eCTD v4.0

Published: Feb 21, 2025 | Category: FDA | Name: FDA Drugs

Withdrawn | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals

This listing includes accelerated approvals (AAs) for non-malignant hematological, neurological, and other disorder indications with postmarketing trials that have been subsequently withdrawn, and are therefore, no longer FDA-approved.

Published: Feb 21, 2025 | Category: FDA | Name: FDA Drugs

One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalaﬁl

Benton, Arkansas – 02/2019/2025 –One Source Nutrition is voluntarily recalling all lots of Vitality capsules to the Consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are ingredients in FDA approved products for treatment of male erectile dysfunctio

Published: Feb 21, 2025 | Category: FDA | Name: FDA Drugs

OTP Events, Meetings, and Workshops

Office of Therapeutic Products Events, Meetings, and Workshops

Published: Feb 20, 2025 | Category: FDA | Name: FDA Biologics

Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems

FDA warns that untreated constipation caused by schizophrenia drug clozapine (Clozaril) can get worse and lead to serious bowel problems that might require hospitalization or even cause death

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder

FDA recommends discussing the opioid reversal medicine naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder. Also consider prescribing naloxone to those at increased risk of opioid overdose.

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class

Includes warnings about the risks of abuse, addiction, dependence, and withdrawal.

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

Drug Safety and Availability

links to Drug Safety and Availability information

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)

FDA warns against taking higher than recommended doses of over-the-counter Benadryl, which can lead to serious problems and death. We are aware of news reports of teens misusing the drug after participating in “Benadryl Challenge” on TikTok

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid

FDA warns that NSAID use at 20 weeks or later in pregnancy may cause serious kidney problems in an unborn baby, leading to low amniotic fluid levels. Do not take NSAIDs unless advised to do so by your health care professional.

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)

Preliminary safety trial results show an increased risk of serious heart-related problems and cancer with Xeljanz, Xeljanz XR (tofacitinib). FDA will evaluate the results. Patients should not stop taking the medicine without first talking to their health care professionals.

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harm

FDA warns that abuse and misuse of the over-the-counter nasal decongestant propylhexedrine causes serious heart and mental health problems, disability or death. Only use propylhexedrine according to the directions on the Drug Facts label.

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease

Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease. FDA now requiring studies to evaluate heart risk across the drug class

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

Due to risk of serious liver injury, FDA restricts use of Ocaliva (obeticholic acid) in primary biliary cholangitis (PBC) patients with advanced cirrhosis

Due to risk of serious liver injury, FDA restricts use of Ocaliva (obeticholic acid) in primary biliary cholangitis (PBC) patients with advanced cirrhosis; adding and updating warnings

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

FDA warns that vapors from alcohol-based hand sanitizers can have side effects

FDA warns that headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin and breathing in the vapors that linger. Use in a well-ventilated area and tell consumers to read the Drug Facts label.

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins

FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy. Despite this change, discontinue statins in most pregnant patients or consider the ongoing therapeutic needs of the individual patient.

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions

Final study results show risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury

FDA is warning that getting alcohol-based hand sanitizer in the eyes can cause serious injury. If this occurs, immediately rinse with running water for 15 to 20 minutes

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

Continuing Education Live Events

Continuing Education Topics in Public Health

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

Have You Given Blood Lately?

The FDA works to ensure the safety of millions of units of blood and blood components donated in the U.S. each year. Learn how the FDA helps safeguard the blood supply and how you can donate blood.

Published: Feb 20, 2025 | Category: FDA | Name: FDA Biologics

Patent Certifications and Suitability Petitions

Information on patents and suitability petitions that impact the availability of generic drugs.

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

September 9, 2024: Meeting of the Antimicrobial Drugs Advisory Committee Meeting Announcement - 09/09/2024

September 9, 2024: Meeting of the Antimicrobial Drugs Advisory Committee Meeting Announcement

Published: Feb 20, 2025 | Category: FDA | Name: FDA Drugs

FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain

FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. Despite these risks, buprenorphine is an important treatment option for opioid use disorder (OUD) and pain, and the benefits of these medicines clearly outweigh the risks.

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)

FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib), which is approved to treat two specific types of lymphomas. Patients and health care professionals should discuss the risks and benefits of Ukoniq.

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging

Based on our recent review of published studies, FDA is recommending that newborns and children through 3 years old have follow-up thyroid monitoring within 3 weeks after receiving injections of contrast media containing iodine for X-rays and other medical imaging procedures.

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns

Due to safety concerns, FDA is withdrawing its approval for the cancer medicine Ukoniq (umbralisib), which was approved to treat two specific types of lymphoma&#58; marginal zone lymphoma (MZL) and follicular lymphoma (FL).

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)

FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib). Consider risks and benefits of continued use versus other treatments.

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause

FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause. Stop medicine if signs and symptoms of liver injury occur.

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

FDA adds Boxed Warning about a rare but serious allergic reaction called anaphylaxis with the multiple sclerosis medicine glatiramer acetate (Copaxone, Glatopa)

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

2017 Drug Safety Communications

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

2018 Drug Safety Communications

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

2019 Drug Safety Communications

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

Namita A. Goyal, M.D. - 677324 - 02/04/2025

Clinical Investigator

Published: Feb 19, 2025 | Category: FDA | Name: FDA Biologics

Namita A. Goyal, M.D. - 677324 - 10/10/2024

Clinical Investigator

Published: Feb 19, 2025 | Category: FDA | Name: FDA Biologics

5 Medication Safety Tips for Older Adults

As we age, physical changes can affect the way our body handles medications and how medicines work, which can lead to complications. Even if your medications have worked well for you over the years, they might need to be adjusted or changed later in life. Here are some important safety tips.

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

2020 Drug Safety Communications

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

2021 Drug Safety Communications

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

2022 Drug Safety Communications

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

Taking Z-drugs for Insomnia? Know the Risks

If you’re lying awake night after night, unable to sleep, you may want to talk to your health care professional about it. They may prescribe insomnia medicines approved by the FDA. Sometimes known as “Z-drugs,” they might help you get a good night’s sleep. But as with any medicine, there are risks.

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

2023 Drug Safety Communications

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

2024 Drug Safety Communications

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

Drug Safety Communications

FDA Drug Safety Communications connect consumers and health care professionals to important drug safety information. The webpage contains the most recent Drug Safety Communications from FDA as well as links for Early Communications, Follow-Up Early Communications, Information for Healthcare Professi

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

Ongoing | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals

Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

Fluorouracil and Pet Safety

Fluorouracil, used to treat a variety of conditions, is deadly if ingested by your pet. Store this common medication where pets cannot access it.

Published: Feb 19, 2025 | Category: FDA | Name: FDA Drugs

Safety & Availability (Biologics)

Important information about the safety and availability of biological products.

Published: Feb 18, 2025 | Category: FDA | Name: FDA Biologics

Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under

Published: Feb 18, 2025 | Category: FDA | Name: FDA Biologics

Always Tired? You May Have Sleep Apnea

If you feel tired and exhausted when you wake up every morning you may have sleep apnea. Find out more about the different types of FDA-cleared and FDA-approved obstructive sleep apnea or OSA treatments that work and help you get restful and restorative sleep.

Published: Feb 18, 2025 | Category: FDA | Name: FDA Drugs

BD Announces Voluntary Worldwide Recall for One Lot of ChloraPrep™ Clear 1 mL Applicators Due to Fungal Contamination

BD (Becton, Dickinson and Company) today announced the voluntary recall of one lot of ChloraPrep™ Clear 1 mL Applicators due to fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides

Published: Feb 18, 2025 | Category: FDA | Name: FDA Drugs

Artificial Intelligence for Drug Development

FDA recognizes the increased use of AI throughout the drug development process and across a range of therapeutic areas. Learn more.

Published: Feb 18, 2025 | Category: FDA | Name: FDA Drugs

Zenzi Pharmaceutical Industries Pvt. Ltd. - 701130 - 02/13/2025

Refusal to Provide Access to and Copying of Records

Published: Feb 18, 2025 | Category: FDA | Name: FDA Drugs

About BeSafeRx

“FDA’s BeSafeRx: Your Source for Online Pharmacy Information” is a national campaign to educate consumers and health care professionals about the potential dangers of buying medicine from unsafe websites that appear to be pharmacies.

Published: Feb 18, 2025 | Category: FDA | Name: FDA Drugs

ABR Laboratory LLC - 696872 - 02/10/2025

CGMP/Finished Pharmaceutical/Adulterated

Published: Feb 18, 2025 | Category: FDA | Name: FDA Drugs

AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp - 698782 - 01/29/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Feb 18, 2025 | Category: FDA | Name: FDA Drugs

Tyche Industries Ltd - 693081 - 02/06/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Feb 18, 2025 | Category: FDA | Name: FDA Drugs

Jagsonpal Pharmaceuticals Limited - 693134 - 02/05/2025

CGMP/Finished Pharmaceutical/Adulterated

Published: Feb 18, 2025 | Category: FDA | Name: FDA Drugs

Marshalls Traditional Healthcare CC - 697697 - 02/10/2025

CGMP/Finished Pharmaceutical/Adulterated

Published: Feb 18, 2025 | Category: FDA | Name: FDA Drugs

Vaccines Licensed for Use in the United States

The product name and trade name of vaccines licensed for use in the United States.

Published: Feb 14, 2025 | Category: FDA | Name: FDA Biologics

NDA and BLA Calendar Year Approvals

Published: Feb 14, 2025 | Category: FDA | Name: FDA Drugs

Efficacy Supplement Approvals

Published: Feb 14, 2025 | Category: FDA | Name: FDA Drugs

Cellular, Tissue, and Gene Therapies Advisory Committee November 21, 2024 Meeting Announcement - 11/21/2024

This is the main page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) November 21, 2024 announcement and meeting materials.

Published: Feb 14, 2025 | Category: FDA | Name: FDA Biologics

FDA approves vimseltinib for symptomatic tenosynovial giant cell tumor

On February 14, 2025, the Food and Drug Administration approved vimseltinib (Romvimza, Deciphera Pharmaceuticals, LLC), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or

Published: Feb 14, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes

FDA approved the first rapid-acting biosimilar insulin product, Merilog (insulin-aspart-szij), a biosimilar to its reference product Novolog (insulin aspart), to improve glycemic control in adults and children with diabetes mellitus.

Published: Feb 14, 2025 | Category: FDA | Name: FDA Press Release

Ivermectin and COVID-19

There continues to be interest in a drug called ivermectin for the prevention or treatment of COVID-19 in humans. The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals.

Published: Feb 14, 2025 | Category: FDA | Name: FDA Drugs

Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses

Sun safety is always in season. It’s important to protect your skin from sun damage throughout the year, no matter the weather. The FDA continues to evaluate sunscreen products to ensure that their active ingredients are safe and effective.

Published: Feb 14, 2025 | Category: FDA | Name: FDA Drugs

ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling

ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM CHLORIDE Inj. bags with overwrap labels 10mEq, packaged in cases of POTASSIUM CHLORIDE Inj. 20 mEq, to the user level. ICU medical has received a customer complaint which states that bags of POTASSIUM CHLORIDE Inj. 20 mEq have inco

Published: Feb 14, 2025 | Category: FDA | Name: FDA Drugs

10 Facts about What FDA Does and Does Not Approve

Is It Really "FDA Approved"? Maybe you’ve seen these words on a company’s website or in a commercial promoting a product or treatment. Here are some facts about products that are, and aren’t, FDA approved.

Published: Feb 14, 2025 | Category: FDA | Name: FDA Drugs

Drug Alerts and Statements

FDA Drug Alerts and Statements

Published: Feb 14, 2025 | Category: FDA | Name: FDA Drugs

FDA qualifies drug development tool to facilitate clinical trial research on alcohol use disorder

Published: Feb 14, 2025 | Category: FDA | Name: FDA Drugs

Individual Case Safety Reports

This web page is dedicated to the health and regulatory data standard: Individual Case Safety Report

Published: Feb 14, 2025 | Category: FDA | Name: FDA Drugs

Compounding Quality Center of Excellence | Instructor-Led Trainings

The Compounding Quality Center of Excellence’s free in-person training programs target outsourcing facility staff and offer continuing education credits. The training will open for state regulators and pharmacy compounders if space is available.

Published: Feb 13, 2025 | Category: FDA | Name: FDA Drugs

Drug Compliance Programs

FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area.

Published: Feb 13, 2025 | Category: FDA | Name: FDA Drugs

Know Which Medication Is Right for Your Seasonal Allergies

The pollen count is sky-high. You’re sneezing, your eyes are itching, and you feel miserable. Seasonal allergies are real diseases that can interfere with your life. The FDA regulates prescription and nonprescription medications that offer allergy relief.

Published: Feb 13, 2025 | Category: FDA | Name: FDA Drugs

Ticks and Lyme Disease: Symptoms, Treatment, and Prevention

Lyme disease is on the rise. How can you prevent it? What are the symptoms, and what should you do if you think you or your pet have it?

Published: Feb 13, 2025 | Category: FDA | Name: FDA Drugs

Should Your Child Participate in a Clinical Trial?

Clinical trials give us important information about the safety and effectiveness of a treatment. Before deciding whether your child should join a clinical trial, learn as much as you can, including the risks and benefits.

Published: Feb 13, 2025 | Category: FDA | Name: FDA Drugs

Should You Give Kids Medicine for Coughs and Colds?

Although most colds in children don’t cause serious complications, they can cause stress and worry in parents and caregivers. Most children will get better on their own, and cough or cold medicine will not change the natural course of a cold or make it go away faster.

Published: Feb 13, 2025 | Category: FDA | Name: FDA Drugs

POSTPONED: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

Published: Feb 13, 2025 | Category: FDA | Name: FDA Drugs

Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of Tydemy™ (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) Due to Out of Specification (OOS) Results

Lupin Pharmaceuticals Inc. (Lupin) is voluntarily recalling two (2) lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the patient (consumer/user) level due to out of specification (OOS) test results at t

Published: Feb 13, 2025 | Category: FDA | Name: FDA Drugs

Know Your Treatment Options for COVID-19

Patients today have several treatment options to prevent hospitalization and other serious complications of COVID-19. The FDA has approved drug treatments for COVID-19 and has authorized others for emergency use.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

eCTD Submission Standards for eCTD v3.2.2 and Regional M1

eCTD Submission Standards

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Cefepime – Injection products

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Azithromycin - Oral, Injection products

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Ceftazidime – Injection products

Ceftazidime – Injection products; Exceptions to the recognized standard of CLSI M100

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Cefuroxime - Injection products

Cefuroxime - Injection products; Exception to the recognized standard of CLSI M100

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Levofloxacin Oral, Injection products

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Meropenem - Injection products

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Minocycline Oral, Injection products

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Moxifloxacin Oral, Injection Products

Moxifloxacin Oral, Injection products: Additional FDA-identified interpretive criteria

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Tetracycline – Oral products

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Ticarcillin Clavulanate – Injection products

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Trimethoprim Sulfamethoxazole – Oral, Injection products

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

FDA Rationale for Breakpoints Recognition Decision: Polymyxins and Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter spp.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Ceftriaxone - Injection products

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Notices of Updates

Webpage providing notices of updates to FDA's STIC webpages for antibacterial and antifungal drugs.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

CBER’s Research Scientists

CBER’s Research Projects and Offices information

Published: Feb 12, 2025 | Category: FDA | Name: FDA Biologics

Create and Keep a Medication List for Your Health

Keeping track of when, how and why you use medications is important for your health and safety. A medication list helps you track all the prescription medications, over-the-counter (OTC) drugs, vitamins and supplements that you take. The list can be a lifesaver, especially during an emergency.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Biologics

Massachusetts Institute of Technology MIT - 663218 - 01/28/2025

Bioresearch Monitoring Program/IRB

Published: Feb 12, 2025 | Category: FDA | Name: FDA Biologics

Massachusetts Institute of Technology MIT - 663218 - 06/21/2024

Bioresearch Monitoring Program/IRB

Published: Feb 12, 2025 | Category: FDA | Name: FDA Biologics

Animal Welfare, Testing and Research of FDA-Regulated Products

FDA-regulated medical and veterinary products save lives. Products undergo different types of testing, including animal testing, to determine their safety and effectiveness. The FDA encourages and accepts scientifically valid alternatives to animal testing.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Biologics

Frontier Biologics, LLC - 686059 - 11/01/2024

Unapproved New Drug/Unlicensed Biological Product Violations

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

FDA Continues Important Work to Advance Medical Products for Patients with Rare Diseases

The goal of this year’s Rare Disease Day is to explore ways to engage and collaborate with patients and patient advocates to support the development of medical products for rare diseases.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Collaboration and Scientific Innovation Stimulated Advancement in the Generic Drug Program in 2022

In 2022, FDA had a very productive year with the approval of hundreds of generic drugs.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

FDA and FTC Collaborate to Advance Competition in the Biologic Marketplace

FDA and FTC have been working together to help advance competition for biologics, including biosimilars and interchangeable biosimilars.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing

AI/ML can help bring safe, effective, and high-quality treatments to patients faster. This post highlights the discussion papers, “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products," and "Artificial Intelligence in Drug Manufacturing."

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Lessons Learned from COVID-19 Are Informing Preparation for Future Public Health Emergencies

While the HHS public health emergency is ending, COVID-19 remains a high priority and the U.S. Food and Drug Administration will remain engaged with numerous activities to protect and promote public health.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Facilitating Review of Real-World Data Studies: The Oncology QCARD Initiative

The Oncology QCARD Initiative was designed to facilitate effective communication between study sponsors and protocol reviewers by evaluating the potential minimum elements for sponsors to consider when assembling submissions for review of a proposed study and RWD source(s).

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

What’s New for Biologics

Latest news from the Center for Biologics Evaluation and Research

Published: Feb 12, 2025 | Category: FDA | Name: FDA Biologics

An Update on FDA’s Overdose Prevention Framework - Addressing Critical Areas of Need

An update on activities FDA is taking across the agency in each of the Overdose Prevention Framework priorities.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

FDA’s IT Strategy: Unlocking Potential, Leading Transformation

FDA has released its comprehensive FDA Information Technology Strategy for Fiscal Years 2024 to 2027 (IT Strategy), marking a defining roadmap for the agency's technological advancement and the alignment with its broader public health mission.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Thoughts on Singapore, and FDA’s Ongoing Work to Improve Public Health

Our trip to Singapore offered us an opportunity to think about the FDA’s global presence, strengthen ties with an FDA strategic partner, and discuss opportunities and challenges in applying technological innovation around the world.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Competitive Generic Therapy Approvals

Explore the FDA’s Competitive Generic Therapy Approvals page, offering insights into the program designed to encourage generic drug competition. Access information about approved CGT products and find resources, including a downloadable CGT approvals spreadsheet.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

VAERS: A Critical Part of the National Vaccine Safety System

Monitoring vaccine safety is an important responsibility shared by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA).

Published: Feb 12, 2025 | Category: FDA | Name: FDA Biologics

FDA Protects Patients from Harmful Drugs Through the Drug Supply Chain Security Act

The FDA has been working to implement the DSCSA since it became law, and the 10-year anniversary is a good time to recognize our work with industry and other stakeholders thus far and the initiatives in store for the future.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Increasing Options in Clinical Research to Facilitate Medical Product Development

FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of people participating in clinical research.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Realizing the Promise of Real-World Evidence

Realizing the full potential of RWE in regulatory decision-making presents several challenges, and work is underway at the FDA to better understand this area.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma

On February 11, 2025, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma.

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

Study of Sex Differences in the Clinical Evaluation of Medical Products

This guidance provides recommendations for increasing enrollment of females in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific information in regulatory submissions of medical products

Published: Feb 12, 2025 | Category: FDA | Name: FDA Drugs

CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

Questions and Answers on Current Good Manufacturing Practices for Drugs

As part of the Current Good Manufacturing Practices (CGMP) initiative announced in August of 2002, and to help FDA be more transparent with CGMP policy, we have developed this question and answer resource on current good manufacturing practices.

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

Search for Regulatory References | Drugs

Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

Drug Quality Sampling and Testing Programs

FDA CDER's quality sampling and testing programs assess pharmaceutical quality after drugs are on the market.

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection

On February 11, 2025, the Food and Drug Administration approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

Drugs@FDA Data Files

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19

CDER Scientific Reviews Supporting EUA for Therapeutic Products

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

Drug Shortages | Additional News and Information

Drug Shortages: Additional News and Information

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

Americo F. Padilla, M.D. - 700447 - 01/17/2025

Clinical Investigator

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

Radioactive Drug Research Committee (RDRC) Program

Regulating the use of radioactive drugs in basic research

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

Designating an Orphan Product: Drugs and Biological Products

The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor.

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

ISOThrive, Inc. - 688547 - 02/04/2025

Clinical Investigator

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

Chengdu Innovation Pharmaceutical Co., Ltd. - 698786 - 02/05/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

Wuhu Nuowei Chemistry Co., Ltd. - 697727 - 02/04/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

Strukmyer LLC dba Strukmyer Medical - 692686 - 01/30/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Feb 11, 2025 | Category: FDA | Name: FDA Drugs

Model-Informed Drug Development Paired Meeting Program

FDA is conducting a MIDD Pilot Program to facilitate the development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources, referred to as MIDD approaches.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Drugs

MIDD Paired Meeting Program Frequently Asked Questions

MIDD Pilot Program Frequently Asked Questions (FAQs)

Published: Feb 10, 2025 | Category: FDA | Name: FDA Drugs

CDERLearn

Training and Education for healthcare professionals, academia, and consumers from FDA’s Center for Drug Evaluation and Research

Published: Feb 10, 2025 | Category: FDA | Name: FDA Drugs

Harnessing the Potential of Artificial Intelligence

At the FDA, we’ve been working for years to anticipate and prepare for the challenges of Artificial Intelligence (AI), and also to harness its potential.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Drugs

Over-The-Counter Monograph Drug User Fee Program (OMUFA)

A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Drugs

Completed BsUFA III Deliverables

Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review of biosimilar products.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Drugs

Vaccines, Blood & Biologics

From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Biologics

Reflections on Travel to Europe – Part Two

I recently had the privilege of official travel to the U.K. with our global affairs team.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Drugs

Medical Imaging Drugs Advisory Committee Roster

This page contains the Medical Imaging Drugs Advisory Committee roster, which lists the current members and the current number of vacancies for the committee.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Drugs

Dermal Filler Do's and Don'ts for Wrinkles, Lips and More

Check out the FDA's tips to safely use dermal fillers and learn the difference between dermal fillers and injectable botulinum toxin products.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Drugs

Other Fraudulent Products

A list of other fraudulent products in which FDA testing found active drug ingredients not listed on the product labels.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Drugs

Tainted Sexual Enhancement and Energy Products

FDA is notifying consumers of certain products promoted for sexual enhancement and energy have been found to contain hidden ingredients and may pose a significant health risk.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Drugs

Tainted Arthritis | Pain Products

FDA is notifying consumers of certain products promoted for arthritis and pain management that have been found to contain hidden ingredients and may pose a significant health risk.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Drugs

VITALITY may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use VITALITY, a product promoted and sold for sexual enhancement on https://www.zen-herbs.com and possibly in some retail stores.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Drugs

Special Edition Platinum 10K contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Special Edition Platinum 10K, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Drugs

bio LIT may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use bio LIT, a product promoted and sold for cognitive enhancements on various websites and possibly in some retail stores.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Drugs

vROX may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use vROX, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Drugs

From Awareness to Action: Tackling the Rising Burden of Common Chronic Diseases

One of the most alarming changes is the recent decline in life expectancy in our country, largely due to the cumulative impact of common chronic diseases.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Biologics

The Concerning Trend in Men’s Health

Despite spending more on healthcare than any other nation on earth, life expectancy in the U.S. is trending downward.

Published: Feb 10, 2025 | Category: FDA | Name: FDA Biologics

Description of FDA Forms for Export Certification

Published: Feb 7, 2025 | Category: FDA | Name: FDA Biologics

GDUFA Type II API DMF Payment Receipts Report

Published: Feb 7, 2025 | Category: FDA | Name: FDA Drugs

October 29, 2024: Meeting of the Pharmacy Compounding Advisory Committee - 10/29/2024

This meeting is scheduled to start at approximately 8 a.m. Eastern Time and will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room.

Published: Feb 7, 2025 | Category: FDA | Name: FDA Drugs

Roster of the Vaccines and Related Biological Products Advisory Committee

This is the Roster of the Vaccines and Related Biological Products Advisory Committee

Published: Feb 7, 2025 | Category: FDA | Name: FDA Biologics

International Engagements to Respond to Covid-19 Pandemic

Published: Feb 7, 2025 | Category: FDA | Name: FDA Biologics

Foreign Regulator Information Exchanges

In support of this mission element, the FDA’s Center for Biologics Evaluation and Research (CBER) exchanges critical regulatory information on an on-going basis with foreign regulatory counterparts using a range of mechanisms. CBER undertakes information exchanges with counterparts in the Americas,

Published: Feb 7, 2025 | Category: FDA | Name: FDA Biologics

Foreign Regulators – Information and Training Resources

FDA’s Office of International Programs (OIP) coordinates and facilitates the Agency’s Capacity Building Program which includes technical cooperation and assistance efforts. CBER partners with OIP in many of those activities, but also leads the effort in regulatory capacity building for regulated pro

Published: Feb 7, 2025 | Category: FDA | Name: FDA Biologics

International Activities

CBER’s international activities can be categorized in the following functional areas: regulatory harmonization, regulatory capacity building, information sharing, international standards setting, and collaborative research.

Published: Feb 7, 2025 | Category: FDA | Name: FDA Biologics

Aztreonam and Avibactam Injection

Published: Feb 7, 2025 | Category: FDA | Name: FDA Drugs

Notice of Updates

Webpage providing notices of updates to FDA's STIC webpages for antibacterial and antifungal drugs.

Published: Feb 7, 2025 | Category: FDA | Name: FDA Drugs

Antibacterial Susceptibility Test Interpretive Criteria

Published: Feb 7, 2025 | Category: FDA | Name: FDA Drugs

Outsmarting Poison Ivy and Other Poisonous Plants

Poison ivy, poison oak, and poison sumac are a hazard year-round. Here are tips for preventing and treating the itchy rash and blisters.

Published: Feb 7, 2025 | Category: FDA | Name: FDA Drugs

Public Meeting on the Recommendations for the Over-the-Counter Monograph Drug User Fee Program (OMUFA) Reauthorization - 11/20/2024 - 11/20/2024

The Food and Drug Administration (FDA or Agency) is announcing a hybrid public meeting to discuss proposed recommendations for the reauthorization of the Over-the-Counter Monograph Drug User Fee program (OMUFA) for fiscal years (FYs) 2026 through 2030. The virtual public meeting will be held on November 20, 2024, from 9 a.m. to 12:30 p.m. (ET).

Published: Feb 7, 2025 | Category: FDA | Name: FDA Drugs

Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020 to aid response efforts and ease the economic impact of COVID-19.

Published: Feb 7, 2025 | Category: FDA | Name: FDA Drugs

E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility

International Council on Harmonisation - Efficacy

Published: Feb 7, 2025 | Category: FDA | Name: FDA Drugs

Biologics Electronic Reading Room (eFOIA)

The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.

Published: Feb 6, 2025 | Category: FDA | Name: FDA Biologics

FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and pediatric patients with AML or MDS

On Jan. 21, 2025, the FDA approved treosulfan (Grafapex, medac GmbH) with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with acute myeloid leukemia or myelodysplastic syndrome.

Published: Feb 6, 2025 | Category: FDA | Name: FDA Drugs

Oncology (Cancer)/Hematologic Malignancies Approval Notifications

FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.

Published: Feb 6, 2025 | Category: FDA | Name: FDA Drugs

FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer

On January 27, 2025, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer.

Published: Feb 6, 2025 | Category: FDA | Name: FDA Drugs

Biosimilar Product Information

This page includes a chart of the approved biosimilar and interchangeable products. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs.

Published: Feb 6, 2025 | Category: FDA | Name: FDA Drugs

CDER Nitrosamine Impurity Acceptable Intake Limits

Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs); Updated Information

Published: Feb 6, 2025 | Category: FDA | Name: FDA Drugs

Novel Drug Approvals for 2025

Innovative drugs often mean new treatment options for patients and advances in health care for the American public.

Published: Feb 6, 2025 | Category: FDA | Name: FDA Drugs

Novel Drug Approvals at FDA

Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process.

Published: Feb 6, 2025 | Category: FDA | Name: FDA Drugs

Orange Book Preface

Preface to Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) provides info on how the book came to be, relevant terms and codes, user responsibilities and more.

Published: Feb 6, 2025 | Category: FDA | Name: FDA Drugs

Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

Published: Feb 6, 2025 | Category: FDA | Name: FDA Biologics

Study Data Standards Resources

Published: Feb 6, 2025 | Category: FDA | Name: FDA Drugs

Hurricane Helene: Baxter's manufacturing recovery in North Carolina

Information and updates on CDER-regulated drug and biologic products

Published: Feb 5, 2025 | Category: FDA | Name: FDA Drugs

2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials - 10/11/2023

2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials

Published: Feb 5, 2025 | Category: FDA | Name: FDA Drugs

Registered Outsourcing Facilities

Discover FDA's comprehensive list of registered outsourcing facilities engaged in human drug compounding. Get the latest updates, compliance guidelines, and resources to ensure safe, high-quality compounded medications. Explore regulations and stay informed with verified facility details.

Published: Feb 5, 2025 | Category: FDA | Name: FDA Drugs

COVID-19 Vaccines for 2024-2025

The FDA has approved and authorized for emergency use updated COVID-19 vaccines (2024-2025 formula) that include a monovalent (single) component that corresponds to the omicron variant KP.2 strain of SARS-CoV-2.

Published: Feb 5, 2025 | Category: FDA | Name: FDA Biologics

Facts About COVID-19 Vaccines

Facts about COVID-19 vaccines, including ingredients, safety and more

Published: Feb 5, 2025 | Category: FDA | Name: FDA Biologics

Is It Really 'FDA Approved'?

The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.

Published: Feb 5, 2025 | Category: FDA | Name: FDA Drugs

Jobs in Oncology/Hematology

FDA's Office of Hematology Oncology Products is recruiting Medical Oncologists to serve in the dynamic, highly challenging, and innovative atmosphere of oncology drug development and research.

Published: Feb 5, 2025 | Category: FDA | Name: FDA Drugs

FDA Drug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women

Repeated or lengthy use of general anesthetic and sedation drugs in children younger than 3 years or in pregnant women during their third trimester may affect children's developing brains, especially for surgeries longer than 3 hours or if multiple procedures are required.

Published: Feb 5, 2025 | Category: FDA | Name: FDA Drugs

Drug Trials Snapshots

Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparent.

Published: Feb 5, 2025 | Category: FDA | Name: FDA Drugs

FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices

The FDA is alerting patients of a safety concern regarding diabetes devices that rely on a smartphone to deliver critical safety alerts. The FDA has received medical device reports in which users report these alerts are not being delivered or not being heard.

Published: Feb 5, 2025 | Category: FDA | Name: FDA Press Release

Institutional Review Boards Frequently Asked Questions

IRB Information Sheet - Frequently Asked Questions

Published: Feb 5, 2025 | Category: FDA | Name: FDA Drugs

Drugs

Consumer articles about over-the-counter and prescription drugs.

Published: Feb 5, 2025 | Category: FDA | Name: FDA Drugs

Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products

Published: Feb 5, 2025 | Category: FDA | Name: FDA Drugs

Tissue Agnostic Drug Development in Oncology

This guidance describes the development of tissue agnostic drugs, scientific considerations in determining when tissue agnostic oncology drug development may be appropriate, and, if appropriate, issues to be addressed during such development.

Published: Feb 5, 2025 | Category: FDA | Name: FDA Drugs

Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present

The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.

Published: Feb 5, 2025 | Category: FDA | Name: FDA Drugs

Institutional Review Board (IRB) Written Procedures

Guidance for institutions and IRBs on IRB written procedures

Published: Feb 5, 2025 | Category: FDA | Name: FDA Drugs

Evaluation of Sex Differences in Clinical Investigations

Evaluation of Sex Differences in Clinical Investigations - IRB Information Sheet

Published: Feb 5, 2025 | Category: FDA | Name: FDA Drugs

Generic Drug Facilities, Sites and Organization Lists

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

CDER Manual of Policies & Procedures | MAPP

CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures.

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

User Fee Lists

GDUFA User Fee Lists

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

Compounding: Inspections, Recalls, and other Actions

Human drug compounding; FDA inspections; compounding recalls

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

Regulation of the Blood Supply

Published: Feb 4, 2025 | Category: FDA | Name: FDA Biologics

Blood & Blood Products

CBER regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components. FDA has strengthened the safeguards that protect patients from unsuitable blood and blood products and has increased its oversight of t

Published: Feb 4, 2025 | Category: FDA | Name: FDA Biologics

Upcoming EL-PFDD Meetings

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format

Labeling

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

Quarterly Inactive Ingredient Database (IID) Change Log

Quarterly IID Change Log displays changes made since the previous quarterly IID publication.

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

Inactive Ingredients Database Download

Data updated through July 2024

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

E2F Development Safety Update Report

International Council on Harmonisation - Efficacy

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products

Clinical/Medical

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products

Draft Guidance for Industry: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

Environmental Assessment of Human Drug and Biologics Applications

Pharmaceutical Quality/CMC

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

Global Calcium Pvt. Limited - 692000 - 01/16/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

Fagron Compounding Services, LLC dba Fagron Sterile Service - 698861 - 12/19/2024

Compounding Pharmacy/Adulterated Drug Products

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

Shantou Kangjie Daily Chemical Industry Co., Ltd - 698223 - 01/28/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

Imperial Palace Commodity -Dongguan- Co., Ltd. - 692842 - 01/27/2025

CGMP/Finished Pharmaceuticals/Adulterated

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

BioStem Life Sciences - 673788 - 01/17/2025

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Published: Feb 4, 2025 | Category: FDA | Name: FDA Biologics

Center for Instrumental Analysis of China Pharmaceutical University - 696906 - 01/23/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

E4 Dose-Response Information to Support Drug Registration

International Council on Harmonisation - Efficacy

Published: Feb 4, 2025 | Category: FDA | Name: FDA Drugs

What's New Related to Drugs

Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals

International Council on Harmonisation - Safety

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers

International Council on Harmonisation - Efficacy

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention

Clinical / Medical

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products

Guidance for Industry

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions

Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND; Frequently Asked Questions

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products

Real World Data/Real World Evidence

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications

Clinical Pharmacology

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

Exploratory IND Studies

Guidance for Industry, Investigators, and Reviewers - Exploratory IND Studies, Investigational New Drug Applications

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

Exception from Informed Consent Requirements for Emergency Research

Informed Consent Exception for Emergency Research - Guidance

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)

International Council on Harmonisation - Efficacy

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application

Over-the-Counter

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format

Drug Labeling OND

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

International Council for Harmonisation - Efficacy Guidance

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

M10 Bioanalytical Method Validation and Study Sample Analysis

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

Contents of a Complete Submission for the Evaluation of Proprietary Names

Labeling

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

Section 8400: Marketing Applications

This is the SOPP Section 8400: Marketing Applications main page.

Published: Feb 3, 2025 | Category: FDA | Name: FDA Biologics

Collection of Race and Ethnicity Data in Clinical Trials

Guidance for Industry and FDA Staff - Collection of Race and Ethnicity Data in Clinical Trials

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

Clinical Decision Support Software

This guidance clarifies the scope of FDA’s oversight of clinical decision support software intended for health care professionals (HCPs) as devices.

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

Assessment of Abuse Potential of Drugs

Clinical/Medical

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

M4E(R2): The CTD – Efficacy

International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary)

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

Survey Methodologies to Assess REMS Goals That Relate to Knowledge

Published: Feb 3, 2025 | Category: FDA | Name: FDA Drugs

Volume Limits for Automated Collection of Source Plasma

The increased number of automated plasma collection devices with varying capacities for tailoring each collection to the specific donor has resulted in the existence of multiple Food and Drug & Administration (FDA) approved nomograms.

Published: Feb 3, 2025 | Category: FDA | Name: FDA Biologics

How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)

Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)., guidance, VAERS, vaccine, adverse event, reporting, CBER, Biologics

Published: Feb 3, 2025 | Category: FDA | Name: FDA Biologics

Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product

Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product, CBER, Biologics

Published: Feb 3, 2025 | Category: FDA | Name: FDA Biologics

Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications

This is the Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications, CBER, Biologics

Published: Feb 3, 2025 | Category: FDA | Name: FDA Biologics

Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001

This is the Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001.

Published: Feb 3, 2025 | Category: FDA | Name: FDA Biologics

Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)

Guidance for Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs), CBER, Biologics

Published: Feb 3, 2025 | Category: FDA | Name: FDA Biologics

Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials

Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, CBER, Biiologics

Published: Feb 3, 2025 | Category: FDA | Name: FDA Biologics

Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications

Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications, CBER, Biologics

Published: Feb 3, 2025 | Category: FDA | Name: FDA Biologics

Preclinical Assessment of Investigational Cellular and Gene Therapy Products

Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products, CBER, Biologics

Published: Feb 3, 2025 | Category: FDA | Name: FDA Biologics

Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271

Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271 Guidance for Industry, cber, biologics

Published: Feb 3, 2025 | Category: FDA | Name: FDA Biologics

eSubmitter Application History

History of all updates to the application software in reverse chronological order by version number

Published: Feb 1, 2025 | Category: FDA | Name: FDA Biologics

Data Standards for Drug and Biological Product Submissions Containing Real-World Data

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Patient Engagement Collaborative

The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Public Engagement Staff.

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Human Gene Therapy for Hemophilia

Human Gene Therapy for Hemophilia, Draft Guidance for Industry, CBER, biologics

Published: Jan 31, 2025 | Category: FDA | Name: FDA Biologics

S7A Safety Pharmacology Studies for Human Pharmaceuticals

International Council on Harmonisation - Safety

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

This is the Draft Guidance for Industry - Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Published: Jan 31, 2025 | Category: FDA | Name: FDA Biologics

Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

This is the Draft Guidance for Industry - Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Published: Jan 31, 2025 | Category: FDA | Name: FDA Biologics

Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling

Clinical Pharmacology

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

This is the Guidance for Industry - Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Published: Jan 31, 2025 | Category: FDA | Name: FDA Biologics

Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System

Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal s

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Patient-Focused Drug Development: Methods to Identify What Is Important to Patients

Procedural Guidance

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format

Guidance for Industry - Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format, Labeling

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment

Clinical / Antimicrobial

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)

Clinical/Medical

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Serological Reagents for the Laboratory Diagnosis of West Nile Virus - Class II Special Controls Guidance Document for Industry and FDA Staff

Developed as a special control to support the classification of the West Nile virus (WNV) serological reagents into class II (special controls).

Published: Jan 31, 2025 | Category: FDA | Name: FDA Biologics

Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

This is the Guidance for Industry Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

Published: Jan 31, 2025 | Category: FDA | Name: FDA Biologics

Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling

Clinical Pharmacology

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

It’s a Good Time to Get Your Flu Vaccine

Getting vaccinated in the fall can lower your chances of getting the flu. Haven’t had your flu shot yet? It’s not too late. Every flu season is different. Your best defense against the flu is to get a vaccine every year.

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Section 8200: Investigational New Drugs (INDs)

This is the SOPP Section 8200: Investigational New Drugs (INDs) main page.

Published: Jan 31, 2025 | Category: FDA | Name: FDA Biologics

Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment

Clinical / Medical

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

This is the ; Guidance for Industry - Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Published: Jan 31, 2025 | Category: FDA | Name: FDA Biologics

Recently Issued Guidance Documents

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Tissue Guidances

This page contains a listing of tissue related guidances.

Published: Jan 31, 2025 | Category: FDA | Name: FDA Biologics

Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

This is the Guidance for Industry - Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Published: Jan 31, 2025 | Category: FDA | Name: FDA Biologics

Premarketing Risk Assessment

Guidance for Industry - Premarketing Risk Assessment, Clinical/Medical

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets

Drug Safety

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Pregnant? Breastfeeding? FDA Aims to Improve Drug Information

The FDA is helping women know more about the effects of medicines during pregnancy and breastfeeding. Discuss treatment options with your health care professional if you are pregnant or breastfeeding.

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Optimizing Postapproval Safety Studies to Expand Data Generation on Medication Use in Pregnancy

Postapproval pregnancy safety studies (or studies that focus on medication use after approval) can help guide clinical practice and provide useful information for product labeling.

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

M4S: The CTD -- Safety

International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary)

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Research in Progress | Office of Prescription Drug Promotion (OPDP) Research

Research in Progress | Office of Prescription Drug Promotion Research

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

Research Pending Peer Review and Publication | Office of Prescription Drug Promotion (OPDP) Research

Published: Jan 31, 2025 | Category: FDA | Name: FDA Drugs

FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

The FDA approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic to treat moderate to severe acute pain in adults.

Published: Jan 30, 2025 | Category: FDA | Name: FDA Press Release

FDA Roundup: January 17, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Jan 17, 2025 | Category: FDA | Name: FDA Press Release

FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review

Today, the U.S. Food and Drug Administration authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review.

Published: Jan 16, 2025 | Category: FDA | Name: FDA Press Release

FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products

FDA issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products.

Published: Jan 15, 2025 | Category: FDA | Name: FDA Press Release

FDA Roundup: January 14, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Jan 14, 2025 | Category: FDA | Name: FDA Press Release

FDA Proposes Requiring At-a-Glance Nutrition Information on the Front of Packaged Foods

FDA announces a proposed rule requiring food manufacturers to display a front-of-package (FOP) nutrition label on most packaged foods. The proposed FOP nutrition label, referred to as the Nutrition Info box, would display nutrition information interpreting the saturated fat, sodium, and added sugars

Published: Jan 14, 2025 | Category: FDA | Name: FDA Press Release

FDA Roundup: January 10, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Jan 10, 2025 | Category: FDA | Name: FDA Press Release

FDA Roundup: January 7, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Jan 7, 2025 | Category: FDA | Name: FDA Press Release

FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials

The FDA issued draft guidance that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials evaluating investigational medical products and/or that are conducted or supported by the Department of Health and Human Services.

Published: Jan 6, 2025 | Category: FDA | Name: FDA Press Release

FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions

The FDA issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality.

Published: Jan 6, 2025 | Category: FDA | Name: FDA Press Release

FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices

Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle.

Published: Jan 6, 2025 | Category: FDA | Name: FDA Press Release

FDA Proposes Updated Recommendations to Help Improve Performance of Pulse Oximeters Across Skin Tones

The FDA published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters – important devices for patient care used to estimate the amount of oxygen carried in the blood – across the range of skin pigmentation.

Published: Jan 6, 2025 | Category: FDA | Name: FDA Press Release

FDA Roundup: January 3, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Jan 3, 2025 | Category: FDA | Name: FDA Press Release

FDA Roundup: December 27, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Published: Dec 27, 2024 | Category: FDA | Name: FDA Press Release

FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products

FDA announced a proposed rule to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetic products

Published: Dec 26, 2024 | Category: FDA | Name: FDA Press Release

FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes

FDA approved the first generic referencing Victoza (liraglutide injection) 18 mg/3 mL, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise.

Published: Dec 23, 2024 | Category: FDA | Name: FDA Press Release

FDA Approves First Medication for Obstructive Sleep Apnea

Today, the FDA approved the first medication for the treatment of moderate to severe obstructive sleep apnea in adults with obesity, to be used in combination with a reduced-calorie diet and increased physical activity.

Published: Dec 20, 2024 | Category: FDA | Name: FDA Press Release

No title

Published: Jan 1, 1970 | Category: FDA | Name: FDA Drugs

Minutes of the HMPC meeting 4-6 May 2026

Published: Jul 17, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Orphan designation: infliximab Treatment of Kawasaki disease, 20/05/2026 Positive

Published: Jul 17, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: allogeneic human induced pluripotent stem cell-derived photoreceptor precursor cells Treatment of non-syndromic inherited retinal dystrophies of the rod-dominant phenotype, 20/05/2026 Positive

Orphan designation: allogeneic human induced pluripotent stem cell-derived photoreceptor precursor cells Treatment of non-syndromic inherited retinal dystrophies of the rod-dominant phenotype, 20/05/2026 Positive

Published: Jul 17, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: allogeneic human Wharton's jelly-derived mesenchymal stem cells Treatment of Charcot-Marie-Tooth disease, 20/05/2026 Positive

Published: Jul 17, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: humanised IgG1 monoclonal antibody against delta-like ligand 3, octakis(thioether) with N-[6-(2-mercapto-5-pyrimidinyl)-1-oxo-5-hexyn-1-yl]-L-valyl-N6,N6-dipropyl-L-lysyl-N-[[3-[(7S)-7-ethyl-7,8,11,13-tetrahydro-7-hydroxy-8,11-dioxo-10

Orphan designation: humanised IgG1 monoclonal antibody against delta-like ligand 3, octakis(thioether) with N-[6-(2-mercapto-5-pyrimidinyl)-1-oxo-5-hexyn-1-yl]-L-valyl-N6,N6-dipropyl-L-lysyl-N-[[3-[(7S)-7-ethyl-7,8,11,13-tetrahydro-7-hydroxy-8,11-dioxo-10H-1,3-dioxolo[4,5-g]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-14-yl]propoxy]methyl]glycinamide Treatment of pulmonary neuroendocrine carcinoma, 20/05/2026 Positive

Published: Jul 17, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: peptide-oligonucleotide conjugate against CNOT3 mRNA Treatment of inherited retinal dystrophies due to mutation in the PRPF31 gene, 20/05/2026 Positive

Published: Jul 17, 2026 | Category: EMA | Name: EMA Orphan

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 July 2026

CVMP opinions on veterinary medicinal products The Committee adopted a positive opinion for a marketing authorisation for Bexatil for the reduction of hyperglycaemia in cats…

Published: Jul 17, 2026 | Category: EMA | Name: EMA News

Orphan designation: allogeneic peripheral blood mononuclear cells incubated in vitro with mitomycin C Treatment of in solid organ transplantation, 20/05/2026 Positive

Published: Jul 17, 2026 | Category: EMA | Name: EMA Orphan

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - July 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 17 July 2026, 10:00 (CEST) to 17 July 2026, 11:30 (CEST)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - July 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 17 July 2026, 10:00 (CEST) to 17 July 2026, 11:30 (CEST)

Published: Jul 17, 2026 | Category: EMA | Name: EMA Events

Questions and answers on Article 20 non-pharmacovigilance procedures

Published: Jul 16, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Questions and answers on Article 13 referral procedures

Published: Jul 16, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Questions and answers on Article 29(4) referral procedures

Published: Jul 16, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Questions and answers on Article 30 referral procedures

Published: Jul 15, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Questions and answers on Article 31 non-pharmacovigilance referrals

Published: Jul 15, 2026 | Category: EMA | Name: EMA Procedural Guidelines

EMA and EISMEA boost cooperation to accelerate health innovations

EMA and the European Innovation Council and SMEs Executive Agency (EISMEA) have strengthened their cooperation in support of health innovation in the European Union (EU). Today…, Enabling innovation is central to our public health mission to bring new treatments to patients. Our collaboration with EISMEA helps us better support innovators to…, The earlier health innovators can engage with regulatory expertise, the better equipped they are to make informed development decisions, reduce risk and achieve our…, EMA and EISMEA will continue to work together on horizon scanning and regulatory readiness for new and disruptive health innovations. They will support EIC-funded projects and…

Published: Jul 15, 2026 | Category: EMA | Name: EMA News

Draft reflection paper on particulars for safety signals for (traditional) herbal medicinal products

Published: Jul 15, 2026 | Category: EMA | Name: EMA Public Consultations

Executive Director Emer Cooke's speech at the European Parliament's Committee on Public Health

Brussels, 14 July 2026Check against deliveryDear Ms Jerkovic, dear honourable members, thank you for the invitation today and for this opportunity to report on EMA’s…

Published: Jul 15, 2026 | Category: EMA | Name: EMA News

Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation - Corrigendum

Published: Jul 15, 2026 | Category: EMA | Name: EMA Scientific Guidelines

Industry webinar on new electronic application form (eAF) version, Online, from 22 July 2026, 14:00 (CEST) to 22 July 2026, 16:00 (CEST)

Published: Jul 14, 2026 | Category: EMA | Name: EMA Events

Agenda of the CVMP meeting 14-16 July 2026

Published: Jul 14, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the COMP Meeting 14-16 July 2026

Published: Jul 14, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Semaglutide and FlexTouch solution for injection in pre-filled pen product-specific bioequivalence guidance - various strengths

Published: Jul 14, 2026 | Category: EMA | Name: EMA Public Consultations

Minutes of the COMP meeting 11-12 May 2026

Published: Jul 13, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Pre-notification check for type IB Variations

Published: Jul 13, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Agenda - EMA/HMA European platform for regulatory science research platform meeting

Published: Jul 13, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2026

PRAC agrees new safety information on desogestrel- and etonogestrel-containing contraceptives and Litfulo, a medicine to treat alopecia areata   Desogestrel- and etonogestrel-…, Agenda Agenda of the PRAC meeting 6-9 July 2026Draft Reference Number: EMA/PRAC/141965/2026…, PRAC statistics: July 2026 , PRAC statistics: July 2026 English (EN) (174.12 KB - PDF)First published: 10/07/2026 View , Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between…

Published: Jul 10, 2026 | Category: EMA | Name: EMA News

Minutes - Enpr-EMA Coordinating Group meeting, April 2026

Published: Jul 10, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - EnprEMA Coordinating Group meeting, April 2026

Published: Jul 10, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Enpr-EMA Coordinating Group meeting April 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 April 2026, 14:00 (CEST) to 8 April 2026, 15:00 (CEST)

Published: Jul 10, 2026 | Category: EMA | Name: EMA Events

Agenda - Sixteenth industry stakeholder platform on research and development support

Published: Jul 9, 2026 | Category: EMA | Name: EMA Agenda and Minutes

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course (Bucharest) - October 2026, Hotel Capital Plaza Bucharest, from 29 October 2026, 08:00 (CET) to 30 October 2026, 12:00 (CET)

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course (Bucharest) - October 2026, Hotel Capital Plaza Bucharest, from 29 October 2026, 08:00 (CET) to 30 October 2026, 12:00 (CET)

Published: Jul 8, 2026 | Category: EMA | Name: EMA Events

EMA risk management information day

Published: Jul 8, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Orphan designation: copper metabolism disorder Treatment of Wilson's disease, 20/05/2026 Positive

Published: Jul 8, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: alixorexton Treatment of narcolepsy, 20/05/2026 Positive

Published: Jul 8, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: allogeneic human induced pluripotent stem cell-derived photoreceptor precursor cells Treatment of syndromic inherited retinal dystrophies of the rod-dominant phenotype, 20/05/2026 Positive

Orphan designation: allogeneic human induced pluripotent stem cell-derived photoreceptor precursor cells Treatment of syndromic inherited retinal dystrophies of the rod-dominant phenotype, 20/05/2026 Positive

Published: Jul 8, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: (S)-N-(2-(2-Cyclopropylpyridin-4-yl)-4,5,6,7-tetrahydrobenzo[d]oxazol-4-yl)-1-methyl-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide Treatment of KCNT1-related epilepsy, 20/05/2026 Positive

Orphan designation: (S)-N-(2-(2-Cyclopropylpyridin-4-yl)-4,5,6,7-tetrahydrobenzo[d]oxazol-4-yl)-1-methyl-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide Treatment of KCNT1-related epilepsy, 20/05/2026 Positive

Published: Jul 8, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: antisense oligonucleotide against USH2A pre-mRNA Treatment of inherited retinal disease due to dysfunction in the USH2A gene, 20/05/2026 Positive

Published: Jul 8, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: quemliclustat Treatment of pancreatic cancer, 20/05/2026 Positive

Published: Jul 8, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: igermetostat maleate Treatment of peripheral T-cell lymphoma, 20/05/2026 Positive

Published: Jul 8, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: serabelisib Treatment of PIK3CA related overgrowth spectrum, 20/05/2026 Positive

Published: Jul 8, 2026 | Category: EMA | Name: EMA Orphan

EMA fast tracks review of a medicine for metastatic pancreatic cancer

EMA’s human medicines committee (CHMP) has started a phased review of data on daraxonrasib, a medicine intended for the treatment of metastatic pancreatic cancer. A phased…

Published: Jul 7, 2026 | Category: EMA | Name: EMA News

SPOR and XEVMPD status update webinar - Q3 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 July 2026, 10:00 (CEST) to 8 July 2026, 12:30 (CEST)

Published: Jul 7, 2026 | Category: EMA | Name: EMA Events

Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance system, Bucharest, Romania, from 26 October 2026 to 28 October 2026

Published: Jul 7, 2026 | Category: EMA | Name: EMA Events

Qualification of novel methodologies for medicinal product development: guidance to applicants

Published: Jul 7, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Agenda of the PRAC meeting 6-9 July 2026

Published: Jul 6, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the HMPC meeting 6-8 July 2026

Published: Jul 6, 2026 | Category: EMA | Name: EMA Agenda and Minutes

17th Industry Standing Group (ISG) meeting, Online, from 29 June 2026, 09:30 (CEST) to 29 June 2026, 13:10 (CEST)

Published: Jul 6, 2026 | Category: EMA | Name: EMA Events

Joint European Commission (EC) / European Medicines Agency (EMA) multi-stakeholder workshop on regulatory sandbox, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 21 September 2026, 13:30 (CEST) to 21 September 2026, 17:00 (

Joint European Commission (EC) / European Medicines Agency (EMA) multi-stakeholder workshop on regulatory sandbox, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 21 September 2026, 13:30 (CEST) to 21 September 2026, 17:00 (CEST)

Published: Jul 3, 2026 | Category: EMA | Name: EMA Events

Meeting of the HMA-EMA group focused on AI with industry stakeholders - June 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, 2 June 2026

Published: Jul 3, 2026 | Category: EMA | Name: EMA Events

EMA steps up efforts on medicines for women’s health

EMA is launching initiatives to better embed women’s health considerations in medicines development and regulation. Women live longer than men on average but spend more of their…, Advancing developments in women’s health is one of my personal priorities. This is an area where we are seeing strong momentum at EU and global level, and where EMA is…, EMA’s initiatives in this area will be discussed through a dedicated women’s health workshop on 28-29 September. The workshop, broadcast live, will take stock of current…

Published: Jul 2, 2026 | Category: EMA | Name: EMA News

Q&A clinic on Substance, Organisation, Referentials Management Services - April 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 14 April 2026, 11:00 (CEST) to 14 April 2026, 12:00 (CEST)

Q&A clinic on Substance, Organisation, Referentials Management Services - April 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 14 April 2026, 11:00 (CEST) to 14 April 2026, 12:00 (CEST)

Published: Jun 30, 2026 | Category: EMA | Name: EMA Events

Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - April 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 April 2026, 15:00 (CEST) to 16 April 2026, 16:00 (CEST)

Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - April 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 April 2026, 15:00 (CEST) to 16 April 2026, 16:00 (CEST)

Published: Jun 30, 2026 | Category: EMA | Name: EMA Events

Q&A clinic on Substance, Organisation, Referentials Management Services - May 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 May 2026, 11:00 (CEST) to 12 May 2026, 12:00 (CEST)

Q&A clinic on Substance, Organisation, Referentials Management Services - May 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 May 2026, 11:00 (CEST) to 12 May 2026, 12:00 (CEST)

Published: Jun 30, 2026 | Category: EMA | Name: EMA Events

Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - May 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 May 2026, 15:00 (CEST) to 12 May 2026, 16:00 (CEST)

Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - May 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 May 2026, 15:00 (CEST) to 12 May 2026, 16:00 (CEST)

Published: Jun 30, 2026 | Category: EMA | Name: EMA Events

Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - May 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 May 2026, 15:00 (CEST) to 13 May 2026, 16:00 (CEST)

Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - May 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 May 2026, 15:00 (CEST) to 13 May 2026, 16:00 (CEST)

Published: Jun 30, 2026 | Category: EMA | Name: EMA Events

Multistakeholder workshop on women’s health, European Medicines Agency, Amsterdam, the Netherlands, from 28 September 2026, 09:30 (CEST) to 29 September 2026, 17:30 (CEST)

Published: Jun 30, 2026 | Category: EMA | Name: EMA Events

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 12 May 2026, 09:30 (CEST) to 12 May 2026, 13:30 (CEST)

Published: Jun 29, 2026 | Category: EMA | Name: EMA Events

Concept paper on the revision of the guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease

Published: Jun 29, 2026 | Category: EMA | Name: EMA Public Consultations

Concept paper on the revision of the guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances (EMA/CVMP/IWP/251947/2021)

Published: Jun 26, 2026 | Category: EMA | Name: EMA Public Consultations

Concept paper on the revision of the guideline on data requirements for the replacement of established master seeds (MS) already used in authorised immunological veterinary medicinal products (IVMPs) by new MS of the same origin

Concept paper on the revision of the guideline on data requirements for the replacement of established master seeds (MS) already used in authorised immunological veterinary medicinal products (IVMPs) by new MS of the same origin

Published: Jun 26, 2026 | Category: EMA | Name: EMA Public Consultations

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2026

Six new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended six medicines for approval at its June 2026 meeting.The committee recommended…, CHMP statistics Key figures from the June 2026 CHMP meeting are represented in the graphic below. © European Medicines Agency , CHMP statistics:…, Positive recommendations on new medicines, Aujemflu Common name Influenza vaccine (surface antigen, inactivated, adjuvanted, prepared in cell culture) Marketing authorisation applicant Seqirus Netherlands…, Hopledo INN levodopa / carbidopa  Marketing authorisation applicant Zambon S.p.A. Therapeutic indication Treatment of adult patients with Parkinson’s…, Onswik INN insulin efsitora alfa  Marketing authorisation applicant Eli Lilly Nederland B.V. Therapeutic indication Treatment of type 2 diabetes…, Positive recommendations on new biosimilar medicines, Denosumab Ascend INN denosumab Marketing authorisation applicant Ascend GmbH Therapeutic indication Prevention of skeletal related events and treatment of…, Nylaspeg INN pegfilgrastim Marketing authorisation applicant Qilu Pharma Spain S.L. Therapeutic indication Reduction of neutropoenia in adults More…, Positive recommendation on re-examination of new medicine, Daybu INN trofinetide Marketing authorisation applicant Acadia Pharmaceuticals (Netherlands) B.V. Therapeutic indication Daybu is indicated for the treatment…, Negative recommendations on new medicines, Tacquell INN autologous melanoma-derived tumour infiltrating lymphocytes, ex vivo-expanded  Marketing authorisation applicant Netherlands Cancer Institute…, Yartemlea INN narsoplimab  Marketing authorisation applicant Omeros Ireland Limited Therapeutic indication Treatment of patients with haemopoietic stem…, Xervyteg INN allogeneic faecal microbiota, pooled  Marketing authorisation applicant MaaT PHARMA Therapeutic indication Treatment of adult patients with…, Positive recommendations on extensions of therapeutic indications , Datroway INN datopotamab deruxtecan  Marketing authorisation holder Daiichi Sankyo Europe GmbH More information Datroway : pending EC decision, Imvanex Common name smallpox and monkeypox vaccine (live modified vaccinia virus Ankara) Marketing authorisation holder Bavarian Nordic A/S More information…, Ixchiq Common name Chikungunya vaccine (live) Marketing authorisation holder Valneva Austria GmbH More information Ixchiq : pending EC decision, Jaypirca INN pirtobrutinib Marketing authorisation holder Eli Lilly Nederland B.V. More information Jaypirca : pending EC decision, Leqvio INN inclisiran Marketing authorisation holder Novartis Europharm Limited More information Leqvio : pending EC decision, MenQuadfi Common name Meningococcal Group A, C, W and Y conjugate vaccine   Marketing authorisation holder Sanofi Winthrop Industrie More information…, Opzelura Common name ruxolitinib  Marketing authorisation holder Incyte Biosciences Distribution B.V. More information Opzelura : pending EC decision, Rezolsta INN darunavir / cobicistat   Marketing authorisation holder Janssen Cilag International More information Rezolsta : pending EC decision, Rinvoq INN upadacitinib   Marketing authorisation holder AbbVie Deutschland GmbH & Co. KG More information Rinvoq : pending EC decision (VR-…, Stelara INN ustekinumab Marketing authorisation holder Janssen Cilag International More information Stelara : pending EC decision, Symtuza INN darunavir / cobicistat / emtricitabine / tenofovir alafenamide Marketing authorisation holder Janssen Cilag International More information…, Tecvayli INN teclistamab Marketing authorisation holder Janssen-Cilag International N.V. More information Tecvayli : pending EC decision, Start of referral procedure, Rifadin oral suspension and syrup and associated names INN rifampicin  More information Rifadin oral suspension and syrup and associated names : referral, Conclusion of referral procedure, Tavneos INN avacopan  More information Tavneos : referral News EMA recommends revoking marketing authorisation for Tavneos , Withdrawal of applications to change the marketing authorisation, BiResp Spiromax INN budesonide More information BiResp Spiromax: Withdrawal, DuoResp Spiromax INN avacopan  More information DuoResp Spiromax: Withdrawal, Other updates, Outcome of assessment on use of Mounjaro to reduce the risk of serious events affecting the heart and blood circulationReference Number: EMA/140483/2026…

Published: Jun 26, 2026 | Category: EMA | Name: EMA News

Workshop on advancing proof-of-concept data in paediatric oncology drug development , Online, European Medicines Agency, Amsterdam, the Netherlands, from 21 September 2026, 13:00 (CEST) to 21 September 2026, 16:00 (CEST)

Workshop on advancing proof-of-concept data in paediatric oncology drug development , Online, European Medicines Agency, Amsterdam, the Netherlands, from 21 September 2026, 13:00 (CEST) to 21 September 2026, 16:00 (CEST)

Published: Jun 25, 2026 | Category: EMA | Name: EMA Events

HMA/EMA multistakeholder AI and Data forum: Build trustworthy AI on strong data foundations, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 12 November 2026 to 13 November 2026

HMA/EMA multistakeholder AI and Data forum: Build trustworthy AI on strong data foundations, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 12 November 2026 to 13 November 2026

Published: Jun 25, 2026 | Category: EMA | Name: EMA Events

Guideline on the clinical evaluation of medicinal products for weight management - Addendum on weight control in children

Published: Jun 25, 2026 | Category: EMA | Name: EMA Public Consultations

Agenda - PDCO agenda of the 23-26 June 2026 meeting

Published: Jun 23, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Annex 22 expert workshop draft agenda: Day 1 - session with interested parties

Published: Jun 23, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Fifth European Medicines Agency and Nuclear Medicines Europe bilateral meeting, Online, 14 June 2024

Published: Jun 22, 2026 | Category: EMA | Name: EMA Events

Minutes - HMA-EMA joint Network Data Steering Group meeting - 21 May 2026

Published: Jun 22, 2026 | Category: EMA | Name: EMA Agenda and Minutes

ETF-stakeholders meeting on biodistribution of mRNA vaccines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 June 2026, 14:00 (CEST) to 26 June 2026, 17:00 (CEST)

Published: Jun 22, 2026 | Category: EMA | Name: EMA Events

Paediatric Committee (PDCO): 23-26 June 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 June 2026 to 26 June 2026

Published: Jun 22, 2026 | Category: EMA | Name: EMA Events

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 June 2026

CVMP opinions on veterinary medicinal productsThe Committee adopted a negative opinion for a marketing authorisation for Scovella (velagliflozin), a product classified as…

Published: Jun 19, 2026 | Category: EMA | Name: EMA News

Orphan designation: 1-Deoxygalactonojirimycin hydrochloride Treatment of Fabry disease, 22/05/2006 Expired

Published: Jun 18, 2026 | Category: EMA | Name: EMA Orphan

Committee for Advanced Therapies (CAT): 17-19 June 2026, European Medicines Agency, Amsterdam, the Netherlands, from 17 June 2026 to 19 June 2026

Published: Jun 17, 2026 | Category: EMA | Name: EMA Events

Sixteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 15 June 2026, 13:00 (CEST) to 15 June 2026, 18:00 (CEST)

Sixteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 15 June 2026, 13:00 (CEST) to 15 June 2026, 18:00 (CEST)

Published: Jun 16, 2026 | Category: EMA | Name: EMA Events

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - May 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 May 2026, 10:00 (CEST) to 20 May 2026, 12:00 (CEST)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - May 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 May 2026, 10:00 (CEST) to 20 May 2026, 12:00 (CEST)

Published: Jun 16, 2026 | Category: EMA | Name: EMA Events

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, European Medicines Agency, Amsterdam, the Netherlands, from 16 June 2026, 10:00 (CEST) to 17 June 2026, 16:00 (CEST)

Published: Jun 16, 2026 | Category: EMA | Name: EMA Events

First Advisory group on vaccine confidence meeting, European Medicines Agency, Amsterdam, the Netherlands, from 29 April 2026, 16:30 (CEST) to 29 April 2026, 18:00 (CEST)

Published: Jun 16, 2026 | Category: EMA | Name: EMA Events

Committee for Advanced Therapies (CAT) rules of procedure

Published: Jun 16, 2026 | Category: EMA | Name: EMA Procedural Guidelines

EMA Management Board: highlights of June 2026 meeting

Crisis preparedness and responseThe Management Board welcomed EMA’s support to African regulators in the context of the Ebola outbreak in the Democratic Republic of Congo and…

Published: Jun 15, 2026 | Category: EMA | Name: EMA News

Regulatory Perspectives on Herbal Medicinal / Botanical Drug Product Development: Joint FDA / EMA Workshop, Online, European Medicines Agency, Amsterdam, the Netherlands, from 25 September 2026, 10:00 (CEST) to 25 September 2026, 13:00 (CEST)

Regulatory Perspectives on Herbal Medicinal / Botanical Drug Product Development: Joint FDA / EMA Workshop, Online, European Medicines Agency, Amsterdam, the Netherlands, from 25 September 2026, 10:00 (CEST) to 25 September 2026, 13:00 (CEST)

Published: Jun 12, 2026 | Category: EMA | Name: EMA Events

Regulatory Perspectives on Herbal Medicinal Botanical Drug Product Development - Joint FDA-EMA Workshop: Event agenda

Published: Jun 12, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2026

PRAC concludes evidence of potential risk of neurodevelopmental disorders in children born to men treated with valproate is inconsistent  Committee recommends updating product…, Agenda Agenda of the PRAC meeting 8-11 June 2026Draft Reference Number: EMA/PRAC/115322/2026…, PRAC statistics: June 2026 , , Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between…

Published: Jun 12, 2026 | Category: EMA | Name: EMA News

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – June 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 June 2026, 16:30 (CEST) to 12 June 2026, 17:30 (CEST)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – June 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 June 2026, 16:30 (CEST) to 12 June 2026, 17:30 (CEST)

Published: Jun 12, 2026 | Category: EMA | Name: EMA Events

Product Management Service (PMS) public API beta release - Technical overview and live demo, Online, from 13 July 2026, 14:00 (CEST) to 13 July 2026, 15:30 (CEST)

Published: Jun 12, 2026 | Category: EMA | Name: EMA Events

EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines

Today, EMA released its 2025 annual report, highlighting progress in bringing innovative, safe and effective medicines to patients. The report outlines the most important…

Published: Jun 11, 2026 | Category: EMA | Name: EMA News

Shortage prevention plan (SPP) workshop, Online, from 22 June 2026, 10:30 (CEST) to 22 June 2026, 12:30 (CEST)

Published: Jun 11, 2026 | Category: EMA | Name: EMA Events

Managing product data quality in PMS: processes, known issues, current status and best practices, Online, from 21 July 2026, 14:00 (CEST) to 21 July 2026, 15:30 (CEST)

Published: Jun 10, 2026 | Category: EMA | Name: EMA Events

Cancer Medicines Forum: March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, 2 March 2026

Published: Jun 10, 2026 | Category: EMA | Name: EMA Events

Sixteenth industry stakeholder platform on research and development support, European Medicines Agency, Amsterdam, the Netherlands, from 2 July 2026, 12:30 (CEST) to 2 July 2026, 17:30 (CEST)

Published: Jun 9, 2026 | Category: EMA | Name: EMA Events

EMA/HMA European platform for regulatory science research platform meeting – draft agenda

Published: Jun 9, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the PRAC meeting 8-11 June 2026

Published: Jun 8, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of PRAC meeting on 7-10 April 2026

Published: Jun 8, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - Clinical trials information system information day webinar

Published: Jun 5, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - Challenges in drug development, regulation and clinical practice in immune thrombocytopenia

Published: Jun 5, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Orphan designation: daratumumab Treatment of plasma-cell myeloma, 17/07/2013 Expired

Published: Jun 4, 2026 | Category: EMA | Name: EMA Orphan

PDCO minutes of the 21-24 April 2026 meeting

Published: Jun 3, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Concept paper on the development of a reflection paper on the use of External controls for evidence generation in regulatory decision-making

Published: Jun 3, 2026 | Category: EMA | Name: EMA Scientific Guidelines

EMA, AMA and African regulatory authorities join forces on Ebola outbreak response

EMA’s Emergency Task Force (ETF) is engaging with the African Medicines Agency (AMA) and its national regulatory authorities (NRAs), leveraging expertise from the WHO-AFRO…

Published: Jun 3, 2026 | Category: EMA | Name: EMA News

Meeting summary - Medicine shortages SPOC working party meeting 15 April 2026

Published: Jun 3, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Updates to industry contact management for authorisation products (IRIS), Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 June 2026, 11:00 (CEST) to 11 June 2026, 12:15 (CEST)

Published: Jun 3, 2026 | Category: EMA | Name: EMA Events

European platform for regulatory science research meeting: June 2026 , Online, from 16 June 2026, 14:00 (CEST) to 16 June 2026, 18:00 (CEST)

Published: Jun 2, 2026 | Category: EMA | Name: EMA Events

Minutes - HMA-EMA joint Network Data Steering Group meeting - 15 April 2026

Published: Jun 1, 2026 | Category: EMA | Name: EMA Agenda and Minutes

United for Health: EMA in WorldPride 2026

June is PRIDE month and EMA starts a two-month celebration of diversity and inclusion in science and healthcare, leading up to its participation in the world-famous Amsterdam…, Our strength in the EU comes from our unity in diversity. Equality and non-discrimination are critical everywhere, but in health they can make the difference between…, EMA staff will be joined on the boat by representatives of patient organisations such as EURORDIS-Rare Diseases Europe, European AIDS Treatment Group (EATG) and the European…

Published: May 31, 2026 | Category: EMA | Name: EMA News

SME info day - navigating EMA support: From development to market authorisation, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 6 November 2026, 09:15 (CET) to 6 November 2026, 15:30 (CET)

SME info day - navigating EMA support: From development to market authorisation, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 6 November 2026, 09:15 (CET) to 6 November 2026, 15:30 (CET)

Published: May 29, 2026 | Category: EMA | Name: EMA Events

ETF recommends updating COVID-19 vaccines to target XFG variant

EMA’s Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant XFG for the 2026/2027 vaccination campaign.XFG is part of the…

Published: May 29, 2026 | Category: EMA | Name: EMA News

Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) multistakeholder workshop on real-world data collection in duchenne muscular dystrophy, Online, European Medicines Agency, Amsterdam, the Netherlands, from 25 September 2026, 09:00 (C

Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) multistakeholder workshop on real-world data collection in duchenne muscular dystrophy, Online, European Medicines Agency, Amsterdam, the Netherlands, from 25 September 2026, 09:00 (CEST) to 25 September 2026, 17:30 (CEST)

Published: May 29, 2026 | Category: EMA | Name: EMA Events

Concept paper on the need for revision of the guideline on the development of medicinal products for the treatment of smoking

Published: May 29, 2026 | Category: EMA | Name: EMA Public Consultations

Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 3

Published: May 28, 2026 | Category: EMA | Name: EMA Procedural Guidelines

European Medicines Agency (EMA) / European Chemicals Agency (ECHA) joint meeting with industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 9 June 2026, 09:00 (CEST) to 9 June 2026, 12:00 (CEST)

European Medicines Agency (EMA) / European Chemicals Agency (ECHA) joint meeting with industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 9 June 2026, 09:00 (CEST) to 9 June 2026, 12:00 (CEST)

Published: May 27, 2026 | Category: EMA | Name: EMA Events

Orphan designation: 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]-1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]-2-propen-1-one (futibatinib) Treatment of biliary tract cancer, 01/04/2019 Withdrawn

Orphan designation: 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]-1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]-2-propen-1-one (futibatinib) Treatment of biliary tract cancer, 01/04/2019 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: S)-3-((S)-2-(2-((2,6-difluorophenyl)amino)-2-oxoacetamido)propanamido)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid Treatment of primary sclerosing cholangitis, 16/10/2017 Withdrawn

Orphan designation: S)-3-((S)-2-(2-((2,6-difluorophenyl)amino)-2-oxoacetamido)propanamido)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid Treatment of primary sclerosing cholangitis, 16/10/2017 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Humanised monoclonal antibody against P-selectin (crizanlizumab) Treatment of sickle cell disease, 09/08/2012 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: N-(5-tert-Butylisoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-yl)ethoxy) imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea di-hydrochloride salt Treatment of acute myeloid leukaemia, 23/03/2009 Withdrawn

Orphan designation: N-(5-tert-Butylisoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-yl)ethoxy) imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea di-hydrochloride salt Treatment of acute myeloid leukaemia, 23/03/2009 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: 5-Methyl-pyridine-2-sulfonic acid{6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-2-[2-(1H-tetrazol-5-yl)-pyridin-4-yl]-pyrimidin-4-yl}-amide sodium salt Treatment of aneurysmal subarachnoid haemorrhage, 12/12/2003 Withdrawn

Orphan designation: 5-Methyl-pyridine-2-sulfonic acid{6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-2-[2-(1H-tetrazol-5-yl)-pyridin-4-yl]-pyrimidin-4-yl}-amide sodium salt Treatment of aneurysmal subarachnoid haemorrhage, 12/12/2003 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: oregovomab Treatment of ovarian cancer, 30/07/2002 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: zilucoplan Treatment of myasthenia gravis, 18/07/2022 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Amended Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU recommendations for the seasonal influenza vaccine composition for the season 2026/2027

Published: May 26, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Orphan designation: macitentan Treatment of idiopathic pulmonary fibrosis, 28/01/2010 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: macitentan Treatment of functional single ventricle congenital heart disease, 20/05/2021 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: macitentan Treatment of chronic thromboembolic pulmonary hypertension, 10/12/2021 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Mavoglurant Treatment of fragile X syndrome, 10/10/2012 Withdrawn

Orphan designation: Mavoglurant  Treatment of fragile X syndrome, 10/10/2012 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: humanised IgG2k Fc-modified bispecific monoclonal antibody against CD3 and BCMA Treatment of multiple myeloma, 19/07/2021 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: vutrisiran Treatment of Stargardt's disease, 10/08/2022 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: cedazuridine,decitabine Treatment of myelodysplastic syndromes, 16/08/2023 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: ovine anti-colchicine polyclonal antibody fragments Treatment of colchicine poisoning, 17/12/2010 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: genetically modified serotype 5/3 adenovirus coding for granulocyte-macrophage colony-stimulating factor Treatment of soft tissue sarcoma, 19/06/2013 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor Treatment of malignant mesothelioma, 16/12/2014 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Treatment of Alagille syndrome, 09/08/2012 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: macitentan Treatment of pulmonary arterial hypertension, 27/09/2011 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Human platelet antigen-1a immunoglobulin Prevention of fetal and neonatal alloimmune thrombocytopenia, 27/10/2011 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: sutimlimab Treatment of immune thrombocytopenia, 28/02/2020 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Copanlisib Treatment of marginal zone lymphoma, 24/08/2018 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: adeno-associated virus vector serotype hu37 encoding human factor VIII Treatment of haemophilia A, 22/04/2020 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor (lacnotuzumab) Treatment of tenosynovial giant cell tumour, localised and diffuse type, 15/10/2014 Withdrawn

Orphan designation: recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor (lacnotuzumab) Treatment of tenosynovial giant cell tumour, localised and diffuse type, 15/10/2014 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Dantrolene sodium Treatment of Wolfram syndrome, 12/12/2016 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: tislelizumab Treatment of nasopharyngeal cancer, 21/06/2021 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: vincristine sulfate liposomes Treatment of acute lymphoblastic leukaemia, 08/07/2008 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: antisense NF-kBp65 oligonucleotide Treatment of active ulcerative colitis, 30/07/2002 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: acetylsalicylic acid Treatment of polycythaemia vera, 29/07/2004 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: recombinant human factor IX protein modified with three point mutations (dalcinonacog alfa) Treatment of haemophilia B, 20/06/2017 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Marzeptacog alfa (activated) Treatment of haemophilia B, 01/04/2019 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Treatment of paroxysmal nocturnal haemoglobinuria, 19/02/2021 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: humanised fusion protein consisting of extracellular domain of CD24 linked to IgG1 Fc domain Prevention of graft-versus-host disease, 11/11/2015 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: recombinant monoclonal antibody to sialic acid-binding Ig-like lectin 8 Treatment of mastocytosis, 16/10/2017 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: anti-SIGLEC8 IgG1 humanised monoclonal antibody Treatment of eosinophilic gastroenteritis, 19/02/2021 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: 2-[3-(2-chloro-4-{[5-cyclopropyl-3-(2,6-dichlorophenyl)-1,2-oxazol-4-yl]methoxy}phenyl)-3-hydroxyazetidin-1-yl]pyridine-4-carboxylic acid-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1) Treatment of primary sclerosing cholangitis, 01/0

Orphan designation: 2-[3-(2-chloro-4-{[5-cyclopropyl-3-(2,6-dichlorophenyl)-1,2-oxazol-4-yl]methoxy}phenyl)-3-hydroxyazetidin-1-yl]pyridine-4-carboxylic acid-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1) Treatment of primary sclerosing cholangitis, 01/04/2019 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: sabatolimab Treatment of myelodysplastic syndromes, 20/08/2021 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Ilginatinib maleate Treatment of myelofibrosis, 25/07/2023 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene Treatment of glycogen storage disease type II (Pompe's disease), 16/04/2018 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: navitoclax Treatment of myelofibrosis, 16/12/2019 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: acalabrutinib Treatment of mantle cell lymphoma, 21/03/2016 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: pegylated adrenomedullin Treatment of acute respiratory distress syndrome (ARDS), 27/07/2020 Withdrawn

Published: May 26, 2026 | Category: EMA | Name: EMA Orphan

Second HMA/EMA multi-stakeholder forum on EudraVigilance and signal detection, Online, European Medicines Agency, Amsterdam, the Netherlands, 1 December 2026

Published: May 26, 2026 | Category: EMA | Name: EMA Events

Questions and answers on periodic safety update report single-assessment (PSUSA): Guidance document for assessors

Published: May 22, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note

Published: May 22, 2026 | Category: EMA | Name: EMA Scientific Guidelines

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 19-21 May 2026

CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion for a marketing authorisation for Nobivac NXT HC, for the active immunisation of …

Published: May 22, 2026 | Category: EMA | Name: EMA News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2026

Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its May 2026 meeting.Jascayd (nerandomilast)…, CHMP statistics Key figures from the May 2026 CHMP meeting are represented in the graphic below.  , CHMP statistics:…, Positive recommendations on new medicines, Boey INN trenibotulinumtoxinE Marketing authorisation applicant AbbVie Deutschland GmbH & Co Therapeutic indication Temporary improvement in the…, Etcamah INN camizestrant Marketing authorisation applicant Astra Zeneca Therapeutic indication Etcamah in combination with a CDK4/6 inhibitor (palbociclib,…, Jascayd INN nerandomilast  Marketing authorisation applicant Boehringer Ingelheim International GmbH  Therapeutic indication Treatment of adult…, Vijoice INN alpelisib  Marketing authorisation applicant Novartis Europharm Limited Therapeutic indication Vijoice is indicated for the treatment of…, Positive recommendations on new hybrid medicines, Ablymico INN liraglutide  Marketing authorisation applicant STADA Arzneimittel AG  Therapeutic indication Treatment of diabetes and weight…, Liraglutide STADA INN liraglutide  Marketing authorisation applicant STADA Arzneimittel AG  Therapeutic indication Treatment of adults, adolescents…, Colchicine AGEPHA Pharma INN colchicine  Marketing authorisation applicant Agepha Pharma s.r.o. Therapeutic indication Indicated to reduce the risk of…, Positive recommendations on new biosimilar medicine, Vislyfa INN ranibizumab  Marketing authorisation applicant Lupin Europe GmbH  Therapeutic indication The treatment of neovascular (wet) age-related…, Negative recommendations on new medicines, Deqtynet INN copper (64Cu) oxodotreotide  Marketing authorisation applicant Cis Bio International  Therapeutic indication For positron emission…, Positive recommendations on extensions of therapeutic indications , Braftovi INN encorafenib Marketing authorisation holder Pierre Fabre Medicament More information Braftovi : pending EC decision, Enhertu INN trastuzumab deruxtecan  Marketing authorisation holder Daiichi Sankyo Europe GmbH More information Enhertu: pending EC decision (EMA/VR/…, Erbitux INN cetuximab Marketing authorisation holder Merck Europe B.V.  More information Erbitux: pending EC decision (EMA/VR/0000326978)Erbitux:…, Fasenra INN benralizumab Marketing authorisation holder AstraZeneca AB More information Fasenra: pending EC decision, Hetronifly INN serplulimab  Marketing authorisation holder Accord Healthcare S.L.U. More information Hetronifly: pending EC decision, Iclusig INN ponatinib  Marketing authorisation holder Incyte Biosciences Distribution B.V. More information Iclusig: pending EC decision, Keytruda INN pembrolizumab  Marketing authorisation holder Merck Sharp & Dohme B.V. More information Keytruda: pending EC decision (EMA/VR/…, Maviret INN glecaprevir / pibrentasvir  Marketing authorisation holder AbbVie Deutschland GmbH & Co. KG More information Maivret : pending EC…, Padcev INN enfortumab vedotin  Marketing authorisation holder Astellas Pharma Europe B.V. More information Padcev : pending EC decision, Palynziq INN pegvaliase Marketing authorisation holder BioMarin International Limited More information Palynziq : pending EC decision, Sogroya INN somapacitan  Marketing authorisation holder Novo Nordisk A/S More information Sogroya : pending EC decision, Tepkinly INN epcoritamab Marketing authorisation holder AbbVie Deutschland GmbH & Co. KG More information Tepkinly : pending EC decision, Trodelvy INN sacituzumab govitecan  Marketing authorisation holder Gilead Sciences Ireland Unlimited Company More information Trodelvy : pending EC…, Withdrawal of initial marketing authorisation applications, Veblocema INN infliximab  Marketing authorisation holder Celltrion Healthcare Hungary Kft. More information Veblocema : questions and answers, Orblid INN bevacizumab  Marketing authorisation holder Laboratoires Delbert More information Orblid : questions and answers, Other updates, Wegovy INN semaglutide  Marketing authorisation holder Novo Nordisk A/S   More information Wegovy : pending EC decision (EMA/X/0000296344) News…, Overview of (invented) names reviewed in April 2026 by the Name Review Group (NRG) adopted at the…

Published: May 22, 2026 | Category: EMA | Name: EMA News

Orphan designation: bevacizumab Treatment of hereditary haemorrhagic telangiectasia, 16/12/2014 Positive

Published: May 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: alpelisib Treatment of PIK3CA related overgrowth spectrum, 26/03/2021 Positive

Published: May 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Copper (64Cu) oxodotreotide Diagnosis of neuroendocrine neoplasms, 09/12/2022 Positive

Published: May 22, 2026 | Category: EMA | Name: EMA Orphan

New medicine for two types of pulmonary fibrosis

EMA has recommended granting a marketing authorisation in the European Union (EU) for Jascayd (nerandomilast) to treat adults with idiopathic pulmonary fibrosis (IPF) or…

Published: May 22, 2026 | Category: EMA | Name: EMA News

EMA closed on Whit Monday, 25 May

EMA’s office is closed on 25 May, to mark Whit Monday. The office reopens 08:30 on Tuesday, 26 May.The product emergency hotline is available outside working hours and on…

Published: May 21, 2026 | Category: EMA | Name: EMA News

Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - November 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 November 2026, 14:00 (CET) to 26 November 2026, 18:00 (CET)

Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - November 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 November 2026, 14:00 (CET) to 26 November 2026, 18:00 (CET)

Published: May 21, 2026 | Category: EMA | Name: EMA Events

Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - October 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 October 2026, 09:00 (CEST) to 8 October 2026, 13:00 (CEST)

Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - October 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 October 2026, 09:00 (CEST) to 8 October 2026, 13:00 (CEST)

Published: May 21, 2026 | Category: EMA | Name: EMA Events

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, European Medicines Agency, Amsterdam, the Netherlands, from 14 September 2026 to 18 September 2026

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, European Medicines Agency, Amsterdam, the Netherlands, from 14 September 2026 to 18 September 2026

Published: May 20, 2026 | Category: EMA | Name: EMA Events

Webinar on new approach methodologies (NAMs) in ecotoxicology: In silico approaches for fish acute toxicity, Online, European Medicines Agency, Amsterdam, the Netherlands, from 28 May 2026, 14:00 (CEST) to 28 May 2026, 15:30 (CEST)

Webinar on new approach methodologies (NAMs) in ecotoxicology: In silico approaches for fish acute toxicity, Online, European Medicines Agency, Amsterdam, the Netherlands, from 28 May 2026, 14:00 (CEST) to 28 May 2026, 15:30 (CEST)

Published: May 20, 2026 | Category: EMA | Name: EMA Events

EU tracks progress towards 2030 clinical trial targets

The European Commission (EC), the Heads of Medicines Agencies (HMA) and EMA have published their first report tracking progress against the EU’s new clinical trial targets.…

Published: May 20, 2026 | Category: EMA | Name: EMA News

Agenda of the CVMP meeting 19-21 May 2026

Published: May 19, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Orphan designation: adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene Treatment of Duchenne muscular dystrophy, 29/08/2016 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

EMA risk management information day, European Medicines Agency, Amsterdam, the Netherlands, from 8 September 2026, 09:00 (CEST) to 8 September 2026, 17:00 (CEST)

Published: May 18, 2026 | Category: EMA | Name: EMA Events

Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 March 2026, 15:00 (CET) to 10 March 2026, 16:00 (C

Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 March 2026, 15:00 (CET) to 10 March 2026, 16:00 (CET)

Published: May 18, 2026 | Category: EMA | Name: EMA Events

Annex to agenda of the CHMP meeting 18-21 May 2026

Published: May 18, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the CHMP meeting 18-21 May 2026

Published: May 18, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Orphan designation: 4-[(3S)-3-aminopyrrolidin-1-yl]-6-cyano-5-(3,5-difluorophenyl)-N-[(2S)-1,1,1-trifluoropropan-2-yl]pyridine-3-carboxamide Treatment of congenital hyperinsulinism, 09/12/2020 Withdrawn

Orphan designation: 4-[(3S)-3-aminopyrrolidin-1-yl]-6-cyano-5-(3,5-difluorophenyl)-N-[(2S)-1,1,1-trifluoropropan-2-yl]pyridine-3-carboxamide Treatment of congenital hyperinsulinism, 09/12/2020 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Dexamethasone sodium phosphate encapsulated in human erythrocytes Treatment of cystic fibrosis, 20/10/2004 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Dexamethasone sodium phosphate encapsulated in human autologous erythrocytes Treatment of ataxia telangiectasia, 17/07/2013 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: tazemetostat Treatment of diffuse large B-cell lymphoma, 21/03/2018 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: tazemetostat Treatment of malignant mesothelioma, 21/03/2018 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: avenciguat Treatment of systemic sclerosis, 11/11/2024 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: ataluren Treatment of Becker muscular dystrophy, 04/07/2012 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: ataluren Treatment of aniridia, 09/10/2015 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: tipifarnib Treatment of peripheral T-cell lymphoma, 19/10/2020 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: tipifarnib Treatment of acute myeloid leukaemia, 10/03/2005 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: bemarituzumab Treatment of gastric cancer, 21/08/2024 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: 2-[4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino]-indan-2-carboxylic acid Treatment of systemic sclerosis, 12/03/2013 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: autologous adipose tissue-derived mesenchymal stem cells Treatment of thromboangiitis obliterans (Buerger's disease), 20/03/2017 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: nimorazole Treatment of squamous-cell carcinoma of the head and neck in patients undergoing radiotherapy, 23/02/2011 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: alpha-tocotrienol quinone Treatment of Leigh syndrome, 09/12/2011 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: (S)-1-(4-(1-(3,4,5-trimethoxyphenyl)-1H-imidazol-4-ylamino)thieno[2,3-d]pyrimidin-2-yl)pyrrolidine-2-carboxamide Treatment of fibrodysplasia ossificans progressiva, 18/07/2022 Withdrawn

Orphan designation: (S)-1-(4-(1-(3,4,5-trimethoxyphenyl)-1H-imidazol-4-ylamino)thieno[2,3-d]pyrimidin-2-yl)pyrrolidine-2-carboxamide Treatment of fibrodysplasia ossificans progressiva, 18/07/2022 Withdrawn

Published: May 18, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: vatiquinone Treatment of RARS2 syndrome, 17/01/2018 Withdrawn

Published: May 13, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: vatiquinone Treatment of Alpers-Huttenlocher syndrome, 10/12/2021 Withdrawn

Published: May 13, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: vatiquinone Treatment of mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes, 24/02/2022 Withdrawn

Published: May 13, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: perflubron Treatment of respiratory distress syndrome, 09/12/2020 Withdrawn

Published: May 13, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: C1 esterase inhibitor (human) Treatment in solid organ transplantation, 14/12/2018 Withdrawn

Published: May 13, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Treatment of sickle cell disease, 05/08/2013 Withdrawn

Published: May 13, 2026 | Category: EMA | Name: EMA Orphan

EMA actively monitoring cruise ship Hantavirus outbreak

EMA is actively monitoring the ongoing hantavirus outbreak linked to a cruise ship, in coordination with other EU bodies.The virus has been identified as Andes hantavirus, the…

Published: May 12, 2026 | Category: EMA | Name: EMA News

EMA business hours over Ascension Day holidays, 14 and 15 May

EMA's office is closed from 18:00 on 13 May 2026 until 08:30 on 18 May 2026.The product emergency hotline is available outside working hours and on public holidays. To reach…

Published: May 12, 2026 | Category: EMA | Name: EMA News

EMA welcomes political agreement on Critical Medicines Act

EMA welcomes the provisional agreement reached by the European Parliament and the Council of the European Union on the proposed Critical Medicines Act (CMA), which represents an…, “At a time of increasing global disruptions, resilient and secure supply chains for critical medicines are essential to protect public health across the EU. Today’s…, In recent years, EU Member States have faced serious medicine shortages and global challenges such as the COVID-19 pandemic and geopolitical tensions have exposed…

Published: May 12, 2026 | Category: EMA | Name: EMA News

Agenda of the CAT meeting 11-13 May 2026

Published: May 11, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Orphan designation: Adeno-associated viral vector serotype Anc80 containing the 3' portion of human OTOF gene, adeno-associated viral vector serotype Anc80 containing the 5' portion of human OTOF gene Treatment of otoferlin gene-mediated hearing loss, 19/

Orphan designation: Adeno-associated viral vector serotype Anc80 containing the 3' portion of human OTOF gene, adeno-associated viral vector serotype Anc80 containing the 5' portion of human OTOF gene Treatment of otoferlin gene-mediated hearing loss, 19/07/2021 Positive

Published: May 11, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: 2-((2-fluoro-4-iodophenyl)amino)-N-(2-hydroxyethoxy)-1-methyl-1H-pyrrolo[2,3-b]pyridine-3-carboxamide Treatment of neurofibromatosis type 1, 22/05/2023 Positive

Published: May 11, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: encaleret Treatment of hypoparathyroidism, 15/10/2021 Positive

Published: May 11, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: eltanexor Treatment of myelodysplastic syndromes, 21/06/2022 Positive

Published: May 11, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N'-(pyrazin-2-yl)acrylohydrazide Treatment of diffuse large B-cell lymphoma, 22/08/2014 Positive

Published: May 11, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: selinexor Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma, 19/11/2014 Positive

Published: May 11, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: selinexor Treatment of myelofibrosis, 11/10/2022 Positive

Published: May 11, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: selinexor Treatment of glioma, 15/10/2021 Positive

Published: May 11, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N'-(pyrazin-2-yl)acrylohydrazide Treatment of acute myeloid leukaemia, 22/08/2014 Positive

Published: May 11, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: pridopidine hydrochloride Treatment of amyotrophic lateral sclerosis, 19/07/2021 Positive

Published: May 11, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1 (pridopidine hydrochloride) Treatment of Huntington’s disease, 20/06/2005 Positive

Published: May 11, 2026 | Category: EMA | Name: EMA Orphan

Agenda of the COMP Meeting 11-12 May 2026

Published: May 11, 2026 | Category: EMA | Name: EMA Agenda and Minutes

PDCO minutes of the 24-27 March 2026 meeting

Published: May 8, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 May 2026

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines:…, Agenda Agenda of the PRAC meeting 4-7 May 2026Draft Reference Number…, PRAC statistics: May 2026 , PRAC statistics: May 2026 English (EN) (104.16 KB - PDF)First published:…, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between…

Published: May 8, 2026 | Category: EMA | Name: EMA News

Good manufacturing practice: Multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22), Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 June 2026, 09:00 (CEST) to 1 July 2026, 18:00

Good manufacturing practice: Multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22), Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 June 2026, 09:00 (CEST) to 1 July 2026, 18:00 (CEST)

Published: May 8, 2026 | Category: EMA | Name: EMA Events

EU recommendations for 2026/2027 seasonal flu vaccine composition

This news announcement was updated on 7 May 2026 to include additional recommendations for strains for seasonal egg-derived and live-attenuated influenza vaccinesEMA has issued…

Published: May 7, 2026 | Category: EMA | Name: EMA News

Clinical Trials Information System (CTIS): Information day, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 17 June 2026, 12:30 (CEST) to 17 June 2026, 17:30 (CEST)

Published: May 7, 2026 | Category: EMA | Name: EMA Events

Minutes of PRAC meeting on 9-12 March 2026

Published: May 6, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - EnprEMA & ACT EU workshop on paediatric clinical trials

Published: May 5, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the PRAC meeting 4-7 May 2026

Published: May 5, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CAT meeting 18-20 March 2026

Published: May 5, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the COMP meeting 17-18 March 2026

Published: May 5, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Meeting summary - Medicine Shortages SPOC Working Party meeting 16-17 March 2026

Published: May 4, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the Management Board meeting: 12 March 2026

Published: May 4, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes - Executive Steering Group on Shortages of Medical Devices (MDSSG) (23 March 2026)

Published: May 4, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Pharmacovigilance Risk Assessment Committee (PRAC): 4 - 7 May 2026, European Medicines Agency, Amsterdam, the Netherlands, from 4 May 2026 to 7 May 2026

Published: May 4, 2026 | Category: EMA | Name: EMA Events

Agenda of the COMP Meeting 14-16 April 2026

Published: May 4, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Notice to sponsors on validation and qualification of computerised systems used in clinical trials

Published: May 4, 2026 | Category: EMA | Name: EMA Procedural Guidelines

EMA and European Association of Nuclear Medicine (EANM) bilateral meeting, Online, from 20 April 2026, 16:00 (CEST) to 20 April 2026, 17:20 (CEST)

Published: Apr 30, 2026 | Category: EMA | Name: EMA Events

Annexes to ICH Q3C guideline on impurities: guideline for residual solvents (EMA/CHMP/ICH/82260/2006) and VICH GL18 Impurities: residual solvents in new veterinary medicinal products, active substances and excipients (EMA/CVMP/VICH/502/1999) - Revision 2

Annexes to ICH Q3C guideline on impurities: guideline for residual solvents (EMA/CHMP/ICH/82260/2006) and VICH GL18 Impurities: residual solvents in new veterinary medicinal products, active substances and excipients (EMA/CVMP/VICH/502/1999) - Revision 2

Published: Apr 29, 2026 | Category: EMA | Name: EMA Public Consultations

EMA launches new advisory group on vaccine confidence

EMA has set up a new advisory group on vaccine confidence, which will advise the Agency on issues related to vaccine hesitancy and help guide its actions to increase science…, "Vaccine hesitancy is a growing global threat to public health. When public trust declines, infectious diseases can reemerge, putting lives at risk. EMA has a vital…, The advisory group on vaccine confidence will meet quarterly. It includes academics, representatives of healthcare professionals, medical societies and patient organisations, as…

Published: Apr 29, 2026 | Category: EMA | Name: EMA News

Agenda - European Platform for Regulatory Science Research meeting

Published: Apr 28, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - European Medicines Regulatory Network workshop on Geographic Atrophy endpoints

Published: Apr 28, 2026 | Category: EMA | Name: EMA Agenda and Minutes

New pilot to support development of ‘breakthrough’ medical devices

EMA has launched a pilot programme to support the development of breakthrough medical devices in the European Union (EU). The purpose of the pilot is to test a new regulatory…

Published: Apr 28, 2026 | Category: EMA | Name: EMA News

Minutes - Executive steering group on shortages and safety of medicinal products (MSSG) - 23 March 2026

Published: Apr 24, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CVMP meeting 10-12 February 2026

Published: Apr 24, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2026

Five new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended five medicines for approval at its April 2026 meeting.The committee recommended…, CHMP statistics Key figures from the April 2026 CHMP meeting are represented in the graphic below. , CHMP statistics Key figures from the April 2026 CHMP meeting are represented in the graphic below…, Positive recommendations on new medicines, Cenrifki INN tolebrutinib Marketing authorisation applicant Sanofi Winthrop Industrie Therapeutic indication Treatment of non-relapsing secondary progressive…, Itvisma INN onasemnogene abeparvovec Marketing authorisation applicant Novartis Europharm Limited Therapeutic indication Treatment of 5q spinal muscular…, Redemplo INN plozasiran Marketing authorisation applicant Arrowhead Pharmaceuticals Ireland Limited Therapeutic indication Treatment of familial…, Positive recommendations on new biosimilar medicine, Rexatilux INN ranibizumab Marketing authorisation holder Intas Third Party Sales 2005 S.L. Therapeutic indication Treatment of adults with neovascular (wet)…, Positive recommendations on new generic medicine, Palbociclib Viatris INN palbociclib Marketing authorisation holder Viatris Limited Therapeutic indication Treatment of breast cancer More information…, Positive recommendations on extensions of therapeutic indications , Agamree INN vamorolone Marketing authorisation holder Santhera Pharmaceuticals (Deutschland) GmbH More information Agamree: pending EC decision, Aquipta INN atogepant Marketing authorisation holder Abbvie Deutschland GmbH & Co. KG More information Aquipta: pending EC decision, Comirnaty INN COVID-19 mRNA vaccine Marketing authorisation holder BioNTech Manufacturing GmbH More information Comirnaty: pending EC decision, Crysvita INN burosumab Marketing authorisation holder Kyowa Kirin Holdings B.V. More information Crysvita: pending EC decision, Inaqovi INN decitabine / cedazuridine Marketing authorisation holder Otsuka Pharmaceutical Netherlands B.V. More information Inaqovi: pending EC decision, Opdivo INN nivolumab Marketing authorisation holder Bristol-Myers Squibb Pharma EEIG More information Opdivo: pending EC decision, Privigen INN human normal immunoglobulin Marketing authorisation holder CSL Behring GmbH More information Privigen: pending EC decision, Skyrizi INN risankizumab Marketing authorisation holder Abbvie Deutschland GmbH & Co. KG More information Skyrizi: pending EC decision, Venclyxto INN venetoclax Marketing authorisation holder Abbvie Deutschland GmbH & Co. KG More information Venclyxto: pending EC decision (EMA/VR/…, Withdrawal of initial marketing authorisation application, Viokat INN diazoxide choline Marketing authorisation applicant Soleno Therapeutics Europe Limited Therapeutic indication Treatment of adult and paediatric…, Withdrawal of application to change the marketing authorisation, Pluvicto INN lutetium (177Lu) vipivotide tetraxetan Marketing authorisation holder Novartis Europharm Limited More information Pluvicto: questions and answers…, Other updates Questions and answers on the outcome of assessment on use of Opdualag…

Published: Apr 24, 2026 | Category: EMA | Name: EMA News

Draft concept paper on the development for guidance on demonstration of biosimilarity of biological veterinary medicinal products

Published: Apr 24, 2026 | Category: EMA | Name: EMA Public Consultations

Orphan designation: diazoxide choline Treatment of Prader-Willi syndrome, 12/10/2017 Positive

Published: Apr 24, 2026 | Category: EMA | Name: EMA Orphan

CVMP Interested Parties’ meeting 2026, European Medicines Agency, Amsterdam, the Netherlands, from 20 May 2026, 17:00 (CEST) to 20 May 2026, 19:00 (CEST)

Published: Apr 24, 2026 | Category: EMA | Name: EMA Events

Draft reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in animals in the European Union: development of resistance and impact on public and animal health - Revision 1

Published: Apr 24, 2026 | Category: EMA | Name: EMA Public Consultations

New medicine to reduce triglycerides in adults with familial chylomicronaemia syndrome

EMA has recommended granting a marketing authorisation in the European Union (EU) for Redemplo (plozasiran) to treat adults with familial chylomicronaemia syndrome (FCS).FCS is…

Published: Apr 24, 2026 | Category: EMA | Name: EMA News

EMA business hours over King's Day and Labour Day, 27 April and 1 May

EMA's office is closed for King's Day in the Netherlands on 27 April and for Labour Day on 1 May 2026.Outside of working hours and on public holidays, it is…

Published: Apr 23, 2026 | Category: EMA | Name: EMA News

Orphan designation: aganirsen Prevention of corneal graft rejection, 20/04/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: surovatamig Treatment of large B-cell lymphoma, 20/04/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: 3-(4-((7-Cyano-1-methyl-2-((1-methyl-2-oxo-5-(trifluoromethyl)-1,2-dihydropyridin-3-yl)amino)-1H-imidazo[4,5-b]pyridin-6-yl)oxy)pyridin-2-yl)-1,1-dimethylurea Treatment of myelofibrosis, 20/04/2026 Positive

Orphan designation: 3-(4-((7-Cyano-1-methyl-2-((1-methyl-2-oxo-5-(trifluoromethyl)-1,2-dihydropyridin-3-yl)amino)-1H-imidazo[4,5-b]pyridin-6-yl)oxy)pyridin-2-yl)-1,1-dimethylurea Treatment of myelofibrosis, 20/04/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: adeno-associated virus serotype SLB101 containing the human microdystrophin gene Treatment of Duchenne muscular dystrophy, 20/04/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: antisense oligonucleotide against SYNGAP1 regulatory RNA Treatment of SYNGAP1-related disorder, 20/04/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: upadacitinib Treatment of systemic sclerosis, 20/04/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: coagulation factor V Treatment of congenital factor V deficiency, 20/04/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Momelotinib dihydrochloride monohydrate Treatment of VEXAS syndrome, 20/04/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: daraxonrasib Treatment of pancreatic cancer, 20/04/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: oremepermin alfa Treatment of spinal cord injury, 20/04/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: lisaftoclax Treatment of myelodysplastic syndromes, 13/04/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: acetylleucine Treatment of CACNA1A disorders, 25/03/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: exaluren sulfate Treatment of Alport syndrome, 25/03/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: tacrolimus monohydrate Treatment of vernal keratoconjunctivitis, 25/03/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: atigotatug,nivolumab Treatment of pulmonary neuroendocrine carcinoma, 25/03/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: irpagratinib tosilate monohydrate Treatment of hepatocellular carcinoma, 25/03/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: telisotuzumab adizutecan Treatment of pancreatic cancer, 25/03/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: humanised IgG1 monoclonal antibody against SEZ6, conjugated to (2S)-2-(2-bromoacetamido)-N-[(2S)-1-({3-[(7S)-7-ethyl-7-hydroxy-8,11-dioxo-7,8,11,13-tetrahydro-2H,10H-[1,3]dioxolo[4,5-g]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-14-yl]b

Orphan designation: humanised IgG1 monoclonal antibody against SEZ6, conjugated to (2S)-2-(2-bromoacetamido)-N-[(2S)-1-({3-[(7S)-7-ethyl-7-hydroxy-8,11-dioxo-7,8,11,13-tetrahydro-2H,10H-[1,3]dioxolo[4,5-g]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-14-yl]bicyclo[1.1.1]pentan-1-yl}amino)-1-oxopropan-2-yl]-3-methylbutanamide Treatment of pulmonary neuroendocrine carcinoma, 25/03/2026 Positive

Published: Apr 22, 2026 | Category: EMA | Name: EMA Orphan

Agenda - PDCO agenda of the 21-24 April 2026 meeting

Published: Apr 21, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Orphan designation: dibotatug Treatment of large granular lymphocytic leukaemia, 25/03/2026 Positive

Published: Apr 20, 2026 | Category: EMA | Name: EMA Orphan

Committee for Medicinal Products for Human Use (CHMP): 20-23 April 2026, European Medicines Agency, Amsterdam, the Netherlands, from 20 April 2026 to 23 April 2026

Published: Apr 20, 2026 | Category: EMA | Name: EMA Events

Annex to agenda of the CHMP meeting 20-23 April 2026

Published: Apr 20, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the CHMP meeting 20-23 April 2026

Published: Apr 20, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Orphan designation: dusquetide Treatment of Behçet's Disease, 25/03/2026 Positive

Published: Apr 20, 2026 | Category: EMA | Name: EMA Orphan

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 April 2026

CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion for a marketing authorisation for Nobivac NXT HCPChFeLV, for the active immunisation of…

Published: Apr 17, 2026 | Category: EMA | Name: EMA News

EMA recommends authorisation of first veterinary vaccine using RNA technology

EMA has recommended granting a marketing authorisation in the EU for Nobivac NXT HCPChFeLV, a vaccine for protecting cats against common infectious diseases.The vaccine…

Published: Apr 17, 2026 | Category: EMA | Name: EMA News

Minutes - HMA-EMA joint Network Data Steering Group meeting - 9 March 2026

Published: Apr 16, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - June 2026, Online, from 11 June 2026, 15:00 (CEST) to 11 June 2026, 16:00 (CEST)

Published: Apr 16, 2026 | Category: EMA | Name: EMA Events

Q&A clinic on Substance, Organisation, Referentials Management Services - June 2026, Online, from 10 June 2026, 15:30 (CEST) to 10 June 2026, 16:00 (CEST)

Published: Apr 16, 2026 | Category: EMA | Name: EMA Events

Q&A clinic on Substance, Organisation, Referentials Management Services - June, Online, from 10 June 2026, 15:30 (CEST) to 10 June 2026, 16:00 (CEST)

Published: Apr 16, 2026 | Category: EMA | Name: EMA Events

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 15 April 2026, 09:30 (CEST) to 15 April 2026, 13:00 (CEST)

Published: Apr 15, 2026 | Category: EMA | Name: EMA Events

Orphan designation: risvutatug rezetecan Treatment of pulmonary neuroendocrine carcinoma, 20/10/2025 Positive

Published: Apr 14, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: glial cell line-derived neurotrophic factor,sodium butyrate Treatment of Hirschsprung's disease, 20/10/2025 Positive

Published: Apr 14, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: mezagitamab Treatment of primary IgA nephropathy, 20/10/2025 Positive

Published: Apr 14, 2026 | Category: EMA | Name: EMA Orphan

European Medicines Agency meeting with senior representatives of pharmaceutical companies, European Medicines Agency, Amsterdam, the Netherlands, 17 April 2026

Published: Apr 14, 2026 | Category: EMA | Name: EMA Events

Orphan designation: nangibotide Treatment of biliary tract cancer, 21/11/2025 Positive

Published: Apr 14, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: non-replicating adeno-associated virus serotype 5 containing the human retinal guanylate cyclase 1 gene Treatment of inherited retinal dystrophy due to biallelic autosomal recessive mutations in the human guanylate cyclase 1 (GUCY2D) g

Orphan designation: non-replicating adeno-associated virus serotype 5 containing the human retinal guanylate cyclase 1 gene Treatment of inherited retinal dystrophy due to biallelic autosomal recessive mutations in the human guanylate cyclase 1 (GUCY2D) gene, 23/02/2026 Positive

Published: Apr 14, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: orziloben Treatment of intestinal failure-associated liver disease Positive

Published: Apr 14, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: aviptadil Treatment of acute respiratory distress syndrome (ARDS), 23/02/2026 Positive

Published: Apr 14, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: 1-{[2-(3,6-Diazabicyclo[3.1.1]heptan-3-yl)-7-(1,3-thiazol-2-yl)-1,3-benzoxazol-4-yl]oxy}-1,1-difluoro-2-methylpropan-2-ol Treatment of palmoplantar pustulosis Positive

Published: Apr 14, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: rinatabart sesutecan Treatment of ovarian cancer Positive

Published: Apr 14, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: adeno-associated viral vector serotype 44.9 containing the human HRS1 gene Treatment of inherited retinal dystrophy due to dysfunction in the human retinoschisin (RS1) gene, 23/02/2026 Positive

Orphan designation: adeno-associated viral vector serotype 44.9 containing the human HRS1 gene Treatment of inherited retinal dystrophy due to dysfunction in the human retinoschisin (RS1) gene, 23/02/2026 Positive

Published: Apr 14, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: sefaxersen Treatment of primary IgA nephropathy, 23/02/2026 Positive

Published: Apr 14, 2026 | Category: EMA | Name: EMA Orphan

Committee for Medicinal Products for Veterinary Use (CVMP): 14-16 April 2026, European Medicines Agency, Amsterdam, the Netherlands, from 14 April 2026 to 16 April 2026

Published: Apr 14, 2026 | Category: EMA | Name: EMA Events

Orphan designation: povetacicept Treatment of primary membranous nephropathy, 23/02/2026 Positive

Published: Apr 13, 2026 | Category: EMA | Name: EMA Orphan

PDCO minutes of the 24-27 February 2026 meeting

Published: Apr 13, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Orphan designation: 2-[[(4-Methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazol-5-ol Treatment of multiple system atrophy, 09/01/2026 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: lanthanum carbonate octahydrate Treatment of primary hyperoxaluria, 09/01/2026 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: sirolimus Treatment of osteosarcoma, 09/01/2026 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Adeno-associated virus serotype ATC-0187 vector containing the human BAG3 gene Treatment of BAG3 dilated cardiomyopathy, 09/01/2026 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: spironolactone Treatment of central serous chorioretinopathy, 09/01/2026 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Phe-Thr-Thr-Phe-Thr-Val-Thr Treatment of idiopathic pulmonary fibrosis, 09/01/2026 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: (4Z,7R,8E,10E,12Z,14S,16Z,19Z)-7,14-Dihydroxydocosa-4,8,10,12,16,19-hexaenoic acid Treatment of spinal cord injury, 23/02/2026 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: spironolactone Treatment of limbal stem cell deficiency, 23/02/2026 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Measles virus Schwarz strain (live, attenuated) Treatment of mesothelioma, 23/02/2026 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Humanised IgG1 kappa monoclonal antibody against erythropoietin isoform EV-3 Treatment of glioma, 23/02/2026 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: N-[(1S)-1-(4-Tert-butylphenyl) ethyl]-2-(6,7-difluoro-1H-benzimidazol-1-yl)acetamide Treatment of erythromelalgia, 23/02/2026 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: autologous peripheral blood-derived CD34+ haematopoietic stem and progenitor cells transduced with a lentiviral vector containing the murine Glb1 gene Treatment of Glb1-related disorders, 22/10/2025 Positive

Orphan designation: autologous peripheral blood-derived CD34+ haematopoietic stem and progenitor cells transduced with a lentiviral vector containing the murine Glb1 gene Treatment of Glb1-related disorders, 22/10/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: (S)-1-(2,2-Difluoroethyl)-3-(difluoromethyl)-N-(1-(3-(2-methoxypyridin-4-yl)-1,2,4-oxadiazol-5-yl)ethyl)-1H-pyrazole-5-carboxamide Treatment of KCNT1-related epilepsy and neurodevelopmental disorders, 21/11/2025 Positive

Orphan designation: (S)-1-(2,2-Difluoroethyl)-3-(difluoromethyl)-N-(1-(3-(2-methoxypyridin-4-yl)-1,2,4-oxadiazol-5-yl)ethyl)-1H-pyrazole-5-carboxamide Treatment of KCNT1-related epilepsy and neurodevelopmental disorders, 21/11/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: vopimetostat Treatment of pancreatic cancer, 21/11/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2026

New safety information for healthcare professionals Ontozry (cenobamate): new requirements for liver monitoring due to reports of severe liver injuryPRAC agreed on a direct…, Agenda Agenda of the PRAC meeting 7-10 April 2026Draft Reference…, PRAC statistics: April 2026 , PRAC statistics: April 2026 English (EN) (33.18 MB - PDF)First published…, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between…

Published: Apr 10, 2026 | Category: EMA | Name: EMA News

Orphan designation: admilparant Treatment of idiopathic pulmonary fibrosis, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: 4-(2-{[2-Amino-6-(3-chloro-2-methylphenyl)pyrimidin-4-yl]amino}ethyl)benzene-1-sulfonamide Treatment of acute myeloid leukaemia, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: gildeuretinol, gildeuretinol acetate Treatment of non-syndromic inherited retinal dystrophies due to defects in the ABCA4 gene, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: RNA editing antisense oligonucleotide against the Z mutation of the human SERPINA1 mRNA transcript, sodium salt Treatment of alpha-1 antitrypsin deficiency, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: adeno-associated viral vector serotype ShH10 containing a codon-optimised human NDP gene Treatment of NDP gene-related disorders Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: IgG1 trispecific monoclonal antibody against T-cell receptor CD3, B-cell maturation antigen and G protein-coupled receptor class C group 5 member D Treatment of multiple myeloma Positive

Orphan designation: IgG1 trispecific monoclonal antibody against T-cell receptor CD3, B-cell maturation antigen and G protein-coupled receptor class C group 5 member D Treatment of multiple myeloma Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: sonpiretigene isteparvovec Treatment of syndromic inherited retinal dystrophies of the rod-dominant phenotype, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: darovasertib Treatment of uveal melanoma, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: acetylcysteine amide Treatment of hereditary cerebral amyloid angiopathies, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: emugrobart Treatment of spinal muscular atrophy, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: RNA, [P-deoxy-P-(dimethylamino)](2',3'-dideoxy-2',3'-imino-2',3'-seco)(2'a->5') (C-A-G-C-A-G-C-A-G-C-A-G-C-A-G-C-A-G-C-A-[2'a-[39-[[1-acetyl-L-prolyl-L-lysyl-L-lysyl-L-lysyl-L-arginyl-L-lysyl-L-valyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N

Orphan designation: RNA, [P-deoxy-P-(dimethylamino)](2',3'-dideoxy-2',3'-imino-2',3'-seco)(2'a->5') (C-A-G-C-A-G-C-A-G-C-A-G-C-A-G-C-A-G-C-A-[2'a-[39-[[1-acetyl-L-prolyl-L-lysyl-L-lysyl-L-lysyl-L-arginyl-L-lysyl-L-valyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-(L-phenylalanylglycyl-L-phenylalanylglycyl-L-arginylglycyl-L-arginyl-L-gamma-glutamyl)-L-lysyl]amino]-1- oxo-4,7,10,13,16,19,22,25,28,31,34,37-dodecaoxanonatriacont-1-yl]]G), (8'->1')-lactam Treatment of dystrophic myotonia, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: rilzabrutinib Treatment of immunoglobulin G4-related disease, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: adeno-associated virus serotype 9 vector containing the human NDP gene Treatment of NDP gene-related disorders, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: mezagitamab Treatment of immune thrombocytopenia, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: 7-ethyl-10-hydroxycamptothecin Treatment of pancreatic cancer, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: pegtarazimod Treatment of graft-versus-host disease, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: lentiviral vector containing the human MMUT transgene Treatment of methylmalonic acidaemia, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: 2'-O-(2-Methoxyethyl) modified antisense oligonucleotide against MECP2 pre-mRNA Treatment of MECP2 duplication syndrome, 21/11/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: cladribine Treatment of acute myeloid leukaemia, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: 2-(3-Chlorophenyl)-N-[6-(trifluoromethyl)-1,3-benzothiazol-2-yl]acetamide Treatment of amyotrophic lateral sclerosis, 21/11/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: mRNA encoding Cas12HF endonuclease, Single guide RNA against the human HAO1 gene Treatment of primary hyperoxaluria, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: 3-tert-butyl-N-{(1R)-1-[4-(6-{6-[4-({1-[4-(2,4-dioxo-1,3-diazinan-1-yl)phenyl]piperidin-4-yl}methyl)piperazin-1-yl]pyridin-3-yl}-7H-pyrrolo[2,3-d]pyrimidin-4-yl)-2-methylphenyl]ethyl}-1,2,4-oxadiazole-5-carboxamide Treatment of lymphop

Orphan designation: 3-tert-butyl-N-{(1R)-1-[4-(6-{6-[4-({1-[4-(2,4-dioxo-1,3-diazinan-1-yl)phenyl]piperidin-4-yl}methyl)piperazin-1-yl]pyridin-3-yl}-7H-pyrrolo[2,3-d]pyrimidin-4-yl)-2-methylphenyl]ethyl}-1,2,4-oxadiazole-5-carboxamide Treatment of lymphoplasmacytic lymphoma, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: sonpiretigene isteparvovec Treatment of non-syndromic macular dystrophy, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: brepocitinib Treatment of idiopathic inflammatory myopathy, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: antisense oligonucleotide against ABCA4 pre-mRNA Treatment of non-syndromic inherited retinal dystrophies due to defects in the ABCA4 gene, 21/11/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: temozolomide Treatment of glioma, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: varegacestat Treatment of soft tissue sarcoma, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: zilurgisertib Treatment of fibrodysplasia ossificans progressiva, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: sonpiretigene isteparvovec Treatment of syndromic inherited retinal dystrophies of the cone-dominant phenotype, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: sonpiretigene isteparvovec Treatment of non-syndromic inherited retinal dystrophies of the rod-dominant phenotype, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: methotrexate Treatment of primary large B-cell lymphoma of immune-privileged sites, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: sonpiretigene isteparvovec Treatment of non-syndromic inherited retinal dystrophies of the cone-dominant phenotype, 22/08/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: leuconostoc citreum, strain G511, Live Treatment of primary sclerosing cholangitis, 21/11/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: orvepitant maleate Treatment of idiopathic pulmonary fibrosis, 21/11/2025 Positive

Published: Apr 10, 2026 | Category: EMA | Name: EMA Orphan

European Platform for Regulatory Science Research meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 April 2026, 13:00 (CEST) to 30 April 2026, 17:00 (CEST)

Published: Apr 8, 2026 | Category: EMA | Name: EMA Events

Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 April 2026, European Medicines Agency, Amsterdam, the Netherlands, from 7 April 2026 to 10 April 2026

Published: Apr 7, 2026 | Category: EMA | Name: EMA Events

CHMP PROM minutes for the meeting on 6 October 2025

Published: Apr 7, 2026 | Category: EMA | Name: EMA Agenda and Minutes

CHMP PROM minutes for the meeting on 8 September 2025

Published: Apr 7, 2026 | Category: EMA | Name: EMA Agenda and Minutes

CHMP PROM minutes for the meeting on 14 July 2025

Published: Apr 7, 2026 | Category: EMA | Name: EMA Agenda and Minutes

CHMP PROM minutes for the meeting on 10 June 2025

Published: Apr 7, 2026 | Category: EMA | Name: EMA Agenda and Minutes

CHMP PROM minutes for the meeting on 12 May 2025

Published: Apr 7, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Highlights - EMA - European Alliance of Associations for Rheumatology (EULAR) bilateral meeting - March 2026

Published: Apr 7, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Breakthrough medical devices: information session, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 April 2026, 15:00 (CEST) to 24 April 2026, 17:00 (CEST)

Published: Apr 1, 2026 | Category: EMA | Name: EMA Events

Minutes of the COMP meeting 17-19 February 2026

Published: Apr 1, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Draft ‘Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products’ - Revision 2

Published: Apr 1, 2026 | Category: EMA | Name: EMA Public Consultations

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 17 February 2026, 09:30 (CET) to 17 February 2026, 13:00 (CET)

Published: Apr 1, 2026 | Category: EMA | Name: EMA Events

Paediatric addendum to CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

Published: Mar 31, 2026 | Category: EMA | Name: EMA Public Consultations

Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis

Published: Mar 31, 2026 | Category: EMA | Name: EMA Public Consultations

EMA consults on virtual control groups to help reduce animal use in medicines development

EMA’s human medicines committee (CHMP) has issued a draft qualification opinion for a new methodology in preclinical research, which can reduce the overall number of…

Published: Mar 31, 2026 | Category: EMA | Name: EMA News

Draft Qualification opinion for Virtual Control Groups (VCG) to replace Concurrent Control Groups (CCG) in rat non-GLP Dose-Range Finding (DRF) studies

Published: Mar 31, 2026 | Category: EMA | Name: EMA Public Consultations

EMA business hours over Easter holiday period

EMA's office is closed from 18:00 on Wednesday 1 April 2026 to 08:30 on Tuesday 7 April 2026.Outside of working hours and on public holidays, it is possible to call the…

Published: Mar 31, 2026 | Category: EMA | Name: EMA News

EnprEMA & ACT EU workshop on paediatric clinical trials, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 May 2026, 10:00 (CEST) to 12 May 2026, 17:00 (CEST)

Published: Mar 27, 2026 | Category: EMA | Name: EMA Events

Orphan designation: N-[[(2S)-4-[(4-Methyl-1H-imidazol-5-yl)methyl]-3-oxo-2-(phenylmethyl)-1-piperazinyl]carbonyl]-L-leucine trihydrate Treatment of cutaneous T-cell lymphoma, 09/12/2025 Positive

Published: Mar 27, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: domvanalimab Treatment of gastric cancer, 09/12/2025 Positive

Published: Mar 27, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: [4-(6-aminopyridazin-3-yl)piperidin-1-yl][5-(4-fluorophenoxy)-4-methoxypyridin-2-yl]methanone Treatment of focal segmental glomerulosclerosis, 09/12/2025 Positive

Published: Mar 27, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: amsulostat Treatment of myelofibrosis, 09/12/2025 Positive

Published: Mar 27, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: efdoralprin alfa Treatment of alpha-1 antitrypsin deficiency, 09/12/2025 Positive

Published: Mar 27, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: surovatamig Treatment of B-lymphoblastic leukaemia/lymphoma, 21/11/2025 Positive

Published: Mar 27, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: rezatapopt Treatment of ovarian cancer, 09/12/2025 Positive

Published: Mar 27, 2026 | Category: EMA | Name: EMA Orphan

New treatment for relapsed extensive-stage small cell lung cancer

EMA has recommended granting a marketing authorisation in the European Union (EU) for Imdylltra (tarlatamab) as monotherapy to treat adults with extensive-stage small cell lung…

Published: Mar 27, 2026 | Category: EMA | Name: EMA News

Orphan designation: tarlatamab Treatment of small cell lung cancer, 12/01/2024 Positive

Published: Mar 27, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: lurbinectedin Treatment of small cell lung cancer, 26/02/2019 Positive

Published: Mar 27, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: Leniolisib Treatment of activated phosphoinositide 3-kinase delta syndrome, 19/10/2020 Positive

Published: Mar 27, 2026 | Category: EMA | Name: EMA Orphan

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2026

Five new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2026 meeting.The committee recommended…, CHMP statistics Key figures from the March 2026 CHMP meeting are represented in the graphic below. , CHMP statistics:…, Positive recommendations on new medicines, Adstiladrin INN nadofaragene firadenovec  Marketing authorisation applicant Ferring Pharmaceuticals A/S Therapeutic indication Treatment of adult…, Imdylltra INN tarlatamab Marketing authorisation applicant Amgen Europe B.V Therapeutic indication Treatment of extensive-stage small cell lung cancer. More…, Joenja INN leniolisib  Marketing authorisation applicant Pharming Technologies B.V. Therapeutic indication Treatment of activated phosphoinositide 3-…, Zepzelca INN lurbinectedin Marketing authorisation applicant Pharma Mar S.A. Therapeutic indication Maintenance treatment of adult patients with extensive-…, Positive recommendations on new hybrid medicines, Bopediat INN furosemide  Marketing authorisation holder Proveca Pharma Limited Therapeutic indication Treatment of all conditions requiring diuresis due…, Positive recommendations on extensions of therapeutic indications , Besponsa INN inotuzumab ozogamicin Marketing authorisation holder Pfizer Europe MA EEIG More information Besponsa : pending EC decision, Capvaxive INN pneumococcal polysaccharide conjugate vaccine (21-valent) Marketing authorisation holder Merck Sharp & Dohme B.V.  More information…, Feraccru INN ferric maltol Marketing authorisation holder Norgine B.V. More information Feraccru : pending EC decision, Hetronifly INN serplulimab Marketing authorisation holder Accord Healthcare S.L.U. More information Hetronifly: pending EC decision (EMA/VR/0000284402)…, Hympavzi INN marstacimab Marketing authorisation holder Pfizer Europe MA EEIG More information Hympavzi : pending EC decision, Imcivree INN setmelanotide Marketing authorisation holder Rhythm Pharmaceuticals Netherlands B.V. More information Imcivree : pending EC decision, Lojuxta INN lomitapide Marketing authorisation holder Chiesi Farmaceutici SpA More information Lojuxta : pending EC decision, Mekinist INN trametinib Marketing authorisation holder Novartis Europharm Limited More information Mekinist : pending EC decision (EMAVR0000271728)Mekinist…, Mresvia INN respiratory syncytial virus mRNA vaccine (nucleoside modified) Marketing authorisation holder Moderna Biotech Spain, S.L. More information…, Namuscla INN mexiletine hcl Marketing authorisation holder Lupin Europe GmbH More information Namuscla : pending EC decision, Retsevmo INN selpercatinib Marketing authorisation holder Eli Lilly Nederland B.V. More information Retsevmo : pending EC decision, Sotyktu INN seucravacitinib  Marketing authorisation holder Bristol-Myers Squibb Pharma EEIG More information Sotyktu : pending EC decision, Tafinlar INN dabrafenib Marketing authorisation holder Novartis Europharm Limited More information Tafinlar : pending EC decision (EMAVR0000271728)Tafinlar…, Outcome of re-examination, Hetlioz INN tasimelteon  Marketing authorisation holder Vanda Pharmaceuticals Netherlands B.V. More information Hetlioz, Withdrawal of application, Blarcamesine Anavex INN blarcamesine  Marketing authorisation applicant Anavex Germany GmbH Therapeutic indication Treatment of Alzheimer’s disease…, Referral procedures, Tecovirimat SIGA INN tecovirimat More information Tecovirimat SIGA , Other updates, Sarclisa INN isatuximab Marketing authorisation holder Sanofi Winthrop Industrie More information Sarclisa : pending EC decision, Reflection paper on a tailored clinical approach in biosimilar developmentAdopted…

Published: Mar 27, 2026 | Category: EMA | Name: EMA News

EMA recommends restricting use of Tecovirimat SIGA

EMA’s committee for human medicines, CHMP, has recommended that Tecovirimat SIGA should no longer be used for the treatment of mpox. This recommendation does not affect the…

Published: Mar 27, 2026 | Category: EMA | Name: EMA News

Orphan designation: puliretgene parvec Treatment of inherited retinal dystrophy due to dysfunction in the CYP4V2-gene, 12/09/2025 Positive

Published: Mar 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: zimberelimab Treatment of oesophageal cancer, 12/09/2025 Positive

Published: Mar 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: autologous peripheral blood-derived CD34+ haematopoietic stem and progenitor cells transduced with a lentiviral vector containing the human MAN2B1 gene Treatment of alpha-mannosidosis, 12/09/2025 Positive

Orphan designation: autologous peripheral blood-derived CD34+ haematopoietic stem and progenitor cells transduced with a lentiviral vector containing the human MAN2B1 gene Treatment of alpha-mannosidosis, 12/09/2025 Positive

Published: Mar 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: cyclo(arginyl-glycyl-aspartyl-D-tyrosyl-lysyl)-nizaracianine-1 Diagnosis of pancreatic cancer, 12/09/2025 Positive

Published: Mar 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: domvanalimab Treatment of oesophageal cancer, 12/09/2025 Positive

Published: Mar 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: humanised IgG1 kappa monoclonal antibody against pregnancy-associated plasma protein A Treatment of autosomal dominant polycystic kidney disease, 12/09/2025 Positive

Published: Mar 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: biotin Treatment of biotin-thiamine-responsive basal ganglia disease (BTBGD), 12/09/2025 Positive

Published: Mar 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: human IgG1 monoclonal antibody against tumor necrosis factor receptor superfamily member 1B Treatment of cutaneous T-cell lymphoma, 12/09/2025 Positive

Published: Mar 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: zimberelimab Treatment of gastric cancer, 12/09/2025 Positive

Published: Mar 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: adeno-associated virus vector serotype 6.2 containing human TERT gene Treatment of idiopathic pulmonary fibrosis, 12/09/2025 Positive

Published: Mar 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: iniparib Treatment of glioma, 12/09/2025 Positive

Published: Mar 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: potravitug Treatment in solid organ transplantation, 15/12/2025 Positive

Published: Mar 26, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: deupirfenidone Treatment idiopathic pulmonary fibrosis, 09/01/2026 Positive

Published: Mar 25, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: canvuparatide Treatment of hypoparathyroidism, 09/01/2026 Positive

Published: Mar 25, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: human IgG1 kappa monoclonal antibody against pappalysin-1 Treatment of autosomal dominant polycystic kidney disease, 09/01/2026 Positive

Published: Mar 25, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: navtemadlin Treatment of myelofibrosis, 09/01/2026 Positive

Published: Mar 25, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: saracatinib Treatment of fibrodysplasia ossificans progressiva, 09/01/2026 Positive

Published: Mar 25, 2026 | Category: EMA | Name: EMA Orphan

Orphan designation: alpibectir,ethionamide Treatment of tuberculosis Positive

Published: Mar 25, 2026 | Category: EMA | Name: EMA Orphan

ACT EU webinar on draft guidance on the conduct of clinical trials during public health emergencies, Online, from 8 April 2026, 10:00 (CEST) to 8 April 2026, 11:30 (CEST)

Published: Mar 25, 2026 | Category: EMA | Name: EMA Events

Names of the European Union / European Economic Area countries

Published: Mar 25, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Tables of non-standard abbreviations to be used in the summary of product characteristics

Published: Mar 25, 2026 | Category: EMA | Name: EMA Procedural Guidelines

20th anniversary of European Medicines Agency's Patients' and Consumers' Working Party (PCWP), Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 June 2026, 13:30 (CEST) to 30 June 2026, 17:30 (CEST)

20th anniversary of European Medicines Agency's Patients' and Consumers' Working Party (PCWP), Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 June 2026, 13:30 (CEST) to 30 June 2026, 17:30 (CEST)

Published: Mar 25, 2026 | Category: EMA | Name: EMA Events

Mobile scanning and other technologies in the labelling and/or package leaflet of centrally authorised medicinal products

Published: Mar 25, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Minutes – Ad hoc Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 5 March 2026

Published: Mar 24, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Paediatric Committee (PDCO): 24-27 March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 March 2026 to 27 March 2026

Published: Mar 24, 2026 | Category: EMA | Name: EMA Events

Meeting of the Executive Steering Group on Shortages of Medical Devices (MDSSG), Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 March 2026, 09:00 (CET) to 23 March 2026, 10:00 (CET)

Meeting of the Executive Steering Group on Shortages of Medical Devices (MDSSG), Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 March 2026, 09:00 (CET) to 23 March 2026, 10:00 (CET)

Published: Mar 23, 2026 | Category: EMA | Name: EMA Events

EMA traineeship programme informative session, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 14 April 2026, 10:00 (CEST) to 14 April 2026, 11:00 (CEST)

Published: Mar 20, 2026 | Category: EMA | Name: EMA Events

EMA workshop on the challenges in drug development, regulation and clinical practice in immune thrombocytopenia, Online, 30 June 2026

Published: Mar 20, 2026 | Category: EMA | Name: EMA Events

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - April 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 April 2026, 09:30 (CEST) to 24 April 2026, 11:30 (CEST)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - April 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 April 2026, 09:30 (CEST) to 24 April 2026, 11:30 (CEST)

Published: Mar 20, 2026 | Category: EMA | Name: EMA Events

European Shortages Monitoring Platform (ESMP) training on readable IDs and general updates for industry, Online, from 14 April 2026, 10:00 (CEST) to 14 April 2026, 11:00 (CEST)

Published: Mar 20, 2026 | Category: EMA | Name: EMA Events

New PRIME tools to accelerate development of medicines in the EU

EMA launched three major new features of PRIME, the Agency’s scheme to enhance support for the development of medicines targeting an unmet medical need. After the completion of…, "Over the ten years since its launch, PRIME has continued to evolve to keep pace with scientific innovation and accelerate the development and assessment of…, The results of the pilot indicate that the new PRIME features promote enhanced regulatory agility and better support to developers. They also come at a crucial time as EMA…

Published: Mar 18, 2026 | Category: EMA | Name: EMA News

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, European Medicines Agency, Amsterdam, the Netherlands, from 16 March 2026, 10:00 (CET) to 17 March 2026, 16:00 (CET)

Published: Mar 17, 2026 | Category: EMA | Name: EMA Events

Agenda - Medicine Shortages SPOC Working Party meeting 16-17 March 2026

Published: Mar 17, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Committee for Orphan Medicinal Products (COMP): 17-19 March 2026, European Medicines Agency, Amsterdam, the Netherlands, from 17 March 2026 to 19 March 2026

Published: Mar 17, 2026 | Category: EMA | Name: EMA Events

Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 16 March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 March 2026, 14:00 (CET) to 16 March 2026, 16:00 (CET)

Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 16 March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 March 2026, 14:00 (CET) to 16 March 2026, 16:00 (CET)

Published: Mar 16, 2026 | Category: EMA | Name: EMA Events

Workshop on Vulnerability Assessment, Online, European Medicines Agency, Amsterdam, the Netherlands, from 18 March 2026, 09:30 (CET) to 18 March 2026, 12:30 (CET)

Published: Mar 16, 2026 | Category: EMA | Name: EMA Events

EMA - Alzheimer Europe (AE) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 January 2026, 14:00 (CET) to 20 January 2026, 15:00 (CET)

Published: Mar 16, 2026 | Category: EMA | Name: EMA Events

ACT EU webinar on contractual agreements , Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 April 2026, 09:00 (CEST) to 16 April 2026, 12:30 (CEST)

Published: Mar 16, 2026 | Category: EMA | Name: EMA Events

EMA Management Board: highlights of March 2026 meeting

EMA annual report 2025The Management Board adopted EMA’s annual report for 2025, marking another strong year for medicines regulation in the European Union. EMA delivered 104…

Published: Mar 13, 2026 | Category: EMA | Name: EMA News

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 March 2026

CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion for a marketing authorisation for AviGate S. Infantis, for active immunisation of…

Published: Mar 13, 2026 | Category: EMA | Name: EMA News

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 March 2026

PRAC warns about known risk of aseptic meningitis with chikungunya vaccine IxchiqUpdate to product information recommended to reflect recent evidenceEMA’s safety committee (…, Agenda Agenda of the PRAC meeting 9-12 March 2026Draft Reference…, PRAC statistics: March 2026 , PRAC statistics: March 2026 English (EN) (10.77 MB - PDF)First published…, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between…

Published: Mar 13, 2026 | Category: EMA | Name: EMA News

Management Board meeting: 12 March 2026, European Medicines Agency, Amsterdam, the Netherlands, 12 March 2026

Published: Mar 13, 2026 | Category: EMA | Name: EMA Events

Minutes - HMA-EMA joint Network Data Steering Group meeting - 11 February 2026

Published: Mar 13, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Concept paper on the development of a reflection paper on proof-of-concept data to support the development of anti-cancer medicinal products in paediatric patients

Published: Mar 13, 2026 | Category: EMA | Name: EMA Public Consultations

Clinical Trials Information System (CTIS): Walk-in clinic April 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 16 April 2026, 16:00 (CEST) to 16 April 2026, 17:00 (CEST)

Clinical Trials Information System (CTIS): Walk-in clinic April 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 16 April 2026, 16:00 (CEST) to 16 April 2026, 17:00 (CEST)

Published: Mar 12, 2026 | Category: EMA | Name: EMA Events

Minutes of the COMP meeting 20-22 January 2026

Published: Mar 11, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the CVMP meeting 10-12 March 2026

Published: Mar 11, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the PRAC meeting 12 - 15 January 2026

Published: Mar 11, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - Management Board meeting: 12 March 2026

Published: Mar 11, 2026 | Category: EMA | Name: EMA Agenda and Minutes

PCWP/HCPWP joint meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 June 2026, 09:30 (CEST) to 1 July 2026, 12:00 (CEST)

Published: Mar 10, 2026 | Category: EMA | Name: EMA Events

Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 March 2026, European Medicines Agency, Amsterdam, the Netherlands, from 10 March 2026 to 12 March 2026

Published: Mar 10, 2026 | Category: EMA | Name: EMA Events

PCWP 20th anniversary plenary and PCWP/HCPWP joint meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 June 2025, 09:30 (CEST) to 1 July 2025, 12:00 (CEST)

Published: Mar 9, 2026 | Category: EMA | Name: EMA Events

Agenda of the PRAC meeting 9-12 March 2026

Published: Mar 9, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the HMPC meeting 19-21 January 2026

Published: Mar 6, 2026 | Category: EMA | Name: EMA Agenda and Minutes

EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports

Published: Mar 6, 2026 | Category: EMA | Name: EMA Scientific Guidelines

New guidance on the conduct of clinical trials during public health emergencies in the EU

The Accelerating Clinical Trials in the EU (ACT EU) initiative has published a draft guidance document outlining how clinical trials should be conducted during public health…

Published: Mar 5, 2026 | Category: EMA | Name: EMA News

Agenda - Ad hoc Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 5 March 2026

Published: Mar 5, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 5 March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 5 March 2026, 15:15 (CET) to 5 March 2026, 16:15 (CET)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 5 March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 5 March 2026, 15:15 (CET) to 5 March 2026, 16:15 (CET)

Published: Mar 5, 2026 | Category: EMA | Name: EMA Events

Draft guidance on the conduct of clinical trials during public health emergencies

Published: Mar 4, 2026 | Category: EMA | Name: EMA Public Consultations

Minutes of the CAT meeting 21-23 January 2026

Published: Mar 4, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Human medicines: highlights of 2022

Update as of 3 March 2026This news was updated to accurately reflect the number of medicines with a new active substance recommended for marketing authorisation.In 2022, EMA…

Published: Mar 3, 2026 | Category: EMA | Name: EMA News

3Rs Working Party (3RsWP) stakeholder meeting - Public session on the 2026-2028 work plan, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 31 March 2026, 09:30 (CEST) to 31 March 2026, 10:30 (CEST)

3Rs Working Party (3RsWP) stakeholder meeting - Public session on the 2026-2028 work plan, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 31 March 2026, 09:30 (CEST) to 31 March 2026, 10:30 (CEST)

Published: Mar 2, 2026 | Category: EMA | Name: EMA Events

Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - February 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 February 2026, 15:00 (CET) to 12 February 2026, 16:00 (CET)

Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - February 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 February 2026, 15:00 (CET) to 12 February 2026, 16:00 (CET)

Published: Mar 2, 2026 | Category: EMA | Name: EMA Events

European Medicines Agency (EMA) and European Alliance of Associations for Rheumatology (EULAR) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 18 March 2026, 14:00 (CET) to 18 March 2026, 16:00 (CET)

European Medicines Agency (EMA) and European Alliance of Associations for Rheumatology (EULAR) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 18 March 2026, 14:00 (CET) to 18 March 2026, 16:00 (CET)

Published: Mar 2, 2026 | Category: EMA | Name: EMA Events

Draft concept paper on the development of a reflection paper on the non-clinical development and evaluation of microbiome-based medicinal products

Published: Mar 2, 2026 | Category: EMA | Name: EMA Public Consultations

Meeting of the HMA-EMA group focused on AI with industry stakeholders - February 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 4 February 2026, 10:00 (CET) to 4 February 2026, 11:30 (CET)

Meeting of the HMA-EMA group focused on AI with industry stakeholders - February 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 4 February 2026, 10:00 (CET) to 4 February 2026, 11:30 (CET)

Published: Feb 27, 2026 | Category: EMA | Name: EMA Events

Sustainability: Quality Innovation Group (QIG) listen and learn focus group meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 4 March 2026 to 5 March 2026

Published: Feb 27, 2026 | Category: EMA | Name: EMA Events

Quality Innovation Group (QIG): Listen and learn focus group meeting on sustainability, Online, European Medicines Agency, Amsterdam, the Netherlands, from 4 March 2026 to 5 March 2026

Published: Feb 27, 2026 | Category: EMA | Name: EMA Events

Agenda of the HMPC meeting 2-4 March 2026

Published: Feb 27, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 2026

12 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its February 2026 meeting.The committee recommended…, CHMP statistics Key figures from the February 2026 CHMP meeting are represented in the graphic below. , CHMP statistics:…, Positive recommendations on new medicines, mCombriax Common name Influenza and COVID 19, mRNA vaccine Marketing authorisation applicant Moderna Biotech Spain S.L. Therapeutic indication Immunisation…, Ojemda INN tovorafenib  Marketing authorisation applicant Ipsen Pharma  Therapeutic indication Treatment of paediatric low-grade glioma (LGG).…, Onerji INN levodopa / carbidopa  Marketing authorisation applicant Tanabe Pharma GmbH Therapeutic indication Treatment of motor fluctuations in patients…, Palsonify INN paltusotine Marketing authorisation applicant Crinetics Pharmaceuticals Europe GmbH Therapeutic indication Medical treatment of adult patients…, Rhapsido INN remibrutinib Marketing authorisation applicant Novartis Europharm Limited Therapeutic indication Treatment of chronic spontaneous urticaria (CSU…, Xolremdi INN mavorixafor Marketing authorisation applicant X4 Pharmaceuticals (Austria) GmbH Therapeutic indication Treatment of WHIM syndrome. More…, Positive recommendations on new biosimilar medicines, Bysumlog INN insulin lispro  Marketing authorisation holder Gan & Lee Pharmaceuticals Europe GmbH Therapeutic indication Treatment of diabetes…, Dazparda INN insulin aspart  Marketing authorisation applicant Gan & Lee Pharmaceuticals Europe GmbH Therapeutic indication Treatment of diabetes…, Fubelv INN etanercept  Marketing authorisation holder Biosimilar Collaborations Ireland Limited Therapeutic indication Treatment of rheumatoid arthritis…, Poherdy INN pertuzumab Marketing authorisation holder Organon N.V. Therapeutic indication Treatment of breast cancer in adults.  More information…, Tuyory INN tocilizumab  Marketing authorisation holder Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.) Therapeutic indication Treatment of…, Zandoriah INN teriparatide  Marketing authorisation holder Cinnagen Co Unipessoal Lda. Therapeutic indication Treatment of osteoporosis. More…, Positive opinions for medicines intended for use outside EU, Acoziborole Winthrop International non-proprietary name (INN) acoziborole  Marketing authorisation applicant Sanofi Winthrop Industrie  Therapeutic…, Negative recommendation on new medicines, Daybu INN trofinetide Marketing authorisation holder Acadia Pharmaceuticals (Netherlands) B.V. Orphan designation This medicine was designated an orphan…, Iloperidone Vanda Pharmaceuticals INN iloperidone  Marketing authorisation holder Vanda Pharmaceuticals Netherlands B.V. More information Iloperidone…, Positive recommendations on extensions of therapeutic indications , Dupixent INN dupilumab  Marketing authorisation holder Sanofi Winthrop Industrie More information Dupixent : pending EC decision, Jorveza INN budesonide  Market authorisation holder Dr. Falk Pharma GmbH More information Jorveza : pending EC decision, Keytruda INN pembrolizumab Market authorisation holder Merck Sharp & Dohme B.V. More information Keytruda : pending EC decision, Olumiant INN baricitinib Market authorisation holder Eli Lilly Nederland B.V. More information Olumiant : pending EC decision, Scemblix INN asciminib Market authorisation holder Novartis Europharm Limited More information Scemblix : pending EC decision, Stelara INN ustekinumab Market authorisation holder Janssen-Cilag International NV More information Stelara : pending EC decision, Withdrawals of initial marketing authorisation application, Zumrad INN sasanlimab  Marketing authorisation applicant Pfizer Europe MA EEIG More information Zumrad : pending EC decision

Published: Feb 27, 2026 | Category: EMA | Name: EMA News

New medicine to treat paediatric low-grade glioma

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Ojemda (tovorafenib) to treat patients aged 6 months and older with paediatric…

Published: Feb 27, 2026 | Category: EMA | Name: EMA News

Minutes of the Management Board meeting: 17-18 December 2025

Published: Feb 26, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Cancer Medicines Forum: December 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 2 December 2025, 16:00 (CET) to 2 December 2025, 17:00 (CET)

Published: Feb 25, 2026 | Category: EMA | Name: EMA Events

Agenda - Webinar on the use of platform approaches in the non-clinical and clinical domains

Published: Feb 24, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - PDCO agenda of the 24-27 February 2026 meeting

Published: Feb 24, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Electronic application form (eAF) Q&A clinic, Online, European Medicines Agency, Amsterdam, the Netherlands, from 9 March 2026, 10:00 (CET) to 9 March 2026, 11:00 (CET)

Published: Feb 23, 2026 | Category: EMA | Name: EMA Events

Agenda of the CHMP meeting 23-26 February 2026

Published: Feb 23, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Annex to agenda of the CHMP meeting 23-26 February 2026

Published: Feb 23, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 January 2026, European Medicines Agency, Amsterdam, the Netherlands, from 13 January 2026 to 15 January 2026

Published: Feb 20, 2026 | Category: EMA | Name: EMA Events

Minutes of the CVMP meeting 13-15 January 2026

Published: Feb 20, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CVMP meeting 2-4 December 2025

Published: Feb 20, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Question and answer on the information contained within section 5.1 of the summary of product characteristics on pharmacodynamic properties for pharmaceutical products

Published: Feb 20, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Recruitment procedure opens for next Executive Director of the European Medicines Agency

The vacancy notice for the next EMA Executive Director has been published in the Official Journal of the European Union, marking the beginning of the recruitment process for the…

Published: Feb 20, 2026 | Category: EMA | Name: EMA News

Draft guideline on quality aspects of mRNA vaccines for veterinary use

Published: Feb 20, 2026 | Category: EMA | Name: EMA Public Consultations

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026

Published: Feb 19, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Committee for Advanced Therapies (CAT): 18-20 February 2026, European Medicines Agency, Amsterdam, the Netherlands, from 18 February 2026 to 20 February 2026

Published: Feb 18, 2026 | Category: EMA | Name: EMA Events

Agenda of the CAT meeting 18-20 February 2026

Published: Feb 18, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - Medicine Shortages SPOC Working Party meeting 17 February 2026

Published: Feb 17, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CHMP meeting 19-22 May 2025

Published: Feb 16, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Committee for Orphan Medicinal Products (COMP): 17-19 February 2026, European Medicines Agency, Amsterdam, the Netherlands, from 17 February 2026 to 19 February 2026

Published: Feb 16, 2026 | Category: EMA | Name: EMA Events

HMA-EMA joint Network Data Steering Group meeting - 13 January 2026

Published: Feb 16, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes - HMA-EMA joint Network Data Steering Group meeting - 13 January 2026

Published: Feb 16, 2026 | Category: EMA | Name: EMA Agenda and Minutes

PDCO minutes of the 9-12 December 2025 meeting

Published: Feb 16, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Draft European Union herbal monograph on Ribes nigrum L., folium - Revision 2

Published: Feb 16, 2026 | Category: EMA | Name: EMA Public Consultations

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 February 2026

CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion for a marketing authorisation for Emepax (maropitant), indicated for the …

Published: Feb 13, 2026 | Category: EMA | Name: EMA News

Concept paper for the revision of the guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management (EMA/522332/2021)

Published: Feb 13, 2026 | Category: EMA | Name: EMA Public Consultations

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 February 2026

PRAC recommends withdrawal of marketing authorisations for levamisole medicinesLeukoencephalopathy confirmed as a serious side effect of levamisoleEMA’s safety committee, the…, Agenda Agenda of the PRAC meeting 9-12 February 2026Draft Reference…, PRAC statistics: February 2026 , PRAC statistics: February 2026 English (EN) (172.98 KB - PDF)First…, Concluded referrals Levamisole-containing medicinal products, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association…

Published: Feb 13, 2026 | Category: EMA | Name: EMA News

EMA recommends withdrawal of marketing authorisations for levamisole medicines

EMA’s safety committee (PRAC) recommended that medicines containing levamisole be withdrawn from the EU market. This follows an EU-wide review which concluded that the benefits…

Published: Feb 13, 2026 | Category: EMA | Name: EMA News

Concept paper on the need of a guideline on clinical investigation of medicinal products in the treatment of Myasthenia Gravis

Published: Feb 13, 2026 | Category: EMA | Name: EMA Public Consultations

Q&A clinic on Substance, Organisation, Referentials Management Services - March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 March 2026, 11:00 (CET) to 10 March 2026, 12:00 (CET)

Q&A clinic on Substance, Organisation, Referentials Management Services - March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 March 2026, 11:00 (CET) to 10 March 2026, 12:00 (CET)

Published: Feb 12, 2026 | Category: EMA | Name: EMA Events

Guidance for applicants for the preparation of the precise scope section of the variation application form

Published: Feb 12, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 March 2026, 15:00 (CET) to 12 March 2026, 16:00 (CET)

Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 March 2026, 15:00 (CET) to 12 March 2026, 16:00 (CET)

Published: Feb 12, 2026 | Category: EMA | Name: EMA Events

16th Industry Standing Group (ISG) meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 31 March 2026, 13:00 (CEST) to 31 March 2026, 17:30 (CEST)

Published: Feb 12, 2026 | Category: EMA | Name: EMA Events

Minutes of the PRAC meeting 24 - 27 November 2025

Published: Feb 12, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Committee for Medicinal Products for Human Use (CHMP): 21-24 July 2025, European Medicines Agency, Amsterdam, the Netherlands, from 21 July 2025 to 24 July 2025

Published: Feb 11, 2026 | Category: EMA | Name: EMA Events

Annex to 21-24 July 2025 CHMP Minutes

Published: Feb 11, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CHMP meeting 21-24 July 2025

Published: Feb 11, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes - 2025 annual internal meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (EnprEMA)

Published: Feb 11, 2026 | Category: EMA | Name: EMA Agenda and Minutes

ICH M15 Guideline on general principles for model-informed drug development - Step 5

Published: Feb 11, 2026 | Category: EMA | Name: EMA Scientific Guidelines

Agenda of the CVMP meeting 10-12 February 2026

Published: Feb 10, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Annex to 16-19 June 2025 CHMP Minutes

Published: Feb 10, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CHMP meeting 16-19 June 2025

Published: Feb 10, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Validation checklist for Type II quality variations

Published: Feb 10, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Agenda of the PRAC meeting 9-12 February 2026

Published: Feb 9, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the COMP meeting 2-3 December 2025

Published: Feb 9, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation

Published: Feb 9, 2026 | Category: EMA | Name: EMA Public Consultations

Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk - with tracked changes

Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk - with tracked changes

Published: Feb 6, 2026 | Category: EMA | Name: EMA Scientific Guidelines

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final considerations on pregnant and breastfeeding women and their children exposed in utero or via breastmilk

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final considerations on pregnant and breastfeeding women and their children exposed in utero or via breastmilk

Published: Feb 6, 2026 | Category: EMA | Name: EMA Scientific Guidelines

Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk

Published: Feb 6, 2026 | Category: EMA | Name: EMA Scientific Guidelines

Highlights – 1st European Medicine Agency (EMA) and European Respiratory Society (ERS) bilateral meeting

Published: Feb 6, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - Combination products operational group, In vitro diagnostics (IVD) stream, 9 February 2026

Published: Feb 6, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - Combination products operational group, Medical devices (MD) stream, 12 February 2026

Published: Feb 6, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Webinar on the use of platform approaches in the non-clinical and clinical domains, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 2 March 2026, 09:25 (CET) to 2 March 2026, 12:30 (CET)

Webinar on the use of platform approaches in the non-clinical and clinical domains, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 2 March 2026, 09:25 (CET) to 2 March 2026, 12:30 (CET)

Published: Feb 6, 2026 | Category: EMA | Name: EMA Events

LinkedIn Live: How EMA supports innovation in medicine development, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 February 2026, 14:30 (CET) to 25 February 2026, 15:00 (CET)

LinkedIn Live: How EMA supports innovation in medicine development, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 February 2026, 14:30 (CET) to 25 February 2026, 15:00 (CET)

Published: Feb 6, 2026 | Category: EMA | Name: EMA Events

Committee for Advanced Therapies (CAT): 3-5 December 2025, European Medicines Agency, Amsterdam, the Netherlands, from 3 December 2025 to 5 December 2025

Published: Feb 5, 2026 | Category: EMA | Name: EMA Events

Third European Medicines Agency (EMA) and IPFA - PPTA global bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 9 February 2026

Published: Feb 5, 2026 | Category: EMA | Name: EMA Events

European Medicines Regulatory Network (EMRN) workshop on Geographic Atrophy endpoints, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, 29 April 2026

Published: Feb 4, 2026 | Category: EMA | Name: EMA Events

Plasma Master File (PMF) requirements - questions and answers for PMF holders

Published: Feb 4, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Minutes – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 17 December 2025

Published: Feb 2, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Recommended submission dates for veterinary medicinal products

Published: Feb 2, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Validation checklist for Type II (non) clinical variations

Published: Jan 30, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Concept paper for the development of a reflection paper on the use of Bayesian methods in clinical development

Published: Jan 30, 2026 | Category: EMA | Name: EMA Public Consultations

Concept paper on the revision of the guideline on clinical evaluation of diagnostic agents and its appendix 1 on imaging agents

Published: Jan 30, 2026 | Category: EMA | Name: EMA Public Consultations

Agenda - PCWP and HCPWP joint meeting February 2026

Published: Jan 30, 2026 | Category: EMA | Name: EMA Agenda and Minutes

First treatment for rare thymidine kinase 2 deficiency

EMA has recommended granting a marketing authorisation in the European Union for Kygevvi (doxecitine and doxribtimine) in patients with genetically confirmed thymidine kinase 2…

Published: Jan 30, 2026 | Category: EMA | Name: EMA News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 26-29 January 2026

Six new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended six medicines for approval at its January 2026 meeting.The committee recommended…, CHMP statistics Key figures from the January 2026 CHMP meeting are represented in the graphic below. , CHMP statistics:…, Positive recommendations on new medicines, Fylrevy International non-proprietary name (INN) estetrol Marketing authorisation applicant Gedeon Richter Plc. Therapeutic indication Hormone replacement…, Ilumira INN lutetium (177Lu) chloride  Marketing authorisation applicant SHINE Europe B.V. Therapeutic indication Used only for the radiolabelling of…, Kayshild INN semaglutide Marketing authorisation applicant Novo Nordisk A/S Therapeutic indication Treatment of non-cirrhotic metabolic dysfunction-associated…, Kygevvi INN doxecitine / doxribtimine Marketing authorisation applicant UCB Pharma Therapeutic indication Treatment of paediatric and adult patients with…, Supemtek INN trivalent influenza vaccine (recombinant, prepared in cell culture) Marketing authorisation applicant Sanofi Winthrop Industrie Therapeutic…, Positive recommendations on extensions of therapeutic indications , Akeega INN niraparib / abiraterone acetate Marketing authorisation holder Janssen Cilag International More information Akeega: pending EC decision, Efmody INN hydrocortisone Marketing authorisation holder Neurocrine Netherlands B.V. More information Efmody: pending EC decision, Eurneffy INN epinephrine Market authorisation holder Alk-Abello A/S More information Eurneffy: pending EC decision, Iclusig INN ponatinib Marketing authorisation holder Incyte Biosciences Distribution B.V. More information Iclusig: pending EC decision, Imfinzi INN durvalumab Marketing authorisation holder AstraZeneca AB More information Imfinzi: pending EC decision, Kerendia INN finerenone Marketing authorisation holder Bayer AG More information Kerendia: pending EC decision, Noxafil INN posaconazole Marketing authorisation holder Merck Sharp and Dohme B.V. More information Noxafil: pending EC decision, Opdivo INN nivolumab Marketing authorisation holder Bristol-Myers Squibb Pharma EEIG More information Opdivo: pending EC decision, Zynyz INN retifanlimab Marketing authorisation holder Incyte Biosciences Distribution B.V. Orphan designation This medicine was designated an orphan medicine…, Outcome of re-examination on recommendation for new medicine, Rezurock INN belumosudil Marketing authorisation applicant Sanofi Winthrop Industrie Orphan designation This medicine was designated an orphan medicine.…, Start of referral procedure, Tavneos INN avacopan More information Tavneos: Article 20 procedure News announcement EMA starts review of Tavneos, a medicine for rare autoimmune diseases…, Other updates, Mounjaro INN tirzepatide Marketing authorisation holder Eli Lilly Nederland B.V. More information Mounjaro, Questions and answers on the outcome of assessment on use of Mounjaro in treatment of heart…

Published: Jan 30, 2026 | Category: EMA | Name: EMA News

First immunotherapy-based treatment recommended for advanced anal cancer

EMA has recommended extending the therapeutic indication of Zynyz (retifanlimab) to include treatment of adults with squamous cell carcinoma of the anal canal (SCAC) that cannot…

Published: Jan 30, 2026 | Category: EMA | Name: EMA News

HMA-EMA joint Network Data Steering Group meeting - 8 December 2025

Published: Jan 28, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the HMPC meeting 17-19 November 2025

Published: Jan 28, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Paediatric Committee (PDCO): 27-30 January 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 27 January 2026 to 30 January 2026

Published: Jan 27, 2026 | Category: EMA | Name: EMA Events

Agenda - PDCO agenda of the 27-30 January 2026 meeting

Published: Jan 27, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Quarterly System Demo - Q1 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 26 March 2026, 09:00 (CET) to 26 March 2026, 12:30 (CET)

Published: Jan 27, 2026 | Category: EMA | Name: EMA Events

Quarterly System Demo - Q2 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 June 2026, 09:00 (CEST) to 25 June 2026, 12:30 (CEST)

Published: Jan 27, 2026 | Category: EMA | Name: EMA Events

Minutes of the CAT meeting 5-7 November 2025

Published: Jan 27, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - February 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 February 2026, 15:00 (CET) to 23 February 2026, 17:00 (CET)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - February 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 February 2026, 15:00 (CET) to 23 February 2026, 17:00 (CET)

Published: Jan 26, 2026 | Category: EMA | Name: EMA Events

Annex to agenda of the CHMP meeting 26-29 January 2026

Published: Jan 26, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the CHMP meeting 26-29 January 2026

Published: Jan 26, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - Webinar on the use of platform technologies in the non-clinical and clinical domains

Published: Jan 26, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Ilona Reischl re-elected as chair of Committee for Advanced Therapies

At its January meeting, EMA’s Committee for Advanced Therapies (CAT) re-elected…, "I am honoured by my colleagues’ continued confidence through my re election as chair of the CAT. The coming period will be one of important evolution as we prepare…, The main role of the CAT is to evaluate applications for ATMPs submitted to EMA and draft an opinion, before the Committee for Medicinal Products for Human…

Published: Jan 23, 2026 | Category: EMA | Name: EMA News

Concept paper on the development of a guideline for using owner assessment as efficacy parameter

Published: Jan 23, 2026 | Category: EMA | Name: EMA Public Consultations

Draft guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees - Revision 2

Published: Jan 23, 2026 | Category: EMA | Name: EMA Public Consultations

Draft guideline for the evaluation of efficacy of ectoparasiticides - general requirements

Published: Jan 23, 2026 | Category: EMA | Name: EMA Public Consultations

Draft guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs) - Revision 1

Published: Jan 23, 2026 | Category: EMA | Name: EMA Public Consultations

Reflection paper on investigation and assessment of cardiovascular safety of anticancer medicinal products

Published: Jan 23, 2026 | Category: EMA | Name: EMA Public Consultations

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 20 January 2026, 09:30 (CET) to 20 January 2026, 13:00 (CET)

Published: Jan 21, 2026 | Category: EMA | Name: EMA Events

EU reference instances (EDQM revision)

Published: Jan 21, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Clinical Trials Information System (CTIS): Walk-in clinic February 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 February 2026, 16:00 (CET) to 18 February 2026, 17:00 (CET)

Clinical Trials Information System (CTIS): Walk-in clinic February 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 February 2026, 16:00 (CET) to 18 February 2026, 17:00 (CET)

Published: Jan 21, 2026 | Category: EMA | Name: EMA Events

Carmen Purdel elected as new chair of the Committee for Herbal Medicinal Products

At its January meeting, EMA’s Committee for Herbal Medicinal Products…, “The HMPC, through its high-quality scientific recommendations, plays a vital role in harmonising the regulation of herbal medicinal products and substance in the EU. A…, The HMPC is the committee responsible for compiling and assessing scientific data on herbal substances, preparations and combinations, to support the harmonisation of…

Published: Jan 21, 2026 | Category: EMA | Name: EMA News

EMA Veterinary Medicines Info Day 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 12 March 2026, 14:00 (CET) to 13 March 2026, 12:30 (CET)

Published: Jan 20, 2026 | Category: EMA | Name: EMA Events

Agenda of the CAT meeting 21-23 January 2026

Published: Jan 20, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Committee for Advanced Therapies (CAT): 21-23 January 2026, European Medicines Agency, Amsterdam, the Netherlands, from 21 January 2026 to 23 January 2026

Published: Jan 20, 2026 | Category: EMA | Name: EMA Events

Agenda of the COMP meeting 20-22 January 2026

Published: Jan 20, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Veterinary medicines in 2025

EMA has published an overview of its key recommendations of 2025 regarding the authorisation and safety monitoring of veterinary medicines.In 2025, EMA recommended 30…

Published: Jan 19, 2026 | Category: EMA | Name: EMA News

Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications 2026-2027

Published: Jan 19, 2026 | Category: EMA | Name: EMA Procedural Guidelines

Agenda of the HMPC meeting 19-21 January 2026

Published: Jan 19, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 January 2026

CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion on a marketing authorisation from Elanco for Lotilaner / Milbemycin Elanco (…

Published: Jan 16, 2026 | Category: EMA | Name: EMA News

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12 - 15 January 2026

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines:…, Agenda Agenda of the PRAC meeting 12 - 15 January 2026Draft…, PRAC statistics: January 2026 , PRAC statistics: January 2026 English (EN) (297.63 KB - PDF)First…, Ongoing referrals ProcedureLevamisole-containing medicinal products, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association…

Published: Jan 16, 2026 | Category: EMA | Name: EMA News

Meeting of the CTTI/FDA Patient Engagement Collaborative (PEC) and EMA Patients and Consumers Working Party (PCWP), Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 June 2025, 15:00 (CEST) to 12 June 2025, 17:30 (CEST)

Meeting of the CTTI/FDA Patient Engagement Collaborative (PEC) and EMA Patients and Consumers Working Party (PCWP), Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 June 2025, 15:00 (CEST) to 12 June 2025, 17:30 (CEST)

Published: Jan 16, 2026 | Category: EMA | Name: EMA Events

Meeting of the CTTI/FDA Patient Engagement Collaborative (PEC) and EMA Patients and Consumers Working Party (PCWP), Online, European Medicines Agency, Amsterdam, the Netherlands, from 18 June 2024, 15:00 (CEST) to 18 June 2024, 17:30 (CEST)

Meeting of the CTTI/FDA Patient Engagement Collaborative (PEC) and EMA Patients and Consumers Working Party (PCWP), Online, European Medicines Agency, Amsterdam, the Netherlands, from 18 June 2024, 15:00 (CEST) to 18 June 2024, 17:30 (CEST)

Published: Jan 16, 2026 | Category: EMA | Name: EMA Events

Meeting of the CTTI/FDA Patient Engagement Collaborative (PEC) and EMA Patients and Consumers Working Party (PCWP), Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 July 2023, 15:00 (CEST) to 20 July 2023, 17:00 (CEST)

Meeting of the CTTI/FDA Patient Engagement Collaborative (PEC) and EMA Patients and Consumers Working Party (PCWP), Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 July 2023, 15:00 (CEST) to 20 July 2023, 17:00 (CEST)

Published: Jan 16, 2026 | Category: EMA | Name: EMA Events

Webinar on the use of platform technologies in the non-clinical and clinical domains, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 2 March 2026, 09:25 (CET) to 2 March 2026, 12:15 (CET)

Webinar on the use of platform technologies in the non-clinical and clinical domains, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 2 March 2026, 09:25 (CET) to 2 March 2026, 12:15 (CET)

Published: Jan 15, 2026 | Category: EMA | Name: EMA Events

Paediatric Committee (PDCO): 11-14 November 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 November 2025 to 14 November 2025

Published: Jan 15, 2026 | Category: EMA | Name: EMA Events

Minutes - PDCO minutes of the 11-14 November 2025 meeting

Published: Jan 15, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the COMP meeting 4-6 November 2025

Published: Jan 15, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Human medicines in 2025

In 2025, EMA recommended 104 medicines for marketing authorisation. Of these, 38 had a new active substance which had never been authorised in the European Union (EU) before.…

Published: Jan 15, 2026 | Category: EMA | Name: EMA News

EMA and FDA set common principles for AI in medicine development

EMA and the U.S. Food and Drug Administration (FDA) have jointly identified ten principles for good artificial intelligence (AI) practice in the medicines lifecycle.The…, "The guiding principles of good AI practice in drug development are a first step of a renewed EU-US cooperation in the field of novel medical technologies. The…, The use of AI technologies across the medicines lifecycle has increased significantly in recent years. As emphasised in the European Commission’s Biotech Act proposal, AI holds…

Published: Jan 14, 2026 | Category: EMA | Name: EMA News

Agenda of the CVMP meeting 13-15 January 2026

Published: Jan 12, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Pharmacovigilance Risk Assessment Committee (PRAC): 12 - 15 January 2026, European Medicines Agency, Amsterdam, the Netherlands, from 12 January 2026 to 15 January 2026

Published: Jan 12, 2026 | Category: EMA | Name: EMA Events

Agenda of the PRAC meeting 12 - 15 January 2026

Published: Jan 12, 2026 | Category: EMA | Name: EMA Agenda and Minutes

Product Management Service (PMS) information day 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 9 June 2026, 09:00 (CEST) to 9 June 2026, 13:00 (CEST)

Published: Jan 12, 2026 | Category: EMA | Name: EMA Events

Q&A clinic on Substance, Organisation, Referentials Management Services, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 15 December 2025, 11:00 (CET) to 15 December 2025, 12:00 (CET)

Q&A clinic on Substance, Organisation, Referentials Management Services, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 15 December 2025, 11:00 (CET) to 15 December 2025, 12:00 (CET)

Published: Jan 12, 2026 | Category: EMA | Name: EMA Events

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - December 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 December 2025, 11:

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - December 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 December 2025, 11:00 (CET) to 18 December 2025, 12:00 (CET)

Published: Jan 12, 2026 | Category: EMA | Name: EMA Events

Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 December 2025, 14:00 (CET) to 18 December 2025, 15:00 (CET)

Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 December 2025, 14:00 (CET) to 18 December 2025, 15:00 (CET)

Published: Jan 12, 2026 | Category: EMA | Name: EMA Events

Healthcare Professionals' Working Party (HCPWP) plenary meeting February 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, 3 February 2026

Published: Jan 9, 2026 | Category: EMA | Name: EMA Events

Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting, European Medicines Agency, Amsterdam, the Netherlands, from 3 February 2026 to 4 February 2026

Published: Jan 8, 2026 | Category: EMA | Name: EMA Events

EMA press briefing on human medicines in 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 15 January 2026, 14:00 (CET) to 15 January 2026, 14:45 (CET)

Published: Jan 7, 2026 | Category: EMA | Name: EMA Events

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - January 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 28 January 2026, 13:00 (CET) to 28 January 2026, 15:00 (CET)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - January 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 28 January 2026, 13:00 (CET) to 28 January 2026, 15:00 (CET)

Published: Jan 6, 2026 | Category: EMA | Name: EMA Events

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 March 2026, 10:00 (CET) to 23 March 2026, 12:00 (CET)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 March 2026, 10:00 (CET) to 23 March 2026, 12:00 (CET)

Published: Jan 6, 2026 | Category: EMA | Name: EMA Events

Second webinar on new approach methodologies (NAMs) in ecotoxicology: Gill cell line assay for acute fish toxicity prediction, Online, from 28 January 2026, 14:00 (CET) to 28 January 2026, 15:30 (CET)

Second webinar on new approach methodologies (NAMs) in ecotoxicology: Gill cell line assay for acute fish toxicity prediction, Online, from 28 January 2026, 14:00 (CET) to 28 January 2026, 15:30 (CET)

Published: Jan 5, 2026 | Category: EMA | Name: EMA Events

HMA-EMA joint Network Data Steering Group meeting - 6 November 2025

Published: Dec 22, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Emer Cooke, EMA’s Executive Director: 2025 achievements in medicine regulation

2025 was a special year for EMA, its staff and the whole European Medicine…, Second, we will intensify our support for innovation for public and animal health. We will further enhance our early development support to enable new medicines to be…

Published: Dec 19, 2025 | Category: EMA | Name: EMA News

EMA Management Board: highlights of December 2025 meeting

The Management Board opened its meeting welcoming the political agreement reached by the European Commission, the European Parliament and the Council of the European Union…

Published: Dec 19, 2025 | Category: EMA | Name: EMA News

EMA business hours over holiday period

EMA's office is closed from 18:00 on Monday 22 December 2025 to 08:30 on Monday 5 January 2026.Outside of working hours and on public holidays, it is possible to call our…

Published: Dec 19, 2025 | Category: EMA | Name: EMA News

Minutes of the PRAC meeting 27 - 30 October 2025

Published: Dec 18, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 20 November 2025

Published: Dec 18, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - Management Board meeting: 17-18 December 2025

Published: Dec 17, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Meeting on the impact of chemical and environmental policies on the healthcare sector and availability of medicines, European Medicines Agency, Amsterdam, the Netherlands, 19 December 2025

Published: Dec 17, 2025 | Category: EMA | Name: EMA Events

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - March 2026, Online, from 11 March 2026, 09:00 (CET) to 13 March 2026, 13:30 (CET)

Published: Dec 17, 2025 | Category: EMA | Name: EMA Events

Q&A Clinic - New Variation Classification in eAF , Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 January 2026, 10:00 (CET) to 8 January 2026, 11:00 (CET)

Published: Dec 16, 2025 | Category: EMA | Name: EMA Events

Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals

Published: Dec 15, 2025 | Category: EMA | Name: EMA Public Consultations

Minutes of the CVMP meeting 4-6 November 2025

Published: Dec 12, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Clinical Trials Information System (CTIS) sponsor end user training programme - March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 9 March 2026, 09:00 (CET) to 12 March 2026, 13:30 (CET)

Clinical Trials Information System (CTIS) sponsor end user training programme - March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 9 March 2026, 09:00 (CET) to 12 March 2026, 13:30 (CET)

Published: Dec 12, 2025 | Category: EMA | Name: EMA Events

EMA multi-stakeholder workshop on supporting innovation in cardiovascular medicines and medical devices in the EU, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 1 July 2026, 13:00 (CEST) to 2 July 2026, 16:00 (CEST)

EMA multi-stakeholder workshop on supporting innovation in cardiovascular medicines and medical devices in the EU, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 1 July 2026, 13:00 (CEST) to 2 July 2026, 16:00 (CEST)

Published: Dec 12, 2025 | Category: EMA | Name: EMA Events

EMA multistakeholder workshop on supporting innovation in cardiovascular medicines and medical devices in the EU, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 1 July 2026 to 2 July 2026

EMA multistakeholder workshop on supporting innovation in cardiovascular medicines and medical devices in the EU, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 1 July 2026 to 2 July 2026

Published: Dec 12, 2025 | Category: EMA | Name: EMA Events

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 December 2025

Seven new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2025 meeting.The committee…, CHMP statistics Key figures from the December 2025 CHMP meeting are represented in the graphic below. , CHMP statistics:…, Positive recommendations on new medicines, Anktiva International non-proprietary name (INN) nogapendekin alfa inbakicept  Marketing authorisation applicant Serum Life Science Europe GmbH…, Aumseqa INN aumolertinib  Marketing authorisation applicant SFL Pharmaceuticals Deutschland GmbH Therapeutic indication Treatment of non-small cell lung…, Exdensur INN depemokimab  Marketing authorisation applicant Glaxosmithkline Trading Services Limited Therapeutic indication For severe eosinophilic…, Myqorzo INN aficamten  Marketing authorisation applicant Cytokinetics (Ireland) Limited Therapeutic indication Treatment of symptomatic obstructive…, mNexspike INN COVID-19 mRNA vaccine Marketing authorisation applicant Moderna Biotech Spain S.L. Therapeutic indication Active immunisation to prevent COVID…, Positive recommendations on new biosimilar medicines, Gotenfia INN golimumab  Marketing authorisation applicant STADA Arzneimittel AG Therapeutic indication Treatment of rheumatoid arthritis, juvenile…, Ranluspec INN ranibizumab Marketing authorisation applicant Lupin Europe GmbH Therapeutic indication Treatment of neovascular (wet) age-related macular…, Negative recommendation on new medicine, Blarcamesine Anavex INN blarcamesine  Marketing authorisation applicant Anavex Germany GmbH Therapeutic indication Treatment of Alzheimer’s disease and…, Positive recommendations on extensions of therapeutic indications , Arexvy Common name respiratory syncytial virus (RSV) vaccine (recombinant, adjuvanted) Market authorisation holder GlaxoSmithKline Biologicals More information…, Aspaveli INN pegcetacoplan  Marketing authorisation holder Swedish Orphan Biovitrum AB  More information Aspaveli: pending EC decision, Dovprela INN pretomanid  Marketing authorisation holder Mylan IRE Healthcare Limited More information Dovprela: pending EC decision, Elucirem INN gadopiclenol  Marketing authorisation holder Guerbet More information Elucirem: pending EC decision, Eylea INN aflibercept Marketing authorisation holder Bayer AG More information Eylea: pending EC decision, Mounjaro INN tirzepatide  Marketing authorisation holder Eli Lilly Nederland B.V More information Mounjaro: pending EC decision, Nucala INN mepolizumab  Marketing authorisation holder Glaxosmithkline Trading Services Limited More information Nucala: pending EC decision, Recarbrio INN imipenem / cilastatin / relebactam Marketing authorisation holder Merck Sharp & Dohme B.V.  More information Recarbrio: pending EC…, Simponi INN golimumab Marketing authorisation holder Janssen Cilag International More information Simponi: pending EC decision, Uplizna INN inebilizumab  Marketing authorisation holder Amgen Europe B.V More information Uplizna: pending EC decision, Vueway INN gadopiclenol Marketing authorisation holder Bracco Imaging S.p.A More information Vueway: pending EC decision, Winrevair INN sotatercept  Marketing authorisation holder Merck Sharp & Dohme B.V More information Winrevair: pending EC decision, Withdrawal of initial marketing authorisation application, Jelrix INN autologous cartilage-derived articular chondrocytes, in-vitro expanded Marketing authorisation applicant TETEC Tissue Engineering Technologies AG…, Negative recommendation on extension of therapeutic indications, Hetlioz INN tasimelteon Orphan designation This medicine was designated an orphan medicine. More information Hetlioz: pending EC decision, Article 29(4) referral Melatomed and associated names, Other updates, Vfend INN voriconazole Marketing authorisation holder Pfizer Europe MA EEIG More information Vfend: pending EC decision

Published: Dec 12, 2025 | Category: EMA | Name: EMA News

New medicine to treat non-muscle invasive bladder cancer

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Anktiva (nogapendekin alfa inbakicept) to treat adults with a type of…

Published: Dec 12, 2025 | Category: EMA | Name: EMA News

Guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2

Published: Dec 12, 2025 | Category: EMA | Name: EMA Scientific Guidelines

ICH E22 Guideline on general considerations for patient preference studies - Step 2b

Published: Dec 12, 2025 | Category: EMA | Name: EMA Public Consultations

Checklist for the submission of Day 215 product information annexes for a post-opinion linguistic review (Word file)

Published: Dec 12, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Guideline on stability testing for applications for variations to a marketing authorisation - Revision 3

Published: Dec 12, 2025 | Category: EMA | Name: EMA Scientific Guidelines

New variations guidelines: webinar for marketing authorisation holders (human), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 13 January 2026, 13:00 (CET) to 13 January 2026, 15:00 (CET)

New variations guidelines: webinar for marketing authorisation holders (human), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 13 January 2026, 13:00 (CET) to 13 January 2026, 15:00 (CET)

Published: Dec 11, 2025 | Category: EMA | Name: EMA Events

Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - February 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 February 2026, 09:00 (CET) to 12 February 2026, 13:30 (CET)

Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - February 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 February 2026, 09:00 (CET) to 12 February 2026, 13:30 (CET)

Published: Dec 11, 2025 | Category: EMA | Name: EMA Events

EMA welcomes political agreement on new EU pharmaceutical legislation

EMA welcomes the landmark political agreement reached by the European Commission, the European Parliament and the Council of the European Union on the comprehensive reform of…, Today marks a historic milestone for European medicines regulation and for patients across the EU. The revamp of the pharmaceutical legislation will enable EMA and the…, The new legislation will modernise how medicines are developed, authorised and made available to patients across the EU. It is expected to simplify structures and…

Published: Dec 11, 2025 | Category: EMA | Name: EMA News

Agenda – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (17 December 2025)

Published: Dec 11, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Questions and answers on post approval change management protocols (PACMP) - Revision 1

Published: Dec 11, 2025 | Category: EMA | Name: EMA Scientific Guidelines

Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting inthe EU: Hands-on training course using the EudraVigilance System, Online, from 23 February 2026 to 26 February 2026

Published: Dec 11, 2025 | Category: EMA | Name: EMA Events

Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting inthe EU: Hands-on training course using the EudraVigilance System, Online, from 26 January 2026 to 30 January 2026

Published: Dec 11, 2025 | Category: EMA | Name: EMA Events

Draft guideline on quality of radiopharmaceuticals - Revision 2

Published: Dec 10, 2025 | Category: EMA | Name: EMA Public Consultations

EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO)

Published: Dec 10, 2025 | Category: EMA | Name: EMA Procedural Guidelines

2025 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA), Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 November 2025, 13:00 (CET) to 19 November 2025, 17:45 (C

2025 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA), Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 November 2025, 13:00 (CET) to 19 November 2025, 17:45 (CET)

Published: Dec 10, 2025 | Category: EMA | Name: EMA Events

Minutes of the CAT meeting 8-9 October 2025

Published: Dec 10, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CAT meeting 10-12 September 2025

Published: Dec 10, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Meeting summary - PCWP/HCPWP and all eligible organisations meeting 18 November 2025

Published: Dec 9, 2025 | Category: EMA | Name: EMA Agenda and Minutes

List of substances and products subject to worksharing for signal management

Published: Dec 9, 2025 | Category: EMA | Name: EMA Procedural Guidelines

New data on antimicrobials sales and use in animals in the EU

The second European Sales and Use of Antimicrobials for Veterinary Medicine (ESUAvet) annual surveillance report is now published, consolidating data from the EU including…, With ESUAvet, we are not just collecting data - we are building trust, enabling action, and contributing to a healthier future for all. Reliable data support smarter…, Sales data of antimicrobials for food-producing animalsIn 2024, 98% of total sales of antimicrobial VMPs were for food-producing animals. Sales for this group increased by 5%…

Published: Dec 9, 2025 | Category: EMA | Name: EMA News

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 9 December 2025, 09:30 (CET) to 9 December 2025, 13:30 (CET)

Published: Dec 9, 2025 | Category: EMA | Name: EMA Events

Guideline on the development and manufacture of synthetic peptides

Published: Dec 9, 2025 | Category: EMA | Name: EMA Scientific Guidelines

Agenda - PDCO agenda of the 9-12 December 2025 meeting

Published: Dec 8, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Programme - Joint HMA/EMA multi-stakeholder workshop on Patient Registries December 2025

Published: Dec 8, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Committee for Medicinal Products for Human Use (CHMP): 08-11 December 2025, European Medicines Agency, Amsterdam, the Netherlands, from 8 December 2025 to 11 December 2025

Published: Dec 8, 2025 | Category: EMA | Name: EMA Events

Annex to agenda of the CHMP meeting 8-11 December 2025

Published: Dec 8, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the CHMP meeting 8-11 December 2025

Published: Dec 8, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Concept paper on the guideline revision on good pharmacogenomic practice

Published: Dec 8, 2025 | Category: EMA | Name: EMA Public Consultations

Call for user acceptance testers for the read functionality in the Public Product Management Service (PMS) Application Programming Interface (API)

Published: Dec 8, 2025 | Category: EMA | Name: EMA Public Consultations

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 2-4 December 2025

CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion for a marketing authorisation from Elanco GmbH for Varenzin (molidustat), for the…, Maximum residue limits Lidocaine (Porcine) - Summary opinion of the CVMP on the…

Published: Dec 5, 2025 | Category: EMA | Name: EMA News

All languages - Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Revision 5

Published: Dec 5, 2025 | Category: EMA | Name: EMA Scientific Guidelines

Explanatory note on the withdrawal of the interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU

Published: Dec 4, 2025 | Category: EMA | Name: EMA Scientific Guidelines

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - November 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 November 2025, 11:

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - November 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 November 2025, 11:00 (CET) to 18 November 2025, 12:00 (CET)

Published: Dec 3, 2025 | Category: EMA | Name: EMA Events

Classification of changes

Published: Dec 3, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Classification of changes (tracked changes)

Published: Dec 3, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - January 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 15 January 2026, 15:00 (CET) to 15 January 2026, 16:00 (CET)

Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - January 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 15 January 2026, 15:00 (CET) to 15 January 2026, 16:00 (CET)

Published: Dec 3, 2025 | Category: EMA | Name: EMA Events

Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - January 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 January 2026, 15:00 (CET) to 13 January 2026, 16

Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - January 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 January 2026, 15:00 (CET) to 13 January 2026, 16:00 (CET)

Published: Dec 3, 2025 | Category: EMA | Name: EMA Events

HMA-EMA joint Network Data Steering Group meeting - 6 October 2025

Published: Dec 3, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the CAT meeting 3-5 December 2025

Published: Dec 3, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 November 2025, 14:00 (CET) to 18 November 2025, 15:00 (CET)

Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 November 2025, 14:00 (CET) to 18 November 2025, 15:00 (CET)

Published: Dec 2, 2025 | Category: EMA | Name: EMA Events

Committee for Medicinal Products for Veterinary Use (CVMP): 2-4 December 2025, European Medicines Agency, Amsterdam, the Netherlands, from 2 December 2025 to 4 December 2025

Published: Dec 2, 2025 | Category: EMA | Name: EMA Events

Agenda of the CVMP meeting 2-4 December 2025

Published: Dec 2, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Q&A clinic on Substance, Organisation, Referentials Management Services - January 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 January 2026, 11:00 (CET) to 13 January 2026, 12:00 (CET)

Q&A clinic on Substance, Organisation, Referentials Management Services - January 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 January 2026, 11:00 (CET) to 13 January 2026, 12:00 (CET)

Published: Dec 2, 2025 | Category: EMA | Name: EMA Events

SPOR and XEVMPD status update webinar - Q2 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 April 2026, 10:00 (CEST) to 13 April 2026, 12:30 (CEST)

Published: Dec 2, 2025 | Category: EMA | Name: EMA Events

Agenda of the COMP meeting 2-3 December 2025

Published: Dec 2, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Third workshop between notified bodies and expert panels , Online, from 4 December 2025, 17:30 (CET) to 4 December 2025, 18:30 (CET)

Published: Dec 1, 2025 | Category: EMA | Name: EMA Events

Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease

Published: Dec 1, 2025 | Category: EMA | Name: EMA Public Consultations

Minutes - Management Board meeting: 2 October 2025

Published: Dec 1, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Procedural advice for veterinary vaccine antigen master file (VAMF) certification

Published: Nov 28, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Procedural advice for vaccine platform technology master file (vPTMF) certification

Published: Nov 28, 2025 | Category: EMA | Name: EMA Scientific Guidelines

Guidance for stepwise PIPs (sPIPs)

Published: Nov 28, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Orphan designation: carfilzomib Treatment of multiple myeloma, 03/06/2008 Expired

Published: Nov 28, 2025 | Category: EMA | Name: EMA Orphan

Meeting Summary - Medicine Shortages SPOC Working Party 14-15 October 2025

Published: Nov 28, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 - 27 November 2025

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines:…, Agenda Agenda of the PRAC meeting 24 - 27 November 2025Draft…, PRAC statistics: December 2025 , PRAC statistics: December 2025 English (EN) (105.29 KB - PDF)First…, Ongoing referrals ProcedureLevamisole-containing medicinal products, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association…

Published: Nov 28, 2025 | Category: EMA | Name: EMA News

Kick-off meeting of the HMA-EMA group focused on AI with industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 7 November 2025, 09:00 (CET) to 7 November 2025, 10:30 (CET)

Kick-off meeting of the HMA-EMA group focused on AI with industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 7 November 2025, 09:00 (CET) to 7 November 2025, 10:30 (CET)

Published: Nov 28, 2025 | Category: EMA | Name: EMA Events

Eighth European Medicines Agency (EMA) and Medicines for Europe bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 15 December 2025, 15:00 (CET) to 15 December 2025, 17:00 (CET)

Eighth European Medicines Agency (EMA) and Medicines for Europe bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 15 December 2025, 15:00 (CET) to 15 December 2025, 17:00 (CET)

Published: Nov 27, 2025 | Category: EMA | Name: EMA Events

Clinical Trials Information System (CTIS): Walk-in clinic November 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 19 November 2025, 16:00 (CET) to 19 November 2025, 17:00 (CET)

Clinical Trials Information System (CTIS): Walk-in clinic November 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 19 November 2025, 16:00 (CET) to 19 November 2025, 17:00 (CET)

Published: Nov 26, 2025 | Category: EMA | Name: EMA Events

Seventh European Medicines Agency - EuropaBio bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 20 January 2026, 10:00 (CET) to 20 January 2026, 12:00 (CET)

Published: Nov 26, 2025 | Category: EMA | Name: EMA Events

Sixth European Medicines Agency (EMA) and the Association of the European Self-Care Industry (AESGP) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 January 2026, 14:00 (CET) to 23 January 2026, 16:00 (CET)

Sixth European Medicines Agency (EMA) and the Association of the European Self-Care Industry (AESGP) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 January 2026, 14:00 (CET) to 23 January 2026, 16:00 (CET)

Published: Nov 26, 2025 | Category: EMA | Name: EMA Events

DARWIN EU Advisory Board meeting: 20 January 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 January 2025, 09:30 (CET) to 20 January 2025, 10:30 (CET)

Published: Nov 26, 2025 | Category: EMA | Name: EMA Events

Minutes - DARWIN EU Advisory Board - 20 January 2025

Published: Nov 26, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - DARWIN EU Advisory Board - 20 January 2025

Published: Nov 26, 2025 | Category: EMA | Name: EMA Agenda and Minutes

DARWIN EU Advisory Board meeting: 25 November 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 25 November 2024, 09:30 (CET) to 25 November 2024, 11:30 (CET)

Published: Nov 26, 2025 | Category: EMA | Name: EMA Events

Minutes - DARWIN EU Advisory Board - 25 November 2024

Published: Nov 26, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - DARWIN EU Advisory Board - 25 November 2024

Published: Nov 26, 2025 | Category: EMA | Name: EMA Agenda and Minutes

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes

Published: Nov 26, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Cancer Medicines Forum: September 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 4 September 2025, 14:00 (CEST) to 4 September 2025, 17:00 (CEST)

Published: Nov 25, 2025 | Category: EMA | Name: EMA Events

Minutes of the Cancer Medicines Forum - September 2025

Published: Nov 25, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the COMP meeting 7-8 October 2025

Published: Nov 25, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the PRAC meeting 24 - 27 November 2025

Published: Nov 24, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the PRAC meeting 29 September - 2 October 2025

Published: Nov 21, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 20 October 2025

Published: Nov 21, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the HMPC meeting 22-24 September 2025

Published: Nov 21, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Call for expressions of interest for civil society representatives to participate in the work of EMA’s Paediatric Committee

The European Commission has launched a call for expressions of interest to represent patient and healthcare professional organisations in EMA’s Paediatric Committee (PDCO).…

Published: Nov 20, 2025 | Category: EMA | Name: EMA News

EMA - European Consumer Organisation (BEUC) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 10 November 2025

Published: Nov 18, 2025 | Category: EMA | Name: EMA Events

Agenda of the HMPC meeting 17-19 November 2025

Published: Nov 17, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Improved scientific advice for medicines for public health threats including antimicrobial resistance

EMA’s Emergency Task Force (ETF) is improving its approach to scientific advice for the most promising medicines and vaccines under development for public health threats.Under…, “With this new approach, developers will receive clear input on the design of clinical trials to allow generation of adequate evidence, and how these trials should be…, The approach will be crucial to enhance the rapid development and approval of medicines ahead of and during public health emergencies. The overall goal is to ensure alignment…

Published: Nov 17, 2025 | Category: EMA | Name: EMA News

European Medicines Agency (EMA) and European Association for the Study of Diabetes (EASD) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 September 2025, 10:30 (CEST) to 26 September 2025, 12:00 (CEST)

European Medicines Agency (EMA) and European Association for the Study of Diabetes (EASD) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 September 2025, 10:30 (CEST) to 26 September 2025, 12:00 (CEST)

Published: Nov 14, 2025 | Category: EMA | Name: EMA Events

European Medicine Agency (EMA) and European Association for the Study of Diabetes (EASD) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 September 2025, 10:30 (CEST) to 26 September 2025, 12:00 (CEST)

European Medicine Agency (EMA) and European Association for the Study of Diabetes (EASD) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 September 2025, 10:30 (CEST) to 26 September 2025, 12:00 (CEST)

Published: Nov 14, 2025 | Category: EMA | Name: EMA Events

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 November 2025

Ten new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended ten medicines for approval at its November 2025 meeting.The committee recommended…, CHMP statistics , CHMP statistics: Text…, Positive recommendations on new medicines, Dawnzera International non-proprietary name (INN) donidalorsen Marketing authorisation applicant Otsuka Pharmaceutical Netherlands B.V. Therapeutic indication…, GalenVita International non-proprietary name (INN) Germanium (68Ge) chloride / Gallium (68Ga) chloride Marketing authorisation applicant Curium Romania S.R.L.…, Inluriyo International non-proprietary name (INN) imlunestrant Marketing authorisation applicant Eli Lilly Nederland B.V. Therapeutic indication Monotherapy…, Teizeild International non-proprietary name (INN) teplizumab Marketing authorisation applicant Sanofi Winthrop Industrie Therapeutic indication To delay the…, VacPertagen International non-proprietary name (INN) pertussis vaccine (recombinant, acellular, component, adsorbed) Marketing authorisation applicant BioNet…, Waskyra International non-proprietary name (INN) Autologous CD34+ haematopoietic stem cells transduced ex vivo with a lentiviral vector encoding human Wiskott-…, Positive recommendations on new hybrid medicines, Enzalutamide Accordpharma International non-proprietary name (INN) enzalutamide Marketing authorisation applicant Accord Healthcare Therapeutic indication…, Positive recommendations on new biosimilar medicines, Ondibta International non-proprietary name (INN) insulin glargine Marketing authorisation applicant Gan & Lee Pharmaceuticals Europe GmbH Therapeutic…, Osqay International non-proprietary name (INN) denosumab Marketing authorisation applicant Theramex Ireland Limited Therapeutic indication Treatment of…, Positive recommendations on new generic medicines, Teduglutide Viatris International non-proprietary name (INN) teduglutide Marketing authorisation applicant Viatris Limited Therapeutic indication Treatment of…, Positive recommendations on extensions of therapeutic indications , Koselugo International non-proprietary name (INN) selumetinib Marketing authorisation holder AstraZeneca AB Orphan designation This medicine was designated an…, Minjuvi International non-proprietary name (INN) tafasitamab Marketing authorisation applicant Incyte Biosciences Distribution B.V. More information Minjuvi…, Veyvondi International non-proprietary name (INN) vonicog alfa Marketing authorisation holder Baxalta Innovations GmbH More information Veyvondi : pending EC…, Xerava International non-proprietary name (INN) eravacycline Marketing authorisation holder PAION Pharma GmbH More information Xerava : pending EC decision, Negative recommendations on extensions of therapeutic indications, Hetlioz International non-proprietary name (INN) tasimelteon Marketing authorisation holder Vanda Pharmaceuticals Netherlands B.V. More information Hetlioz, Outcome of re-examination on recommendation for new medicine, Aqneursa International non-proprietary name (INN) levacetylleucine Marketing authorisation applicant Intrabio Ireland Limited Therapeutic indication Chronic…, Start of re-examination on recommendation for new medicine, Rezurock International non-proprietary name (INN) belumosudil Marketing authorisation applicant Sanofi Winthrop Industrie Therapeutic indication Treatment of…, Withdrawal of initial marketing authorisation application, Insulin Aspart Injection International non-proprietary name (INN) insulin aspart Market authorisation applicant Masuu Pharma Europe Limited Therapeutic…, Nurzigma International non-proprietary name (INN) pridopidine Market authorisation applicant Prilenia Therapeutics B.V. Therapeutic indication Treatment of…, Ohtuvayre International non-proprietary name (INN) ensifentrine Market authorisation applicant Verona Pharma Ireland Limited Therapeutic indication…

Published: Nov 14, 2025 | Category: EMA | Name: EMA News

European Medicines Agency and Transcelerate bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, 17 November 2025

Published: Nov 14, 2025 | Category: EMA | Name: EMA Events

First-in-class treatment to delay onset of type 1 diabetes

EMA has recommended granting a marketing authorisation in the European Union (EU) for Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes in adults and…

Published: Nov 14, 2025 | Category: EMA | Name: EMA News

Minutes of the CVMP meeting 7-9 October 2025

Published: Nov 14, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Concept paper for the development of a guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in non-food-producing animal species

Concept paper for the development of a guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in non-food-producing animal species

Published: Nov 14, 2025 | Category: EMA | Name: EMA Public Consultations

Questions and answers on classification of a product as intended for a limited market according to Article 4(29) and/or eligibility for authorisation according to Article 23 (Applications for limited markets)

Questions and answers on classification of a product as intended for a limited market according to Article 4(29) and/or eligibility for authorisation according to Article 23 (Applications for limited markets)

Published: Nov 14, 2025 | Category: EMA | Name: EMA Scientific Guidelines

Concept paper on a paediatric update of the guideline on clinical investigation of medicinal products for the management of Crohn’s disease

Published: Nov 13, 2025 | Category: EMA | Name: EMA Public Consultations

Concept paper on a paediatric update on the guideline on the development of new medicinal products for the treatment of Ulcerative Colitis

Published: Nov 13, 2025 | Category: EMA | Name: EMA Public Consultations

Draft guideline on non-inferiority and equivalence comparisons in clinical trials

Published: Nov 13, 2025 | Category: EMA | Name: EMA Public Consultations

HMA/EMA multi-stakeholder workshop on artificial intelligence (AI), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 20 November 2025, 13:00 (CET) to 21 November 2025, 12:00 (CET)

HMA/EMA multi-stakeholder workshop on artificial intelligence (AI), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 20 November 2025, 13:00 (CET) to 21 November 2025, 12:00 (CET)

Published: Nov 12, 2025 | Category: EMA | Name: EMA Events

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 11 November 2025, 09:30 (CET) to 11 November 2025, 13:00 (CET)

Published: Nov 12, 2025 | Category: EMA | Name: EMA Events

Fourth European Medicines Agency (EMA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 8 December 2025, 13:00 (CET) to 8 December 2025, 15:00 (CET)

Fourth European Medicines Agency (EMA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 8 December 2025, 13:00 (CET) to 8 December 2025, 15:00 (CET)

Published: Nov 12, 2025 | Category: EMA | Name: EMA Events

Agenda - PCWP/HCPWP and all eligible organisations meeting 2025

Published: Nov 11, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - PDCO agenda of the 11-14 November 2025 meeting

Published: Nov 11, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Quarterly System Demo - Q4 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 16 December 2025, 09:30 (CET) to 16 December 2025, 12:15 (CET)

Published: Nov 10, 2025 | Category: EMA | Name: EMA Events

Agenda - HMA/EMA Annual Data Forum 2025

Published: Nov 10, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Annex to agenda of the CHMP meeting 10-13 November 2025

Published: Nov 10, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the CHMP meeting 10-13 November 2025

Published: Nov 10, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Orphan designation: Obinutuzumab Treatment of follicular lymphoma, 19/06/2015 Withdrawn

Published: Nov 7, 2025 | Category: EMA | Name: EMA Orphan

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 November 2025

CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion, in exceptional circumstances, for a marketing authorisation for Vaxxinact H5 (Avian…

Published: Nov 7, 2025 | Category: EMA | Name: EMA News

Fifth Veterinary Big Data Stakeholder Forum, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 10 November 2025, 09:00 (CET) to 10 November 2025, 17:30 (CET)

Published: Nov 5, 2025 | Category: EMA | Name: EMA Events

Minutes - PDCO minutes of the 9-12 September 2025 meeting

Published: Nov 5, 2025 | Category: EMA | Name: EMA Agenda and Minutes

15th industry stakeholder platform on research and development support, European Medicines Agency, Amsterdam, the Netherlands, from 4 December 2025, 12:30 (CET) to 4 December 2025, 17:30 (CET)

Published: Nov 4, 2025 | Category: EMA | Name: EMA Events

Committee for Advanced Therapies (CAT): 5-7 November 2025, European Medicines Agency, Amsterdam, the Netherlands, from 5 November 2025 to 7 November 2025

Published: Nov 4, 2025 | Category: EMA | Name: EMA Events

Fourth European Medicines Agency - Medtech Europe bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 21 November 2025

Published: Nov 4, 2025 | Category: EMA | Name: EMA Events

Agenda - 1st EMA and European Respiratory Society (ERS) bilateral meeting

Published: Nov 4, 2025 | Category: EMA | Name: EMA Agenda and Minutes

EMA partners with healthcare professionals and consumers for #ItTakesATeam medicine shortages campaign

EMA, in collaboration with European healthcare professional and consumer organisations, has launched a new awareness campaign on medicine shortages. The #ItTakesATeam campaign…, When patients can’t get a medicine in a pharmacy, their first reaction is distress. While this is legitimate, they are never alone. There are people who are there to…, The campaign was developed jointly with the European Consumer Organisation, the European Association of Hospital Pharmacists, European Association of Nuclear Medicine, the…, The campaign aims to showcase the coordinated system that is needed at EU level to address shortages, but it also represents a step forward in how we engage with…, Through videos, social media messages, and stories from real people involved in addressing shortages, #ItTakesATeam puts a human face on the coordinated efforts to keep…

Published: Nov 4, 2025 | Category: EMA | Name: EMA News

Agenda of the CVMP meeting 4-6 November 2025

Published: Nov 3, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the COMP meeting 4-6 November 2025

Published: Nov 3, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - Public webinar on shortages: putting patients first

Published: Oct 31, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27 - 30 October 2025

New safety information for healthcare professionals  Injectable tranexamic acid: serious adverse reactions when inadvertently given intrathecallyPRAC agreed on a direct…, Agenda Agenda of the PRAC meeting 27 - 30 October 2025Draft…, PRAC statistics: November 2025 , PRAC statistics: November 2025 English (EN) (104.68 KB - PDF)First…, Ongoing referrals ProcedureLevamisole-containing medicinal products, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association…

Published: Oct 31, 2025 | Category: EMA | Name: EMA News

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - October 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 14 October 2025, 11:00

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - October 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 14 October 2025, 11:00 (CEST) to 14 October 2025, 12:00 (CEST)

Published: Oct 29, 2025 | Category: EMA | Name: EMA Events

Agenda - ACT EU multi-stakeholder platform annual meeting - October 2025

Published: Oct 28, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the PRAC meeting 27 - 30 October 2025

Published: Oct 27, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Second European Medicines Agency (EMA) and COCIR bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 7 October 2024

Published: Oct 24, 2025 | Category: EMA | Name: EMA Events

ICMRA Summit 2025: EMA concludes its two mandates as chair

EMA’s Executive Director, Emer Cooke, has handed over the role of chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) to Anthony Lawler from the…, “ICMRA has proven its value both as a platform for sharing information and best practices and as a venue for providing strategic leadership, active exchange of…, At the ICMRA Summit 2025, international medicines authorities addressed the regulators’ role as communicators of reliable, evidence-based, scientific information and the…

Published: Oct 24, 2025 | Category: EMA | Name: EMA News

Minutes of the PRAC meeting 1-4 September 2025

Published: Oct 24, 2025 | Category: EMA | Name: EMA Agenda and Minutes

SPOR and XEVMPD status update webinar - Q1 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 28 January 2026, 10:00 (CET) to 28 January 2026, 12:30 (CET)

Published: Oct 24, 2025 | Category: EMA | Name: EMA Events

Draft qualification opinion for molecule-independent device bridging approach (MIDBA)

Published: Oct 24, 2025 | Category: EMA | Name: EMA Public Consultations

Draft guideline on quality aspects of phage therapy medicinal products

Published: Oct 24, 2025 | Category: EMA | Name: EMA Public Consultations

15th Industry Standing Group (ISG) meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 December 2025, 09:00 (CET) to 11 December 2025, 10:00 (CET)

Published: Oct 23, 2025 | Category: EMA | Name: EMA Events

Minutes of the COMP meeting 9-11 September 2025

Published: Oct 23, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Reflection paper on non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation

Published: Oct 23, 2025 | Category: EMA | Name: EMA Public Consultations

Orphan designation: recombinant human N-acetylgalactosamine-6-sulfatase (elosulfase alfa) Treatment of mucopolysaccharidosis, type IVA (Morquio A syndrome), 24/07/2009 Withdrawn

Published: Oct 23, 2025 | Category: EMA | Name: EMA Orphan

20th industry stakeholder platform - operation of European Union (EU) pharmacovigilance, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 November 2025, 13:30 (CET) to 13 November 2025, 17:40 (CET)

20th industry stakeholder platform - operation of European Union (EU) pharmacovigilance, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 November 2025, 13:30 (CET) to 13 November 2025, 17:40 (CET)

Published: Oct 22, 2025 | Category: EMA | Name: EMA Events

Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (24 September 2025)

Published: Oct 22, 2025 | Category: EMA | Name: EMA Agenda and Minutes

EMA partners with content creators to promote safe and responsible use of GLP-1 medicines

EMA has launched its first social media campaign working with content creators. The #HealthNotHype campaign aims to raise awareness about the safe and responsible use of GLP-1…, “#HealthNotHype is about passing the message that GLP-1 receptor agonists are not magic solutions for weight loss. Like all medicines, they have benefits and risks and…, Partnering with content creatorsThe Agency carefully selected content creators from seven different Member States of the European Union (EU) to ensure a balanced geographical…, CountryChannelFollowers (on 16 October 2025)Finlandjennipuolivali39,000Germanymedicinexcare242,000Italyinfermieregianluca175,000Latviauzlabo32,800…

Published: Oct 21, 2025 | Category: EMA | Name: EMA News

Fifteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 28 November 2025, 09:00 (CET) to 28 November 2025, 13:00 (CET)

Fifteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 28 November 2025, 09:00 (CET) to 28 November 2025, 13:00 (CET)

Published: Oct 20, 2025 | Category: EMA | Name: EMA Events

Orphan designation: 2-(3-(4-(1H-Indazol-5-ylamino)quinazolin-2-yl)phenoxy)-N-isopropylacetamide-methane sulfonic acid salt Treatment of graft-versus-host disease, 17/10/2019 Positive

Published: Oct 17, 2025 | Category: EMA | Name: EMA Orphan

First treatment for serious chronic lung disease

EMA has recommended granting a marketing authorisation in the European Union (EU) for Brinsupri (brensocatib) 25 mg tablets, for the treatment of non-cystic fibrosis…

Published: Oct 17, 2025 | Category: EMA | Name: EMA News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 October 2025

Two new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended two medicines for approval at its October 2025 meeting.The committee recommended…, CHMP statistics , CHMP statistics: Text…, Positive recommendations on new medicines, Brinsupri International non-proprietary name (INN) brensocatib Marketing authorisation applicant Insmed Netherlands B.V. Therapeutic indication Treatment of…, Wayrilz International non-proprietary name (INN) rilzabrutinib Marketing authorisation applicant Sanofi B.V. Therapeutic indication For the treatment of…, Negative recommendation on new medicine, Rezurock INN belumosudil Marketing authorisation applicant Sanofi Winthrop Industrie Therapeutic indication Treatment of chronic graft-versus-host disease (…, Outcome of re-examination on recommendation for new medicine, Austedo INN deutetrabenazine Marketing authorisation applicant Teva GmbH Therapeutic indication Treatment of tardive dyskinesia More information Austedo:…, Positive recommendations on extensions of therapeutic indications , Breyanzi INN lisocabtagene maraleucel / lisocabtagene maraleucel  Marketing authorisation holder Bristol-Myers Squibb Pharma EEIG More information…, Cejemly INN sugemalimab Marketing authorisation holder Cstone Pharmaceuticals Ireland Limited More information Cejemly: pending EC decision, Gazyvaro INN obinutuzumab Marketing authorisation holder Roche Registration GmbH More information Gazyvaro: pending EC decision, Libtayo INN cemiplimab Marketing authorisation holder Regeneron Ireland Designated Activity Company (DAC) More information Libtayo: pending EC decision, Paxlovid INN nirmatrelvir / ritonavir Marketing authorisation holder Pfizer Europe MA EEIG More information Paxlovid: pending EC decision, Pyrukynd INN mitapivat Marketing authorisation holder Agios Netherlands B.V. More information Pyrukynd: pending EC decision, Tremfya INN guselkumab Marketing authorisation holder Janssen Cilag International More information Tremfya: pending EC decision, Scemblix INN asciminib Market authorisation holder Novartis Europharm Limited More information Scemblix: pending EC decision, Withdrawal of initial marketing authorisation application, Hydrocortisone Aguettant INN hydrocortisone Market authorisation applicant Laboratoire Aguettant Therapeutic indication Prevention of bronchopulmonary…, Public-health recommendation, Oxbryta INN voxelotor Market authorisation applicant Pfizer Europe MA EEIG More information EMA confirms suspension of sickle cell disease medicine Oxbryta, , Other updates Start of Union reviews adopted during the CHMP meeting of 13-16…

Published: Oct 17, 2025 | Category: EMA | Name: EMA News

Minutes of the CVMP meeting 15-17 July 2025

Published: Oct 17, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CVMP meeting 10-12 June 2025

Published: Oct 16, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CVMP meeting 9-10 September 2025

Published: Oct 16, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Guide for rapporteurs and coordinators on the multinational assessment teams

Published: Oct 15, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Agenda - Medicine Shortages (SPOC) Working Party meeting on 14-15 October 2025

Published: Oct 14, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - PDCO agenda of the 14-17 October 2025 meeting

Published: Oct 14, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Annex to agenda of the CHMP meeting 13-16 October 2025

Published: Oct 13, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the CHMP meeting 13-16 October 2025

Published: Oct 13, 2025 | Category: EMA | Name: EMA Agenda and Minutes

PMS Product user interface (PUI) Training: Product data submission & bulk edit made easy, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 October 2025, 10:00 (CEST) to 6 October 2025, 12:00 (CEST)

PMS Product user interface (PUI) Training: Product data submission & bulk edit made easy, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 October 2025, 10:00 (CEST) to 6 October 2025, 12:00 (CEST)

Published: Oct 10, 2025 | Category: EMA | Name: EMA Events

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 7-9 October 2025

CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a positive opinion for a marketing authorisation from Zoetis Belgium for Lenivia…

Published: Oct 10, 2025 | Category: EMA | Name: EMA News

European Medicines Agency (EMA) and European Respiratory Society (ERS) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 October 2025, 13:00 (CET) to 30 October 2025, 15:00 (CET)

European Medicines Agency (EMA) and European Respiratory Society (ERS) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 October 2025, 13:00 (CET) to 30 October 2025, 15:00 (CET)

Published: Oct 10, 2025 | Category: EMA | Name: EMA Events

ICH M14 guideline on general principles on planning, designing, analysing, and reporting of non-interventional studies that utilise real-world data for safety assessment of medicines Step 5

Published: Oct 10, 2025 | Category: EMA | Name: EMA Scientific Guidelines

EMA workshop: Non-clinical data for regulatory decision-making on the efficacy of medical countermeasures, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 November 2025, 09:00 (CET) to 25 November 2025, 16:00 (CET)

EMA workshop: Non-clinical data for regulatory decision-making on the efficacy of medical countermeasures, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 November 2025, 09:00 (CET) to 25 November 2025, 16:00 (CET)

Published: Oct 8, 2025 | Category: EMA | Name: EMA Events

Minutes of the CHMP written procedure 18-21 August 2025

Published: Oct 7, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the CAT meeting 8-9 October 2025

Published: Oct 7, 2025 | Category: EMA | Name: EMA Agenda and Minutes

European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties meeting with all eligible organisations - 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 18 November 2025 to 1

European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties meeting with all eligible organisations - 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 18 November 2025 to 19 November 2025

Published: Oct 7, 2025 | Category: EMA | Name: EMA Events

HMA-EMA joint Network Data Steering Group meeting - 16 September 2025

Published: Oct 7, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Public webinar on shortages: putting patients first, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 4 November 2025, 14:00 (CET) to 4 November 2025, 16:00 (CET)

Published: Oct 7, 2025 | Category: EMA | Name: EMA Events

Medicine shortages: EMA public webinar putting patients first, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 4 November 2025, 14:00 (CET) to 4 November 2025, 16:00 (CET)

Medicine shortages: EMA public webinar putting patients first, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 4 November 2025, 14:00 (CET) to 4 November 2025, 16:00 (CET)

Published: Oct 7, 2025 | Category: EMA | Name: EMA Events

Agenda - Instrument for Pre-accession Assistance (IPA) training on assessing medicinal products in the EU: A practical introduction

Published: Oct 7, 2025 | Category: EMA | Name: EMA Agenda and Minutes

EMA/HMA annual data forum, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 9 December 2025, 09:30 (CET) to 9 December 2025, 17:30 (CET)

Published: Oct 7, 2025 | Category: EMA | Name: EMA Events

Agenda of the CVMP meeting 7-9 October 2025

Published: Oct 7, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the COMP meeting 7-8 October 2025

Published: Oct 6, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Scientific advice on MRL classification of chemical-unlike biological substances considered as not requiring an MRL evaluation according to Regulation (EU) 2018/782

Published: Oct 6, 2025 | Category: EMA | Name: EMA Procedural Guidelines

EMA Management Board: highlights of October 2025 meeting

EMA mid-year report 2025EMA presented results and achievements of its operations for the first half of 2025. Between January and June, applications for new medicines (orphan…

Published: Oct 3, 2025 | Category: EMA | Name: EMA News

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 September - 2 October 2025

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines:…, Agenda Agenda of the PRAC meeting 29 September - 2 October 2025Draft…, PRAC statistics: October 2025 , PRAC statistics: October 2025 English (EN) (100.81 KB - PDF)First…, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association…

Published: Oct 3, 2025 | Category: EMA | Name: EMA News

Agenda - Management Board meeting: 2 October 2025

Published: Oct 2, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes - Enpr-EMA Coordinating Group & networks meeting - June 2025

Published: Oct 2, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Advice on end-of-year submission dates for type I variations in 2025

EMA is advising marketing authorisation holders to submit individual type IA and type IAIN variations and super-groupings for 2025 no later than 21 November 2025. This will…

Published: Oct 2, 2025 | Category: EMA | Name: EMA News

Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1: Registration requirements

Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1: Registration requirements

Published: Oct 2, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Guideline on in-use stability testing of veterinary medicinal products

Published: Oct 1, 2025 | Category: EMA | Name: EMA Scientific Guidelines

Minutes of the CAT meeting 12-14 August 2025 - written procedure

Published: Sep 30, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CAT meeting 16-18 July 2025

Published: Sep 30, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Draft guideline on the clinical evaluation of medicinal products intended for the treatment of chronic hepatitis B (CHB) - Revision 1

Published: Sep 30, 2025 | Category: EMA | Name: EMA Public Consultations

Draft guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis - Revision 1

Published: Sep 30, 2025 | Category: EMA | Name: EMA Public Consultations

Concept paper on new guidance on the clinical investigation of medicinal products for the treatment of idiopathic pulmonary fibrosis (IPF)

Published: Sep 30, 2025 | Category: EMA | Name: EMA Public Consultations

Agenda of the PRAC meeting 29 September - 2 October 2025

Published: Sep 29, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the HMPC meeting 7-9 July 2025

Published: Sep 29, 2025 | Category: EMA | Name: EMA Agenda and Minutes

HMA-EMA joint Network Data Steering Group meeting - 17 July 2025

Published: Sep 29, 2025 | Category: EMA | Name: EMA Agenda and Minutes

ACT EU multi-stakeholder platform annual meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 29 October 2025, 09:30 (CET) to 29 October 2025, 17:00 (CET)

Published: Sep 29, 2025 | Category: EMA | Name: EMA Events

A path to better include patients’ perspectives in the regulation of medicines

EMA has published a draft reflection paper on patient experience data for public consultation. These are data directly reflecting patients’ experience or preferences on treatments…

Published: Sep 29, 2025 | Category: EMA | Name: EMA News

Minutes of the COMP meeting 15-17 July 2025

Published: Sep 26, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Enpr-EMA Coordinating Group and networks meeting June 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, 11 June 2025

Published: Sep 26, 2025 | Category: EMA | Name: EMA Events

Minutes - PDCO minutes of the 22-25 July 2025 meeting

Published: Sep 26, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Industry stakeholder webinar on revised environmental risk assessment guideline for medicinal products for human use - 1 year experience, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 October 2025, 14:30 (CEST) to 6 October 2025, 1

Industry stakeholder webinar on revised environmental risk assessment guideline for medicinal products for human use - 1 year experience, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 October 2025, 14:30 (CEST) to 6 October 2025, 17:00 (CEST)

Published: Sep 26, 2025 | Category: EMA | Name: EMA Events

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2025

Published: Sep 25, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Eltrombopag film-coated tablets 12.5 mg, 25 mg, 50 mg, 75 mg and powder for oral suspension 25 mg product-specific bioequivalence guidance

Published: Sep 25, 2025 | Category: EMA | Name: EMA Public Consultations

Melatonin prolonged release tablets 2 mg product-specific bioequivalence guidance

Published: Sep 25, 2025 | Category: EMA | Name: EMA Public Consultations

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - September 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 September 2025, 1

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - September 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 September 2025, 10:00 (CEST) to 18 September 2025, 11:00 (CEST)

Published: Sep 24, 2025 | Category: EMA | Name: EMA Events

New co-chairs elected for working parties for healthcare professionals and for patients and consumers

EMA’s Patients and Consumer Working Party (PCWP) has elected Marco Greco of the European Patients Forum as its new co-chair. The Healthcare Professionals’ Working Party (HCPWP)…, Marco Greco is a lawyer by training and has extensive advocacy experience. He is a longstanding PCWP member and has served two terms for both the Pharmacovigilance Risk Assessment…, "The PCWP is a model of how patients can meaningfully contribute to the work of EMA, ensuring the patient voice is heard across the breadth of the Agency’s activities. At a…, Dr Piotr Szymanski brings over 30 years of experience as a senior cardiologist, professor, and policy advisor across clinical, academic, regulatory, and digital health domains. He…, "Early and sustained engagement with healthcare professional and patient organisations - across areas such as medicines development, clinical trials, pharmacovigilance,…, The PCWP and HCPWP are formal working parties of EMA, composed of representative organisations of patients, consumers and healthcare professionals as well as representatives from…

Published: Sep 24, 2025 | Category: EMA | Name: EMA News

Minutes of the 128th meeting of the EMA Management Board: 11-12 June 2025

Published: Sep 24, 2025 | Category: EMA | Name: EMA Agenda and Minutes

New targets for clinical trials in Europe

The European Commission (EC), the Heads of Medicines Agencies (HMA) and EMA have jointly developed two new targets for clinical trials, to monitor progress against the ambition to…

Published: Sep 23, 2025 | Category: EMA | Name: EMA News

Use of paracetamol during pregnancy unchanged in the EU

In the EU, paracetamol (also known as acetaminophen) can be used for reducing pain or fever during pregnancy if clinically needed. There is currently no new evidence that would…, “Paracetamol remains an important option to treat pain or fever in pregnant women. Our advice is based on a rigorous assessment of the available scientific data and we have…, As included in the product information for paracetamol in the EU, a large amount of data from pregnant women who used paracetamol during pregnancy indicates no risk of…

Published: Sep 23, 2025 | Category: EMA | Name: EMA News

New variations guidelines to streamline lifecycle management of medicines

EMA welcomes the publication of the European Commission’s (EC) new Variations Guidelines, which streamline the lifecycle management of medicines (see EC news). These guidelines…

Published: Sep 22, 2025 | Category: EMA | Name: EMA News

Agenda of the HMPC meeting 22-24 September 2025

Published: Sep 22, 2025 | Category: EMA | Name: EMA Agenda and Minutes

CHMP PROM minutes for the meeting on 17 March 2025

Published: Sep 22, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 24 September 2025

Published: Sep 22, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - August 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 28 August 2025, 10:00 (

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - August 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 28 August 2025, 10:00 (CEST) to 28 August 2025, 11:00 (CEST)

Published: Sep 19, 2025 | Category: EMA | Name: EMA Events

1st EMA/HMA multi-stakeholder forum on EudraVigilance and signal detection, European Medicines Agency, Amsterdam, the Netherlands, 5 November 2025

Published: Sep 19, 2025 | Category: EMA | Name: EMA Events

First EMA/HMA multi-stakeholder forum on EudraVigilance and signal detection, European Medicines Agency, Amsterdam, the Netherlands, 5 November 2025

Published: Sep 19, 2025 | Category: EMA | Name: EMA Events

First treatment recommended for rare immunoglobulin-related autoimmune disease

EMA’s human medicines committee (CHMP) has recommended extending the therapeutic indication of Uplizna (inebilizumab) to include the treatment of adult patients with active…

Published: Sep 19, 2025 | Category: EMA | Name: EMA News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025

14 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its September 2025 meeting.The committee recommended…, CHMP statistics , CHMP statistics: Text versionSeptember 2025 statistics - monthly and cumulative figures for CHMP opinions and withdrawn applications:14 positive opinions on new medicines: 4…, Positive recommendations on new medicines , Enflonsia International non-proprietary name (INN) clesrovimab Marketing…, Imaavy INN nipocalimab Marketing authorisation applicant…, Kyinsu INN insulin icodec / semaglutide  Marketing authorisation applicant…, Lynkuet INN elinzanetant Marketing authorisation applicant…, Positive recommendations on new biosimilar medicines , Acvybra INN Denosumab Marketing authorisation applicant…, Degevma INN denosumab Marketing authorisation applicant…, Denosumab Intas INN denosumab Marketing authorisation applicant…, Gobivaz INN golimumab  Marketing authorisation applicant…, Kefdensis INN denosumab Marketing authorisation applicant…, Ponlimsi INN denosumab Marketing authorisation applicant…, Usgena INN ustekinumab Marketing authorisation applicant…, Xbonzy INN denosumab Marketing authorisation applicant…, Zvogra INN denosumab Marketing authorisation applicant…, Positive recommendations on new generic medicines , Rivaroxaban Koanaa INN rivaroxaban Marketing authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Bimervax INN COVID-19 vaccine  Marketing authorisation holder…, Dupixent INN dupilumab Marketing authorisation holder…, Keytruda INN pembrolizumab Marketing authorisation holder…, Koselugo INN selumetinib Marketing authorisation holder…, Tezspire INN tezepelumab Market authorisation holder…, Uplizna INN inebilizumab Marketing authorisation holder…, Withdrawal of initial marketing authorisation application , Fanskya INN mozafancogene autotemcel Market authorisation applicant…, Amtagvi INN lifileucel Market authorisation applicant…, Tuzodi INN Midazolam Marketing authorisation applicant…, Omforro INN Midazolam Marketing authorisation applicant…, Re-examinations of initial applications , Atropine sulfate FGK INN atropine Marketing authorisation applicant…, Winlevi INN clascoterone Marketing authorisation applicant…, Other updates , Questions and answer on the outcome of assessment on use of Lutathera in treatment of gastro-entero-pancreatic neuroendocrine tumours in adolescentsReference Number: EMA/299422/…, Lunsumio INN mosunetuzumab Marketing authorisation holder…, Norvir INN ritonavir Market authorisation holder…

Published: Sep 19, 2025 | Category: EMA | Name: EMA News

Procedural advice on appointment and responsibilities of the CVMP rapporteur and co-rapporteur in accordance with Article 140(6) of Regulation (EU) 2019/6, and peer reviewer

Published: Sep 19, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Q&A clinic on Substance, Organisation, Referentials Management Services, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 8 September 2025, 11:00 (CEST) to 8 September 2025, 12:00 (CEST)

Q&A clinic on Substance, Organisation, Referentials Management Services, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 8 September 2025, 11:00 (CEST) to 8 September 2025, 12:00 (CEST)

Published: Sep 18, 2025 | Category: EMA | Name: EMA Events

Cancer Medicines Forum: June 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 17 June 2025, 14:00 (CEST) to 17 June 2025, 17:00 (CEST)

Published: Sep 18, 2025 | Category: EMA | Name: EMA Events

First European Medicines Agency (EMA) and Association of Clinical Research Organizations (ACRO) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 2 September 2025

Published: Sep 17, 2025 | Category: EMA | Name: EMA Events

Orphan designation: idebenone Treatment of Leber's hereditary optic neuropathy, 16/02/2007 Expired

Published: Sep 16, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Panobinostat Treatment of multiple myeloma, 08/11/2012 Expired

Published: Sep 16, 2025 | Category: EMA | Name: EMA Orphan

LinkedIn Live: Smarter trials, stronger Europe. New targets for clinical research., European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 September 2025, 14:00 (CEST) to 24 September 2025, 15:00 (CEST)

LinkedIn Live: Smarter trials, stronger Europe. New targets for clinical research., European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 September 2025, 14:00 (CEST) to 24 September 2025, 15:00 (CEST)

Published: Sep 16, 2025 | Category: EMA | Name: EMA Events

Committee for Medicinal Products for Human Use (CHMP): 15-18 September 2025, European Medicines Agency, Amsterdam, the Netherlands, from 15 September 2025 to 18 September 2025

Published: Sep 15, 2025 | Category: EMA | Name: EMA Events

Annex to agenda of the CHMP meeting 15-18 September 2025

Published: Sep 15, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the CHMP meeting 15-18 September 2025

Published: Sep 15, 2025 | Category: EMA | Name: EMA Agenda and Minutes

European Medicines Agency (EMA) and European Association of Urology (EAU) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, 10 October 2025

Published: Sep 12, 2025 | Category: EMA | Name: EMA Events

First European Medicines Agency (EMA) and European Association for the Study of Diabetes (EASD) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 September 2025, 10:30 (CEST) to 26 September 2025, 12:00 (CEST)

First European Medicines Agency (EMA) and European Association for the Study of Diabetes (EASD) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 September 2025, 10:30 (CEST) to 26 September 2025, 12:00 (CEST)

Published: Sep 12, 2025 | Category: EMA | Name: EMA Events

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 9-10 September 2025

CVMP opinions on veterinary medicinal productsThe Committee adopted, by majority, a positive opinion for a marketing authorisation from Zoetis Belgium for Portela (…

Published: Sep 12, 2025 | Category: EMA | Name: EMA News

PRIME eligibility requests: 2026 deadlines for submission and timetable for assessment

Published: Sep 10, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Management Board formally approves renewal of Executive Director’s mandate

EMA's Management Board has unanimously approved the renewal of the mandate of the Agency’s Executive Director Emer Cooke, extending her tenure until 30 April 2027.The Board's…

Published: Sep 10, 2025 | Category: EMA | Name: EMA News

Minutes of the PRAC meeting 7-10 July 2025

Published: Sep 10, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 10 September 2025, 09:30 (CEST) to 10 September 2025, 13:00 (CEST)

Published: Sep 10, 2025 | Category: EMA | Name: EMA Events

Agenda of the CAT meeting 10-12 September 2025

Published: Sep 9, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - PDCO agenda of the 9-12 September 2025 meeting

Published: Sep 9, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the COMP meeting 9-11 September 2025

Published: Sep 9, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting September 2025, European Medicines Agency, Amsterdam, the Netherlands, from 24 September 2025, 09:00 (CEST) to 24 September 2025, 16:10 (CEST)

Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting September 2025, European Medicines Agency, Amsterdam, the Netherlands, from 24 September 2025, 09:00 (CEST) to 24 September 2025, 16:10 (CEST)

Published: Sep 9, 2025 | Category: EMA | Name: EMA Events

Patients and Consumers Working Party (PCWP) plenary meeting September 2025, European Medicines Agency, Amsterdam, the Netherlands, from 23 September 2025, 08:45 (CEST) to 23 September 2025, 12:00 (CEST)

Patients and Consumers Working Party (PCWP) plenary meeting September 2025, European Medicines Agency, Amsterdam, the Netherlands, from 23 September 2025, 08:45 (CEST) to 23 September 2025, 12:00 (CEST)

Published: Sep 9, 2025 | Category: EMA | Name: EMA Events

Healthcare Professionals' Working Party (HCPWP) plenary meeting September 2025, European Medicines Agency, Amsterdam, the Netherlands, from 23 September 2025, 14:00 (CEST) to 23 September 2025, 17:30 (CEST)

Healthcare Professionals' Working Party (HCPWP) plenary meeting September 2025, European Medicines Agency, Amsterdam, the Netherlands, from 23 September 2025, 14:00 (CEST) to 23 September 2025, 17:30 (CEST)

Published: Sep 9, 2025 | Category: EMA | Name: EMA Events

Agenda of the CVMP meeting 9-11 September 2025

Published: Sep 8, 2025 | Category: EMA | Name: EMA Agenda and Minutes

GIDWG Stakeholder Meeting: 1-3 October 2025, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 3 October 2025, 12:30 (CEST) to 3 October 2025, 14:00 (CEST)

Published: Sep 8, 2025 | Category: EMA | Name: EMA Events

Global IDMP Working Group (GIDWG) Stakeholder Meeting: 1-3 October 2025, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 3 October 2025, 12:30 (CEST) to 3 October 2025, 14:00 (CEST)

Global IDMP Working Group (GIDWG) Stakeholder Meeting: 1-3 October 2025, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 3 October 2025, 12:30 (CEST) to 3 October 2025, 14:00 (CEST)

Published: Sep 8, 2025 | Category: EMA | Name: EMA Events

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1 – 4 September 2025

Review will assess risk of leukoencephalopathy, a condition affecting the brainEMA’s safety committee (PRAC) has started a review of medicines containing levamisole, authorised in…, Agenda Agenda of the PRAC meeting 1-4 September 2025DraftReference Number: EMA/PRAC/234907/2025 English (EN…, PRAC statistics: September 2025 , PRAC statistics: September 2025 English (EN) (33.17 MB - PDF)First published: 05/09/2025View, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association…

Published: Sep 5, 2025 | Category: EMA | Name: EMA News

Orphan designation: relacorilant Treatment of ovarian cancer, 25/07/2023 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: botaretigene sparoparvovec Treatment of inherited retinal dystrophies due to defects in the RPGR gene, 23/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: human IgG1 (296-cysteine,301-glycine,306-cysteine) monoclonal antibody against TREM2 Treatment of CSF1R-related leukoencephalopathy, 13/10/2023 Withdrawn

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: adeno-associated viral vector containing a modified U7 snRNA gene Treatment of Duchenne muscular dystrophy, 27/07/2005 Withdrawn

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: adeno-associated virus vector serotype 9 encoding human gigaxonin gene Treatment of giant axonal neuropathy, 13/04/2022 Withdrawn

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: hydrocortisone Treatment of adrenal insufficiency, 20/03/2007 Withdrawn

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: nanatinostat,valganciclovir Treatment of peripheral T-cell lymphoma, 10/08/2022 Withdrawn

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: valganciclovir,nanatinostat Treatment of diffuse large B-cell lymphoma, 13/01/2023 Withdrawn

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: 2-[6-(6,7-Dimethoxyquinolin-3-yl)pyridin-3-yl]-N-[3-(1,1,1-trifluoro-2-methylpropan-2-yl)-1,2-oxazol-5-yl]acetamide (zeteletinib) Treatment of medullary thyroid carcinoma, 19/02/2021 Withdrawn

Orphan designation: 2-[6-(6,7-Dimethoxyquinolin-3-yl)pyridin-3-yl]-N-[3-(1,1,1-trifluoro-2-methylpropan-2-yl)-1,2-oxazol-5-yl]acetamide (zeteletinib) Treatment of medullary thyroid carcinoma, 19/02/2021 Withdrawn

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Interferon gamma Treatment of Friedreich's ataxia, 09/12/2011 Withdrawn

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: humanised IgG1 kappa monoclonal antibody against tyrosine-protein phosphatase non-receptor type substrate 1, signal-regulatory protein beta-1 and signal-regulatory protein gamma Treatment of haemophagocytic lymphohistiocytosis, 18/07/2

Orphan designation: humanised IgG1 kappa monoclonal antibody against tyrosine-protein phosphatase non-receptor type substrate 1, signal-regulatory protein beta-1 and signal-regulatory protein gamma Treatment of haemophagocytic lymphohistiocytosis, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: allogeneic peripheral blood-derived T-cells, fratricide-resistant, transduced with a lentivirus vector expressing a chimeric antigen receptor against CD7 Treatment of acute lymphoblastic leukaemia, 18/07/2025 Positive

Orphan designation: allogeneic peripheral blood-derived T-cells, fratricide-resistant, transduced with a lentivirus vector expressing a chimeric antigen receptor against CD7 Treatment of acute lymphoblastic leukaemia, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: aglatimagene besadenovec Treatment of pancreatic cancer, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: methotrexate Treatment of non-syndromic inherited retinal dystrophies of the rod-dominant phenotype, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: sonlicromanol hydrochloride Treatment of inherited mitochondrial oxidative phosphorylation defects, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Ivosidenib Treatment of myelodysplastic syndromes, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: telitacicept Treatment of myasthenia gravis, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: curcumin Treatment of Charcot-Marie-Tooth disease, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: ribavirin Treatment of hepatitis E, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: avutometinib,defactinib Treatment of ovarian cancer, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: palmitoyl-conjugated tricyclo-DNA antisense oligonucleotide 5'-Palm-C6-*GGA GAT GgC AGT TTC-3 Treatment of Duchenne muscular dystrophy, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: luminol monosodium Treatment of Duchenne muscular dystrophy, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: human bispecific monoclonal antibody targeting ALK1 and BMPRII Treatment of hereditary haemorrhagic telangiectasia, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: adeno-associated viral vector serotype 9 containing the human CTNNB1 gene Treatment of autosomal dominant polycystic kidney disease, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: octreotide hydrochloride Treatment of autosomal dominant polycystic kidney disease, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: phosphorodiamidate morpholino oligonucleotide against the CUG repeat expansion of the DMPK gene mRNA transcript, conjugated to a cell penetrating peptide Treatment of dystrophic myotonia, 18/07/2025 Positive

Orphan designation: phosphorodiamidate morpholino oligonucleotide against the CUG repeat expansion of the DMPK gene mRNA transcript, conjugated to a cell penetrating peptide Treatment of dystrophic myotonia, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: resecabtagene autoleucel Treatment of idiopathic inflammatory myopathy, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Elafibranor Treatment of primary sclerosing cholangitis, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: nuvisertib Treatment of myelofibrosis, 18/07/2025 Positive

Published: Sep 4, 2025 | Category: EMA | Name: EMA Orphan

Warning about sharp rise in illegal medicines sold in the EU

EMA and the Heads of Medicines Agencies (HMA) are warning the public about the growing threat of illegal medicines being advertised and sold online across the European Union…

Published: Sep 3, 2025 | Category: EMA | Name: EMA News

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 6: Examples for submission of legacy data (obsolete)

Published: Sep 2, 2025 | Category: EMA | Name: EMA Procedural Guidelines

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 4: Process and format for the submission of legacy data on veterinary medicinal products (obsolete)

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 4: Process and format for the submission of legacy data on veterinary medicinal products (obsolete)

Published: Sep 2, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Agenda of the PRAC meeting 1-4 September 2025

Published: Sep 1, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Clinical Trials Information System (CTIS): Walk-in clinic September 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 September 2025, 16:00 (CEST) to 24 September 2025, 17:00 (CEST)

Clinical Trials Information System (CTIS): Walk-in clinic September 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 September 2025, 16:00 (CEST) to 24 September 2025, 17:00 (CEST)

Published: Sep 1, 2025 | Category: EMA | Name: EMA Events

EMA and WHO mark ten years of collaboration to advance global access to medicines

EMA and the World Health Organization (WHO) are celebrating a decade of formal collaboration and shared commitment to address global health challenges. Since the signing of a…, "Global health relies on trusted partnerships. In a very unpredictable world where public health issues go beyond national borders, these partnerships are more necessary…, A key initiative for collaboration is EMA’s EU Medicines for all (EU-M4all) programme that enables EMA, in cooperation with the WHO, to support global regulatory capacity building…

Published: Sep 1, 2025 | Category: EMA | Name: EMA News

Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated terms

Published: Sep 1, 2025 | Category: EMA | Name: EMA Procedural Guidelines

14th Industry Standing Group (ISG) meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 September 2025, 09:00 (CEST) to 30 September 2025, 13:15 (CEST)

Published: Sep 1, 2025 | Category: EMA | Name: EMA Events

European Platform for Regulatory Science Research meeting September 2025 , Online, European Medicines Agency, Amsterdam, the Netherlands, from 29 September 2025, 14:00 (CEST) to 29 September 2025, 17:30 (CEST)

European Platform for Regulatory Science Research meeting September 2025 , Online, European Medicines Agency, Amsterdam, the Netherlands, from 29 September 2025, 14:00 (CEST) to 29 September 2025, 17:30 (CEST)

Published: Sep 1, 2025 | Category: EMA | Name: EMA Events

Minutes of the CAT meeting 11-13 June 2025

Published: Aug 29, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Guideline on good pharmacovigilance practices (GVP) - Module XVI Addendum I – Risk minimisation measures for medicinal products with embryo-fetal risks

Published: Aug 28, 2025 | Category: EMA | Name: EMA Scientific Guidelines

Minutes - PDCO minutes of the 17-20 June 2025 meeting

Published: Aug 27, 2025 | Category: EMA | Name: EMA Agenda and Minutes

First webinar on new approach methodologies (NAMs) in ecotoxicology: State of the science for bioaccumulation, Online, from 10 September 2025, 14:00 (CEST) to 10 September 2025, 15:00 (CEST)

Published: Aug 21, 2025 | Category: EMA | Name: EMA Events

CHMP PROM minutes for the meeting on 14 April 2025

Published: Aug 19, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the PRAC meeting 2-5 June 2025

Published: Aug 19, 2025 | Category: EMA | Name: EMA Agenda and Minutes

HCPWP plenary meeting September 2025, European Medicines Agency, Amsterdam, the Netherlands, from 23 September 2025, 14:00 (CEST) to 23 September 2025, 17:30 (CEST)

Published: Aug 18, 2025 | Category: EMA | Name: EMA Events

PCWP/HCPWP joint meeting September 2025, European Medicines Agency, Amsterdam, the Netherlands, from 24 September 2025, 09:00 (CEST) to 24 September 2025, 16:10 (CEST)

Published: Aug 18, 2025 | Category: EMA | Name: EMA Events

PCWP plenary meeting September 2025, European Medicines Agency, Amsterdam, the Netherlands, from 23 September 2025, 08:45 (CEST) to 23 September 2025, 12:00 (CEST)

Published: Aug 18, 2025 | Category: EMA | Name: EMA Events

Annual open meeting of the European Network of Paediatric Research at EMA (Enpr-EMA) November 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 November 2025, 09:00 (CET) to 20 November 2025, 16:45 (CET)

Annual open meeting of the European Network of Paediatric Research at EMA (Enpr-EMA) November 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 November 2025, 09:00 (CET) to 20 November 2025, 16:45 (CET)

Published: Aug 18, 2025 | Category: EMA | Name: EMA Events

Annex to 22-25 April 2025 CHMP Minutes

Published: Aug 14, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CHMP meeting 22-25 April 2025

Published: Aug 14, 2025 | Category: EMA | Name: EMA Agenda and Minutes

CHMP PROM minutes for the meeting on 17 February 2025

Published: Aug 14, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Quarterly System Demo – Q3 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 17 September 2025, 09:00 (CEST) to 17 September 2025, 12:45 (CEST)

Published: Aug 14, 2025 | Category: EMA | Name: EMA Events

Eighth EMA-Medicines for Europe bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 9 September 2025, 15:00 (CEST) to 9 September 2025, 17:00 (CEST)

Published: Aug 14, 2025 | Category: EMA | Name: EMA Events

EMA closed on 15 August for Assumption Day

The European Medicines Agency's (EMA) office is closed from 18:00 on Thursday 14 August 2025 to 08:30 on Monday 18 August 2025.Outside of working hours and on public holidays…

Published: Aug 13, 2025 | Category: EMA | Name: EMA News

Agenda - Multi-stakeholder workshop on tailored clinical approach for biosimilars

Published: Aug 7, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Concept paper on the need for revision of the guideline on the clinical investigation of medicines for the treatment of Alzheimer's disease

Published: Aug 6, 2025 | Category: EMA | Name: EMA Public Consultations

Training session on human variations web-based electronic application form (eAF) for CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 15 September 2025, 10:00 (CEST) to 15 September 2025, 11:30 (CEST)

Training session on human variations web-based electronic application form (eAF) for CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 15 September 2025, 10:00 (CEST) to 15 September 2025, 11:30 (CEST)

Published: Aug 1, 2025 | Category: EMA | Name: EMA Events

Q&A clinic on web-based application form functionalities for CAPs and non-CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, from 9 October 2025, 11:00 (CEST) to 9 October 2025, 12:00 (CEST)

Q&A clinic on web-based application form functionalities for CAPs and non-CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, from 9 October 2025, 11:00 (CEST) to 9 October 2025, 12:00 (CEST)

Published: Aug 1, 2025 | Category: EMA | Name: EMA Events

Q&A clinic on web-based electronic application form (eAF) functionalities for CAPs and non-CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 September 2025, 10:00 (CEST) to 30 September 2025, 11:00 (CEST)

Q&A clinic on web-based electronic application form (eAF) functionalities for CAPs and non-CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 September 2025, 10:00 (CEST) to 30 September 2025, 11:00 (CEST)

Published: Aug 1, 2025 | Category: EMA | Name: EMA Events

Training session on human variations web-based electronic Application Form (eAF) for non-CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 10 September 2025, 10:00 (CEST) to 10 September 2025, 11:30 (CEST)

Training session on human variations web-based electronic Application Form (eAF) for non-CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 10 September 2025, 10:00 (CEST) to 10 September 2025, 11:30 (CEST)

Published: Aug 1, 2025 | Category: EMA | Name: EMA Events

List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products for 2025

List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products for 2025

Published: Jul 31, 2025 | Category: EMA | Name: EMA Procedural Guidelines

EMA Cancer Medicines Forum (CMF) meeting with industry stakeholders on cancer treatment optimisation, Online, European Medicines Agency, Amsterdam, the Netherlands, from 14 November 2025, 13:30 (CET) to 14 November 2025, 17:30 (CET)

EMA Cancer Medicines Forum (CMF) meeting with industry stakeholders on cancer treatment optimisation, Online, European Medicines Agency, Amsterdam, the Netherlands, from 14 November 2025, 13:30 (CET) to 14 November 2025, 17:30 (CET)

Published: Jul 30, 2025 | Category: EMA | Name: EMA Events

Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance

Published: Jul 29, 2025 | Category: EMA | Name: EMA Scientific Guidelines

Workshop on a tailored clinical approach in biosimilar development, Online, European Medicines Agency, Amsterdam, the Netherlands, from 22 September 2025, 10:00 (CEST) to 22 September 2025, 16:00 (CEST)

Workshop on a tailored clinical approach in biosimilar development, Online, European Medicines Agency, Amsterdam, the Netherlands, from 22 September 2025, 10:00 (CEST) to 22 September 2025, 16:00 (CEST)

Published: Jul 29, 2025 | Category: EMA | Name: EMA Events

Committee for Advanced Therapies (CAT) workshop on gene editing, Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 September 2025, 10:00 (CEST) to 16 September 2025, 17:00 (CEST)

Published: Jul 25, 2025 | Category: EMA | Name: EMA Events

EU Medicines Assessment - Opportunities for expert involvement, Online, European Medicines Agency, Amsterdam, the Netherlands, from 9 July 2025, 15:00 (CEST) to 9 July 2025, 16:15 (CEST)

Published: Jul 25, 2025 | Category: EMA | Name: EMA Events

Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group

Published: Jul 25, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Orphan designation: Humanised IgG1 monoclonal antibody against adrenocorticotropic hormone Treatment of congenital adrenal hyperplasia, 20/06/2025 Positive

Published: Jul 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: 4-Amino-1-[(2R,4S,5S)-5-(1,2-dihydroxyethyl)-4-hydroxyoxolan-2-yl]pyrimidin-2-one Treatment of glioma, 20/06/2025 Positive

Published: Jul 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: empasiprubart Treatment of multifocal motor neuropathy, 20/06/2025 Positive

Published: Jul 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Exidavnemab Treatment of multiple system atrophy, 20/06/2025 Positive

Published: Jul 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Alpha-N-acetyl glucosaminidase fused to a humanised monoclonal antibody against transferrin receptor Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome), 20/06/2025 Positive

Orphan designation: Alpha-N-acetyl glucosaminidase fused to a humanised monoclonal antibody against transferrin receptor Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome), 20/06/2025 Positive

Published: Jul 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: 2-[[Hydroxy[(R)-2-[((5Z,8Z,11Z,14Z)-eicosa-5,8,11,14-tetraenoyl)oxy]-3-(octadecyloxy)propoxy]phosphoryl]oxy]ethan-1-amine Treatment of Rett syndrome, 20/06/2025 Positive

Published: Jul 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Dipalmitoyl hydroxyproline Treatment of Netherton syndrome, 20/06/2025 Positive

Published: Jul 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Humanised IgG4 bispecific monoclonal antibody against sclerostin and dickkopf-related protein 1 Treatment of osteogenesis imperfecta, 20/06/2025 Positive

Published: Jul 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: bezuclastinib Treatment of mastocytosis, 20/06/2025 Positive

Published: Jul 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Beta-lapachone Treatment of primary sclerosing cholangitis, 20/06/2025 Positive

Published: Jul 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: 1-(3-Bromobenzyl)-N3-(3,4-dichlorophenyl)-1H-1,2,4-triazole-3,5-diamine Treatment of radiation induced maculopathy, 20/06/2025 Positive

Published: Jul 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: 3-(Carbamoylamino)-5-[2-(3-fluorophenyl)ethynyl]-N-[(3S)-piperidin-3-yl]thiophene-2-carboxamide hydrochloric acid Treatment of acute myeloid leukaemia, 20/06/2025 Positive

Published: Jul 25, 2025 | Category: EMA | Name: EMA Orphan

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2025

13 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 13 medicines for approval at its July 2025 meeting.The committee recommended granting a…, CHMP statistics Key figures from the July 2025 CHMP meeting are represented in the graphic below., CHMP statistics: Text versionJuly 2025 statistics - monthly and cumulative figures for CHMP opinions and withdrawn applications:13 positive opinions on new medicines: 2 new non…, Positive recommendations on new medicines , Aqneursa International non-proprietary name (INN) L-Acetylleucine Marketing…, Ekterly INN sebetralstat Marketing authorisation applicant…, Romvimza INN vimseltinib Marketing authorisation applicant…, Tryngolza INN olezarsen Marketing authorisation applicant…, Voranigo INN vorasidenib Marketing authorisation applicant…, Yeytuo INN lenacapavir Marketing authorisation applicant…, Zurzuvae INN zuranolone Marketing authorisation applicant…, Positive recommendations on new biosimilar medicines , Bildyos INN denosumab  Marketing authorisation applicant…, Bilprevda INN denosumab Marketing authorisation applicant…, Eyluxvi INN aflibercept  Marketing authorisation applicant…, Usrenty INN ustekinumab Marketing authorisation applicant…, Positive recommendations on new generic medicines , Macitentan Accord INN macitentan Marketing authorisation applicant…, Macitentan AccordPharma INN macitentan Marketing authorisation applicant…, Positive recommendation on medicine for use outside the European Union , Lenacapavir Gilead INN lenacapavir Marketing authorisation applicant…, Withdrawal of initial marketing authorisation application , Aplidin INN plitidepsin Therapeutic indication…, Ifinwil INN eflornithine Marketing authorisation applicant…, Nidlegy INN bifikafusp alfa / onfekafusp alfa  Marketing authorisation…, Negative opinions of initial marketing authorisation applications , Elevidys INN delandistrogene moxeparvovec  Marketing authorisation applicant…, Jelrix INN autologous cartilage-derived articular chondrocytes, in-vitro expanded…, Nurzigma INN pridopidine  Marketing authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Alhemo INN concizumab Marketing authorisation holder…, Baqsimi INN glucagon Marketing authorisation holder…, Clopidogrel Zentiva INN clopidogrel Marketing authorisation holder…, Invokana INN canagliflozin Marketing authorisation holder…, mResvia INN single-stranded 5' capped mRNA encoding the respiratory syncytial virus glycoprotein F stabilized in…, Sirturo INN bedaquiline Marketing authorisation holder…, Taltz INN ixekizumab Marketing authorisation holder…, Tevimbra INN tislelizumab Marketing authorisation holder…, Re-examinations of initial applications , Kisunla INN donanemab Marketing authorisation applicant…, Start of referral procedure , Tecovirimat SIGA INN tecovirimat More information…, Other updates Questions and answers on the outcome of assessment on use of Neuraceq to monitor treatment responseReference Number: EMA/310493/2020…

Published: Jul 25, 2025 | Category: EMA | Name: EMA News

First reformulation of an inhaled medicine with environmentally friendly gas propellant

EMA has recommended a change in the composition of Trixeo Aerosphere and its duplicate product Riltrava Aerosphere to replace the existing gas propellant with a low global…

Published: Jul 25, 2025 | Category: EMA | Name: EMA News

New injection for easier prevention of HIV infection in the EU and worldwide

EMA has recommended granting a marketing authorisation in the European Union (EU) for Yeytuo (lenacapavir) for pre-exposure prophylaxis (PrEP) in combination with safer…, Related contentMeeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2025

Published: Jul 25, 2025 | Category: EMA | Name: EMA News

Orphan designation: 3-((4-(1-((1-(6-(((S)-2,6-Dioxopiperidin-3-yl)carbamoyl)pyridin-3-yl)piperidin-4-yl)methyl)piperidin-4-yl)phenyl)amino)-5-((R)-3-(3-methyl-2-oxoimidazolidin-1-yl)piperidin-1-yl)pyrazine-2-carboxamide Treatment of lymphoplasmacytic lymp

Orphan designation: 3-((4-(1-((1-(6-(((S)-2,6-Dioxopiperidin-3-yl)carbamoyl)pyridin-3-yl)piperidin-4-yl)methyl)piperidin-4-yl)phenyl)amino)-5-((R)-3-(3-methyl-2-oxoimidazolidin-1-yl)piperidin-1-yl)pyrazine-2-carboxamide Treatment of lymphoplasmacytic lymphoma, 20/06/2025 Positive

Published: Jul 25, 2025 | Category: EMA | Name: EMA Orphan

New treatment for Niemann-Pick type C disease

EMA has recommended granting a marketing authorisation in the European Union (EU) for Aqneursa (levacetylleucine) for the treatment of neurological manifestations of Niemann-Pick…

Published: Jul 25, 2025 | Category: EMA | Name: EMA News

Orphan designation: Elesclomol-copper Treatment of Menkes disease, 22/06/2025 Positive

Published: Jul 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: zanidatamab Treatment of biliary tract cancer, 27/06/2025 Positive

Published: Jul 25, 2025 | Category: EMA | Name: EMA Orphan

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with new Addendum II to Module VI on masking of personal data in individual case safety reports submitted to EudraVigilance

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with new Addendum II to Module VI on masking of personal data in individual case safety reports submitted to EudraVigilance

Published: Jul 24, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Guideline on good pharmacovigilance practices (GVP) - Module VI Addendum II – Masking of personal data in individual case safety reports submitted to EudraVigilance

Published: Jul 24, 2025 | Category: EMA | Name: EMA Procedural Guidelines

EMA Paediatric Committee elects Sabine Scherer as its new chair

At its July 2025 meeting, EMA’s Paediatric Committee (PDCO), elected Sabine Scherer from Germany as its new chair for a three-year mandate, beginning in September 2025.Dr Scherer…, She is currently involved in several PDCO initiatives and working groups, dealing with topics such as extrapolation, mechanism of action PDCO representatives in the European…, "It is a great honour to be appointed to chair EMA’s paediatric committee. My ambition is to work together with the European Medicines Regulatory Network to further advance…, The main role of the PDCO is to prospectively guide sponsors or companies on how to consider a medicine’s use in children during its development. In this context, the…

Published: Jul 24, 2025 | Category: EMA | Name: EMA News

HMA/EMA multi-stakeholder workshop on artificial intelligence, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 20 November 2025, 13:00 (CET) to 21 November 2025, 13:00 (CET)

HMA/EMA multi-stakeholder workshop on artificial intelligence, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 20 November 2025, 13:00 (CET) to 21 November 2025, 13:00 (CET)

Published: Jul 24, 2025 | Category: EMA | Name: EMA Events

Guideline on the pharmaceutical quality of inhalation and nasal medicinal products - Revision 1

Published: Jul 24, 2025 | Category: EMA | Name: EMA Scientific Guidelines

HMA-EMA joint Network Data Steering Group meeting 27 June 2025

Published: Jul 24, 2025 | Category: EMA | Name: EMA Agenda and Minutes

HMA-EMA joint Network Data Steering Group meeting - 28 May 2025

Published: Jul 24, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Workshop on the use of external controls for evidence generation in regulatory decision-making, Online, European Medicines Agency, Amsterdam, the Netherlands, 3 November 2025

Published: Jul 23, 2025 | Category: EMA | Name: EMA Events

Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP)

Published: Jul 23, 2025 | Category: EMA | Name: EMA Procedural Guidelines

5th Veterinary Big Data Stakeholder Forum, Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 November 2025, 10:00 (CET) to 10 November 2025, 15:00 (CET)

Published: Jul 23, 2025 | Category: EMA | Name: EMA Events

Agenda - PDCO agenda of the 22-25 July 2025 meeting

Published: Jul 22, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 23 July 2025

Published: Jul 22, 2025 | Category: EMA | Name: EMA Agenda and Minutes

EMA multi-stakeholder workshop on the clinical evaluation of therapeutic radiopharmaceuticals in oncology, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 17 November 2025, 09:00 (CET) to 17 November 2025, 15:00 (CET)

EMA multi-stakeholder workshop on the clinical evaluation of therapeutic radiopharmaceuticals in oncology, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 17 November 2025, 09:00 (CET) to 17 November 2025, 15:00 (CET)

Published: Jul 22, 2025 | Category: EMA | Name: EMA Events

Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 July 2025, 10:00 (CEST) to 8 July 2025, 11:00 (CEST)

Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 July 2025, 10:00 (CEST) to 8 July 2025, 11:00 (CEST)

Published: Jul 22, 2025 | Category: EMA | Name: EMA Events

Refresher training webinar on post-authorisation procedure management in IRIS for marketing authorisation holders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 September 2025, 10:00 (CEST) to 30 September 2025, 12:00 (CEST)

Refresher training webinar on post-authorisation procedure management in IRIS for marketing authorisation holders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 September 2025, 10:00 (CEST) to 30 September 2025, 12:00 (CEST)

Published: Jul 22, 2025 | Category: EMA | Name: EMA Events

Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD) - Revision 2

Published: Jul 21, 2025 | Category: EMA | Name: EMA Scientific Guidelines

Annex to 21-24 July 2025 CHMP Agenda

Published: Jul 21, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the CHMP meeting 21-24 July 2025

Published: Jul 21, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Thirteenth Nitrosamine Implementation Oversight Group (NIOG) meeting, European Medicines Agency, Amsterdam, the Netherlands, 7 May 2025

Published: Jul 21, 2025 | Category: EMA | Name: EMA Events

European Medicines Agency Write PMS API implementation Guide

Published: Jul 18, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-17 July 2025

CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a positive opinion for a marketing authorisation from Axience for Hemosyvet(etamsylate) for…

Published: Jul 18, 2025 | Category: EMA | Name: EMA News

Orphan designation: Humanised IgG1 monoclonal antibody against human eotaxin-2,nebokitug Treatment of primary sclerosing cholangitis, 21/08/2020 Positive

Published: Jul 17, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Felzartamab Treatment of primary IgA nephropathy, 11/11/2024 Positive

Published: Jul 17, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: 68Ga-2,2'-(7-(4-((S)-1-((4S,7S,10S,13R,16S,19R)-4-((R)-1-amino-3-(4-hydroxyphenyl)-1-oxopropan-2-ylcarbamoyl)-10-(4-aminobutyl)-16-(4-((S)-2,6-dioxohexahydropyrimidine-4-carboxamido)benzyl)-7-((R)-1-hydroxyethyl)-6,9,12,15,18-pentaoxo-

Orphan designation: 68Ga-2,2'-(7-(4-((S)-1-((4S,7S,10S,13R,16S,19R)-4-((R)-1-amino-3-(4-hydroxyphenyl)-1-oxopropan-2-ylcarbamoyl)-10-(4-aminobutyl)-16-(4-((S)-2,6-dioxohexahydropyrimidine-4-carboxamido)benzyl)-7-((R)-1-hydroxyethyl)-6,9,12,15,18-pentaoxo-13-(4-ureidobenzyl)-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-19-ylamino)-3-(4-chlorophenyl)-1-oxopropan-2-ylamino)-1-carboxy-4-oxobutyl)-1,4,7-triazonane-1,4-diyl)diacetic acid (satoreotide trixozetan) ,satoreotide trizoxetan gallium (Ga68) Diagnosis of gastro-entero-pancreatic neuroendocrine tumours, 19/02/2014 Positive

Published: Jul 17, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is coval

Orphan designation: synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues (Vutrisiran) Treatment of transthyretin-mediated amyloidosis (ATTR amyloidosis), 25/05/2018 Positive

Published: Jul 17, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: lepunafusp alfa Treatment of mucopolysaccharidosis type I, 26/03/2021 Positive

Published: Jul 17, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: (2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidine-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridine-2-yl)-4-fluoropyrrolidine-2-carboxamide Treatment of C3 glomerulopathy, 21/03/2018 Withdrawn

Orphan designation: (2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidine-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridine-2-yl)-4-fluoropyrrolidine-2-carboxamide Treatment of C3 glomerulopathy, 21/03/2018 Withdrawn

Published: Jul 17, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: utreloxastat Treatment of amyotrophic lateral sclerosis, 09/12/2022 Withdrawn

Published: Jul 17, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Obecabtagene autoleucel Treatment of acute lymphoblastic leukaemia, 13/04/2022 Withdrawn

Published: Jul 17, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: iloprost Treatment of systemic sclerosis, 20/06/2025 Positive

Published: Jul 17, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: (R)-3-(5-dimethylcarbamoyl-pent-1-enyl)-N-(2-hydroxy-1methylethyl)benzamide Treatment of fragile X syndrome Positive

Published: Jul 17, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: 2-(2-(2-[2-(4-Benzothiazol-2-yl-phenoxy)-ethoxy]-ethoxy)-ethoxy)-ethanol Treatment of amyotrophic lateral sclerosis, 20/06/2025 Positive

Published: Jul 17, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: sodium 2-(3'(-3-(1-(4-(tert-butyl)benzyl)-4-ethyl-5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)propyl)-4-ethoxy-[1,1'-biphenyl]-3-yl)acetate Treatment of hepatocellular carcinoma, 20/06/2025 Positive

Orphan designation: sodium 2-(3'(-3-(1-(4-(tert-butyl)benzyl)-4-ethyl-5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)propyl)-4-ethoxy-[1,1'-biphenyl]-3-yl)acetate Treatment of hepatocellular carcinoma, 20/06/2025 Positive

Published: Jul 17, 2025 | Category: EMA | Name: EMA Orphan

13th Industry Standing Group (ISG) meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 June 2025, 09:00 (CEST) to 30 June 2025, 13:15 (CEST)

Published: Jul 17, 2025 | Category: EMA | Name: EMA Events

Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse events in animals and humans - Rev.17

Published: Jul 16, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Clinical Trials Information System (CTIS) Bitesize talk: Redesign of the CTIS training material for sponsor users, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 9 July 2025, 15:30 (CEST) to 9 July 2025, 17:00 (CEST)

Clinical Trials Information System (CTIS) Bitesize talk: Redesign of the CTIS training material for sponsor users, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 9 July 2025, 15:30 (CEST) to 9 July 2025, 17:00 (CEST)

Published: Jul 16, 2025 | Category: EMA | Name: EMA Events

Agenda of the CAT meeting 16-18 July 2025

Published: Jul 15, 2025 | Category: EMA | Name: EMA Agenda and Minutes

European Platform for Regulatory Science Research meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 May 2025, 14:00 (CEST) to 20 May 2025, 16:30 (CEST)

Published: Jul 15, 2025 | Category: EMA | Name: EMA Events

Agenda of the COMP meeting 15-17 July 2025

Published: Jul 15, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the CVMP meeting 15-17 July 2025

Published: Jul 15, 2025 | Category: EMA | Name: EMA Agenda and Minutes

EMA Information Day on submission predictability of initial marketing authorisation December 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 December 2025, 13:30 (CET) to 3 December 2025, 17:30 (CET)

EMA Information Day on submission predictability of initial marketing authorisation December 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 December 2025, 13:30 (CET) to 3 December 2025, 17:30 (CET)

Published: Jul 14, 2025 | Category: EMA | Name: EMA Events

Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) multistakeholder workshop on Patient Registries for Alzheimer's disease, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 15 December 2025, 09:00 (CET) t

Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) multistakeholder workshop on Patient Registries for Alzheimer's disease, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 15 December 2025, 09:00 (CET) to 15 December 2025, 17:30 (CET)

Published: Jul 14, 2025 | Category: EMA | Name: EMA Events

Unlocking PMS API potential: Edit functionality training for MAHs, Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 October 2025, 10:00 (CEST) to 16 October 2025, 11:30 (CEST)

Published: Jul 11, 2025 | Category: EMA | Name: EMA Events

PMS PUI Training: Product data submission & bulk edit made easy, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 October 2025, 10:00 (CEST) to 6 October 2025, 12:00 (CEST)

Published: Jul 11, 2025 | Category: EMA | Name: EMA Events

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 – 10 July 2025

Vaccine to be used only when there is a significant chikungunya risk and after careful consideration of the benefits and risks EMA’s safety committee (PRAC) has completed its…, Agenda Agenda of the PRAC meeting 7-10 July 2025DraftReference Number: EMA/PRAC/202278/2025 English (EN…, PRAC statistics: July 2025 , , Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association…

Published: Jul 11, 2025 | Category: EMA | Name: EMA News

Ixchiq: temporary restriction on vaccinating people 65 years and older to be lifted

EMA’s safety committee (PRAC) has completed its review of Ixchiq (a live attenuated chikungunya vaccine), following reports of serious side effects.The previous temporary…

Published: Jul 11, 2025 | Category: EMA | Name: EMA News

Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - Revision 1

Published: Jul 10, 2025 | Category: EMA | Name: EMA Public Consultations

Ledipasvir/sofosbuvir film-coated tablet 45 mg/200 mg and 90 mg/400 mg, coated granules 33.75mg/150mg and 45mg/200mg product-specific bioequivalence guidance - Revision 1

Published: Jul 10, 2025 | Category: EMA | Name: EMA Scientific Guidelines

Orphan designation: tasimelteon Treatment of non-24-hour sleep-wake disorders in blind people with no light perception, 23/02/2011 Expired

Published: Jul 9, 2025 | Category: EMA | Name: EMA Orphan

Minutes of the HMPC meeting 5-7 May 2025

Published: Jul 9, 2025 | Category: EMA | Name: EMA Agenda and Minutes

14th industry stakeholder platform on research and development support, European Medicines Agency, Amsterdam, the Netherlands, from 3 July 2025, 12:30 (CEST) to 3 July 2025, 17:30 (CEST)

Published: Jul 9, 2025 | Category: EMA | Name: EMA Events

Training session on Human variations web-based electronic Application Form (eAF) for non-CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, from 1 July 2025, 10:00 (CEST) to 1 July 2025, 11:30 (CEST)

Training session on Human variations web-based electronic Application Form (eAF) for non-CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, from 1 July 2025, 10:00 (CEST) to 1 July 2025, 11:30 (CEST)

Published: Jul 9, 2025 | Category: EMA | Name: EMA Events

Minutes - PDCO minutes of the 20-23 May 2025 meeting

Published: Jul 8, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CHMP meeting 24-27 February 2025

Published: Jul 8, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Annex to 24-27 February 2025 CHMP Minutes

Published: Jul 8, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CAT meeting 14-16 May 2025

Published: Jul 8, 2025 | Category: EMA | Name: EMA Agenda and Minutes

CHMP PROM minutes for the meeting on 20 January 2025

Published: Jul 8, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Pharmacovigilance Risk Assessment Committee (PRAC): 7 - 10 July 2025, European Medicines Agency, Amsterdam, the Netherlands, from 7 July 2025 to 10 July 2025

Published: Jul 7, 2025 | Category: EMA | Name: EMA Events

Agenda of the PRAC meeting 7-10 July 2025

Published: Jul 7, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 13 May 2025, 09:30 (CEST) to 13 May 2025, 13:00 (CEST)

Published: Jul 7, 2025 | Category: EMA | Name: EMA Events

Minutes of the PRAC meeting 5-8 May 2025

Published: Jul 4, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Strengthening supply chain of anti-D immunoglobulins

EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued…

Published: Jul 4, 2025 | Category: EMA | Name: EMA News

Agenda of the HMPC meeting 7-9 July 2025

Published: Jul 4, 2025 | Category: EMA | Name: EMA Agenda and Minutes

First EMA-ACRO bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 2 September 2025

Published: Jul 3, 2025 | Category: EMA | Name: EMA Events

Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products - Rev.16

Published: Jul 3, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Minutes of the COMP meeting 13-15 May 2025

Published: Jul 1, 2025 | Category: EMA | Name: EMA Agenda and Minutes

QRD guidance on the use of adopted abbreviations and pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised (DCP), subsequent recognition (SRP) and national procedures

QRD guidance on the use of adopted abbreviations and pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised (DCP), subsequent recognition (SRP) and national procedures

Published: Jul 1, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Orphan designation: Humanised IgG1 monoclonal antibody against human epidermal growth factor receptor 2 Treatment of gastric cancer, 22/05/2025 Positive

Published: Jun 30, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: taladegib Treatment of idiopathic pulmonary fibrosis, 22/05/2025 Positive

Published: Jun 30, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: 1-{4-[2-(5-ethoxymethyl-2-methyl-phenylamino)-oxazol-5-yl]-phenyl}-imidazolidin-2-one Treatment of acute myeloid leukaemia, 22/05/2025 Positive

Published: Jun 30, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Induced pluripotent stem cells-derived myogenic progenitor cells Treatment of Becker muscular dystrophy, 22/05/2025 Positive

Published: Jun 30, 2025 | Category: EMA | Name: EMA Orphan

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course for sponsors - September 2025, Online, from 29 September 2025, 09:00 (CEST) to 30 September 2025, 13:30 (CEST)

Published: Jun 30, 2025 | Category: EMA | Name: EMA Events

ICH E20 guideline on adaptive designs for clinical trials - Step 2b

Published: Jun 30, 2025 | Category: EMA | Name: EMA Public Consultations

Orphan designation: ramiprilat Treatment of Stargardt's disease, 12/03/2013 Withdrawn

Published: Jun 30, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: (S)-2-isobutyrylamino-pentanedioic acid 5-amide 1-{[(2S,5S,8S,11R,12S,15S,18S,21R)-2,8-bis-((S)-sec-butyl)-21-hydroxy-5-(4-hydroxy-benzyl)-15-isobutyl-4,11-dimethyl-3,6,9,13,16,22-hexaoxo-10-oxa-1,4,7,14,17-pentaaza-bicyclo[16.3.1]doco

Orphan designation: (S)-2-isobutyrylamino-pentanedioic acid 5-amide 1-{[(2S,5S,8S,11R,12S,15S,18S,21R)-2,8-bis-((S)-sec-butyl)-21-hydroxy-5-(4-hydroxy-benzyl)-15-isobutyl-4,11-dimethyl-3,6,9,13,16,22-hexaoxo-10-oxa-1,4,7,14,17-pentaaza-bicyclo[16.3.1]docos-12-yl]-amide} Treatment of Netherton syndrome, 17/10/2019 Withdrawn

Published: Jun 30, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: adeno-associated virus serotype C102 containing the human GLA gene Treatment of Fabry disease, 13/04/2022 Withdrawn

Published: Jun 30, 2025 | Category: EMA | Name: EMA Orphan

Quarterly System Demo - Q2 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 26 June 2025, 09:00 (CEST) to 26 June 2025, 10:45 (CEST)

Published: Jun 30, 2025 | Category: EMA | Name: EMA Events

EudraVigilance registration manual

Published: May 23, 2025 | Category: EMA | Name: EMA Procedural Guidelines

EudraVigilance - EVWEB user manual

Published: May 23, 2025 | Category: EMA | Name: EMA Procedural Guidelines

HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 October 2025, 10:00 (CEST) to 9 October 2025, 16:10 (CEST)

HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 October 2025, 10:00 (CEST) to 9 October 2025, 16:10 (CEST)

Published: May 23, 2025 | Category: EMA | Name: EMA Events

Minutes of the Cancer Medicines Forum - March 2025

Published: May 23, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Concept paper on the development of a guideline on consumer safety of active substances of immunological veterinary medicinal products acting against endogenous targets

Published: May 23, 2025 | Category: EMA | Name: EMA Public Consultations

Training session for patients, consumers and healthcare professionals involved in medicine regulatory activities July 2025, European Medicines Agency, Amsterdam, the Netherlands, from 2 July 2025, 09:30 (CEST) to 2 July 2025, 16:15 (CEST)

Training session for patients, consumers and healthcare professionals involved in medicine regulatory activities July 2025, European Medicines Agency, Amsterdam, the Netherlands, from 2 July 2025, 09:30 (CEST) to 2 July 2025, 16:15 (CEST)

Published: May 22, 2025 | Category: EMA | Name: EMA Events

European Society of Cardiology (ESC) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 22 May 2025, 15:00 (CEST) to 22 May 2025, 17:00 (CEST)

Published: May 21, 2025 | Category: EMA | Name: EMA Events

Agenda - PDCO agenda of the 20-23 May 2025 meeting

Published: May 20, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Committee for Medicinal Products for Human Use (CHMP): 19-22 May 2025, European Medicines Agency, Amsterdam, the Netherlands, from 19 May 2025 to 22 May 2025

Published: May 19, 2025 | Category: EMA | Name: EMA Events

Summary of changes to the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’ - Version 1.5

Published: May 15, 2025 | Category: EMA | Name: EMA Procedural Guidelines

External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use - Version 1.5

Published: May 15, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - July 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 22 July 2025, 11:00 (CEST

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - July 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 22 July 2025, 11:00 (CEST) to 22 July 2025, 12:00 (CEST)

Published: May 15, 2025 | Category: EMA | Name: EMA Events

Fourteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 June 2025, 13:00 (CEST) to 23 June 2025, 18:00 (CEST)

Fourteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 June 2025, 13:00 (CEST) to 23 June 2025, 18:00 (CEST)

Published: May 15, 2025 | Category: EMA | Name: EMA Events

PMF dossier requirements - Questions and answers for PMF holders

Published: May 14, 2025 | Category: EMA | Name: EMA Procedural Guidelines

European shortages monitoring platform (ESMP): updates and question and answer (Q&A) clinic for marketing authorisation holders (MAHs), Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 June 2025, 10:30 (CEST) to 24 June 2025, 12:00 (

European shortages monitoring platform (ESMP): updates and question and answer (Q&A) clinic for marketing authorisation holders (MAHs), Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 June 2025, 10:30 (CEST) to 24 June 2025, 12:00 (CEST)

Published: May 14, 2025 | Category: EMA | Name: EMA Events

Agenda of the CAT meeting 14-16 May 2025

Published: May 14, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the COMP meeting 13-15 May 2025

Published: May 14, 2025 | Category: EMA | Name: EMA Agenda and Minutes

EMA workshop on primary efficacy endpoints for antivirals and mAbs intended for the treatment of COVID-19 and Influenza, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 5 June 2025, 13:00 (CEST) to 6 June 2025, 17:00 (CEST)

EMA workshop on primary efficacy endpoints for antivirals and mAbs intended for the treatment of COVID-19 and Influenza, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 5 June 2025, 13:00 (CEST) to 6 June 2025, 17:00 (CEST)

Published: May 12, 2025 | Category: EMA | Name: EMA Events

EMA workshop on primary efficacy endpoints for antivirals and monoclonal antibodies intended for the treatment of COVID-19 and influenza, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 5 June 2025, 13:00 (CEST) to 6 June 20

EMA workshop on primary efficacy endpoints for antivirals and monoclonal antibodies intended for the treatment of COVID-19 and influenza, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 5 June 2025, 13:00 (CEST) to 6 June 2025, 17:00 (CEST)

Published: May 12, 2025 | Category: EMA | Name: EMA Events

Minutes of the HMPC meeting 17-19 March 2025

Published: May 12, 2025 | Category: EMA | Name: EMA Agenda and Minutes

EMA/FVE info session for veterinary practitioners : Understanding the first report of sales and use of antimicrobials in animals, Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 June 2024, 15:30 (CEST) to 3 June 2024, 16:30 (CEST)

EMA/FVE info session for veterinary practitioners : Understanding the first report of sales and use of antimicrobials in animals, Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 June 2024, 15:30 (CEST) to 3 June 2024, 16:30 (CEST)

Published: May 12, 2025 | Category: EMA | Name: EMA Events

Draft qualification opinion for Simcyp Simulator

Published: May 8, 2025 | Category: EMA | Name: EMA Public Consultations

European Medicines Agency Write PMS API implementation Guide (zip)

Published: May 8, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Concept paper on the revision of Part IV guidelines on good manufacturing practice specific to advanced therapy medicinal products

Published: May 8, 2025 | Category: EMA | Name: EMA Public Consultations

Agenda - EMA’s 30th anniversary scientific conference

Published: May 7, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Workshop on the use of Bayesian statistics in clinical development, Online, European Medicines Agency, Amsterdam, the Netherlands, 17 June 2025

Published: May 7, 2025 | Category: EMA | Name: EMA Events

Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (April 2025)

Published: May 6, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the PRAC meeting 5-8 May 2025

Published: May 6, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2 - track changes

Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2 - track changes

Published: May 6, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2

Published: May 6, 2025 | Category: EMA | Name: EMA Procedural Guidelines

CVMP Interested Parties’ meeting May 2025, European Medicines Agency, Amsterdam, the Netherlands, from 14 May 2024, 17:00 (CEST) to 14 May 2024, 19:00 (CEST)

Published: May 5, 2025 | Category: EMA | Name: EMA Events

Agenda of the HMPC meeting 5-7 May 2025

Published: May 2, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Draft ICH Q1 guideline on stability testing of drug substances and drug products - Step 2b

Published: Apr 30, 2025 | Category: EMA | Name: EMA Public Consultations

Minutes of the CAT meeting 19-21 March 2025

Published: Apr 28, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda - Extraordinary Management Board meeting: 28 April 2025

Published: Apr 28, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Orphan designation: octreotide hydrochloride Treatment of acromegaly, 12/06/2009 Positive

Published: Apr 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Zanidatamab Treatment of biliary tract cancer, 19/07/2021 Positive

Published: Apr 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: (S)-2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one Treatment of hyperphenylalaninemia, 20/05/2021 Positive

Published: Apr 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: (14S)-8-[3-(2-{dispiro[2.0.24.13]heptan-7-yl}ethoxy)-1H-pyrazol-1-yl]-12,12-dimethyl-2lamba6-thia-3,9,11,18,23-penta-azatetracyclo[17.3.1.111,14.05,10]tetracosa-1(22),5,7,9,19(23),20-hexaene-2,2,4-trione calcium salt hydrate, deutivaca

Orphan designation: (14S)-8-[3-(2-{dispiro[2.0.24.13]heptan-7-yl}ethoxy)-1H-pyrazol-1-yl]-12,12-dimethyl-2lamba6-thia-3,9,11,18,23-penta-azatetracyclo[17.3.1.111,14.05,10]tetracosa-1(22),5,7,9,19(23),20-hexaene-2,2,4-trione calcium salt hydrate, deutivacaftor, tezacaftor Treatment of cystic fibrosis, 12/11/2021 Positive

Published: Apr 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: diflunisal Treatment of ATTR amyloidosis, 21/06/2022 Positive

Published: Apr 25, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (darvadstrocel) Treatment of anal fistula, 08/10/2009 Withdrawn

Published: Apr 24, 2025 | Category: EMA | Name: EMA Orphan

Minutes of the CVMP meeting 11-13 March 2025

Published: Apr 16, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Call for scientific data for the use in HMPC assessment work on Valerianae radix and Passiflorae herba

Published: Apr 15, 2025 | Category: EMA | Name: EMA Public Consultations

Procedural advice on paediatric applications

Published: Apr 15, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Agenda of the CAT meeting 14-16 April 2025

Published: Apr 14, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Quality Review of Documents (QRD) annotated template v11: Draft for public consultation

Published: Apr 14, 2025 | Category: EMA | Name: EMA Public Consultations

Key information section in package leaflet of centrally authorised medicinal products: Public consultation

Published: Apr 14, 2025 | Category: EMA | Name: EMA Public Consultations

Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)

Published: Apr 11, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Minutes - PDCO minutes of the 25-28 February 2025 meeting

Published: Apr 10, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the PRAC meeting 10-13 February 2025

Published: Apr 9, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Amended Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU recommendations for the seasonal influenza vaccine composition for the season 2025/2026

Published: Apr 9, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Minutes of the PRAC meeting 28-31 October 2024

Published: Apr 9, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the PRAC meeting 2-5 September 2024

Published: Apr 9, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the PRAC meeting 13-16 May 2024

Published: Apr 9, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Orphan designation: imetelstat sodium Treatment of myelodysplastic syndromes, 27/07/2020 Positive

Published: Apr 9, 2025 | Category: EMA | Name: EMA Orphan

ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b

Published: Apr 9, 2025 | Category: EMA | Name: EMA Public Consultations

Orphan designation: Unesbulin Treatment of soft tissue sarcoma, 10/12/2021 Withdrawn

Published: Apr 9, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Lactobacillus plantarum Treatment of amyotrophic lateral sclerosis, 16/12/2019 Withdrawn

Published: Apr 9, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Alrefimotide acetate,riletamotide acetate,tapderimotide acetate Treatment of mesothelioma, 21/03/2024 Withdrawn

Published: Apr 9, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Glofitamab Treatment of diffuse large B-cell lymphoma, 15/10/2021 Withdrawn

Published: Apr 9, 2025 | Category: EMA | Name: EMA Orphan

EMA roundtable with stakeholders on the 20th anniversary of the SME Regulation, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 17 October 2025, 09:30 (CEST) to 17 October 2025, 13:30 (CEST)

EMA roundtable with stakeholders on the 20th anniversary of the SME Regulation, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 17 October 2025, 09:30 (CEST) to 17 October 2025, 13:30 (CEST)

Published: Apr 8, 2025 | Category: EMA | Name: EMA Events

Agenda of the CVMP meeting 8-10 April 2025

Published: Apr 8, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 April 2025, European Medicines Agency, Amsterdam, the Netherlands, from 7 April 2025 to 10 April 2025

Published: Apr 7, 2025 | Category: EMA | Name: EMA Events

Orphan designation: single guide RNA containing a sequence complementary to human ALB locus gene, intron 1, target region, Ziclumeran Treatment of haemophilia B, 25/03/2025 Positive

Published: Apr 7, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: povetacicept Treatment of primary IgA nephropathy, 25/03/2025 Positive

Published: Apr 7, 2025 | Category: EMA | Name: EMA Orphan

Quality Innovation Group (QIG) Listen and Learn Focus Group (LLFG) meeting on personalised medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 April 2025, 10:00 (CEST) to 9 April 2025, 15:30 (CEST)

Quality Innovation Group (QIG) Listen and Learn Focus Group (LLFG) meeting on personalised medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 April 2025, 10:00 (CEST) to 9 April 2025, 15:30 (CEST)

Published: Apr 7, 2025 | Category: EMA | Name: EMA Events

Orphan designation: extract from Cannabis flower, containing high levels of cannabidiolic acid and <0.3% of tetrahydrocannabinol, Extraction solvent: olive oil, virgin Treatment of Rett syndrome, 25/03/2025 Positive

Orphan designation: extract from Cannabis flower, containing high levels of cannabidiolic acid and <0.3% of tetrahydrocannabinol, Extraction solvent: olive oil, virgin Treatment of Rett syndrome, 25/03/2025 Positive

Published: Apr 7, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: allopurinol Treatment of Marfan syndrome, 25/03/2025 Positive

Published: Apr 7, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: adeno-associated virus vector serotype 8 containing the human F9 gene Treatment of haemophilia B, 25/03/2025 Positive

Published: Apr 7, 2025 | Category: EMA | Name: EMA Orphan

Thirteenth meeting of the industry stakeholder platform on research and development support, European Medicines Agency, Amsterdam, the Netherlands, 2 December 2024

Published: Apr 4, 2025 | Category: EMA | Name: EMA Events

Orphan designation: bexmarilimab Treatment of myelodysplastic syndromes, 25/03/2025 Positive

Published: Apr 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: ixodes ricinus contact phase inhibitor Treatment of non-traumatic spontaneous intracerebral haemorrhage, 25/03/2025 Positive

Published: Apr 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains Treatment

Orphan designation: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains Treatment of multiple myeloma, 04/06/2020 Withdrawn

Published: Apr 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Felzartamab Treatment of in solid organ transplantation, 13/12/2024 Positive

Published: Apr 4, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: deucrictibant monohydrate Treatment of bradykinin-mediated angioedema, 25/03/2025 Positive

Published: Apr 4, 2025 | Category: EMA | Name: EMA Orphan

European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes

Published: Apr 4, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 18 March 2025, 09:30 (CET) to 18 March 2025, 13:00 (CET)

Published: Apr 2, 2025 | Category: EMA | Name: EMA Events

Rules of procedure for the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP)

Published: Apr 2, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Fourth listen-and-learn focus group meeting of the Quality Innovation Group, Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 November 2024 to 20 November 2024

Published: Apr 2, 2025 | Category: EMA | Name: EMA Events

Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU recommendations for the seasonal influenza vaccine composition for the season 2025/2026

Published: Apr 1, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Reflection paper on a tailored clinical approach in biosimilar development

Published: Apr 1, 2025 | Category: EMA | Name: EMA Public Consultations

IRIS guide to registration and RPIs

Published: Apr 1, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Minutes of the CAT meeting 19-21 February 2025

Published: Apr 1, 2025 | Category: EMA | Name: EMA Agenda and Minutes

SPOR and xEVMPD Stakeholder Engagement Webinars : Substance, product, organisation and referential (SPOR) application programming interface (API) - SPOR API, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 14 October 2024, 1

SPOR and xEVMPD Stakeholder Engagement Webinars : Substance, product, organisation and referential (SPOR) application programming interface (API) - SPOR API, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 14 October 2024, 10:00 (CEST) to 14 October 2024, 12:00 (CEST)

Published: Apr 1, 2025 | Category: EMA | Name: EMA Events

SPOR and xEVMPD Stakeholder Engagement Webinars : Referentials Management Service (RMS), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 7 October 2024, 10:00 (CEST) to 7 October 2024, 12:00 (CEST)

SPOR and xEVMPD Stakeholder Engagement Webinars : Referentials Management Service (RMS), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 7 October 2024, 10:00 (CEST) to 7 October 2024, 12:00 (CEST)

Published: Apr 1, 2025 | Category: EMA | Name: EMA Events

SPOR and xEVMPD Stakeholder Engagement Webinars : Product Management Service (XEVMPD) for MAH, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 10 October 2024, 10:00 (CEST) to 10 October 2024, 12:00 (CEST)

SPOR and xEVMPD Stakeholder Engagement Webinars : Product Management Service (XEVMPD) for MAH, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 10 October 2024, 10:00 (CEST) to 10 October 2024, 12:00 (CEST)

Published: Apr 1, 2025 | Category: EMA | Name: EMA Events

SPOR and xEVMPD Stakeholder Engagement Webinars : Product Management Service (XEVMPD) for Sponsors, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 11 October 2024, 10:00 (CEST) to 11 October 2024, 12:00 (CEST)

SPOR and xEVMPD Stakeholder Engagement Webinars : Product Management Service (XEVMPD) for Sponsors, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 11 October 2024, 10:00 (CEST) to 11 October 2024, 12:00 (CEST)

Published: Apr 1, 2025 | Category: EMA | Name: EMA Events

SPOR and xEVMPD Stakeholder Engagement Webinars : Substance Management Service (SMS), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 8 October 2024, 10:00 (CEST) to 8 October 2024, 12:00 (CEST)

SPOR and xEVMPD Stakeholder Engagement Webinars : Substance Management Service (SMS), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 8 October 2024, 10:00 (CEST) to 8 October 2024, 12:00 (CEST)

Published: Apr 1, 2025 | Category: EMA | Name: EMA Events

SPOR and xEVMPD Stakeholder Engagement Webinars : SPOR Data Governance, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 4 October 2024, 10:00 (CEST) to 4 October 2024, 12:00 (CEST)

SPOR and xEVMPD Stakeholder Engagement Webinars : SPOR Data Governance, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 4 October 2024, 10:00 (CEST) to 4 October 2024, 12:00 (CEST)

Published: Apr 1, 2025 | Category: EMA | Name: EMA Events

SPOR and xEVMPD Stakeholder Engagement Webinars : Organisation Management Service (OMS), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 9 October 2024, 10:00 (CEST) to 9 October 2024, 12:00 (CEST)

SPOR and xEVMPD Stakeholder Engagement Webinars : Organisation Management Service (OMS), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 9 October 2024, 10:00 (CEST) to 9 October 2024, 12:00 (CEST)

Published: Apr 1, 2025 | Category: EMA | Name: EMA Events

Procedural guidance to scientific committeesꞌ members and experts on completing the European Medicines Agencyꞌs declaration of interests in the Experts Management Tool

Published: Apr 1, 2025 | Category: EMA | Name: EMA Procedural Guidelines

ICMRA Summit 2025, European Medicines Agency, Amsterdam, the Netherlands, from 21 October 2025 to 24 October 2025

Published: Apr 1, 2025 | Category: EMA | Name: EMA Events

Call for scientific data for the periodic review of the monograph on Valerianae radix and Lupuli flos

Published: Apr 1, 2025 | Category: EMA | Name: EMA Public Consultations

Call for scientific data for the periodic review of the monograph on Salicis cortex

Published: Apr 1, 2025 | Category: EMA | Name: EMA Public Consultations

Call for scientific data for the periodic review of the monograph on Psyllii semen

Published: Apr 1, 2025 | Category: EMA | Name: EMA Public Consultations

Call for scientific data for the periodic review of the monograph on Harpagophyti radix

Published: Apr 1, 2025 | Category: EMA | Name: EMA Public Consultations

Call for scientific data for the periodic review of the monograph on Hamamelidis folium et cortex aut ramunculus destillatum

Published: Apr 1, 2025 | Category: EMA | Name: EMA Public Consultations

Call for scientific data for the periodic review of the monograph on Hamamelidis folium

Published: Apr 1, 2025 | Category: EMA | Name: EMA Public Consultations

Call for scientific data for the periodic review of the monograph on Hamamelidis cortex

Published: Apr 1, 2025 | Category: EMA | Name: EMA Public Consultations

Call for scientific data for the periodic review of the monograph on Equiseti herba

Published: Apr 1, 2025 | Category: EMA | Name: EMA Public Consultations

Call for scientific data for the periodic review of the monograph on Carvi fructus

Published: Apr 1, 2025 | Category: EMA | Name: EMA Public Consultations

Call for scientific data for the periodic review of the monograph on Carvi aetheroleum

Published: Apr 1, 2025 | Category: EMA | Name: EMA Public Consultations

Call for scientific data for the periodic review of the monograph on Althaeae radix

Published: Apr 1, 2025 | Category: EMA | Name: EMA Public Consultations

Concept paper on the revision of the guideline on the Scientific Data Requirements for a Plasma Master File (PMF) Revision 1 and Annexes

Published: Mar 31, 2025 | Category: EMA | Name: EMA Public Consultations

Draft guideline on the quality aspects of mRNA vaccines

Published: Mar 31, 2025 | Category: EMA | Name: EMA Public Consultations

Draft Reflection paper on linking to electronic product information (ePI) from EU medicine packages

Published: Mar 31, 2025 | Category: EMA | Name: EMA Public Consultations

EMA’s 30th anniversary scientific conference - Medicines, regulation and the future, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 June 2025, 10:00 (CEST) to 25 June 2025, 16:00 (CEST)

EMA’s 30th anniversary scientific conference - Medicines, regulation and the future, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 June 2025, 10:00 (CEST) to 25 June 2025, 16:00 (CEST)

Published: Mar 28, 2025 | Category: EMA | Name: EMA Events

Orphan designation: Givinostat Treatment of Duchenne muscular dystrophy, 04/07/2012 Positive

Published: Mar 28, 2025 | Category: EMA | Name: EMA Orphan

Agenda – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) 1 April 2025

Published: Mar 28, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Clinical Trials Information System (CTIS): Information day, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 22 May 2025, 12:30 (CEST) to 22 May 2025, 17:30 (CEST)

Published: Mar 28, 2025 | Category: EMA | Name: EMA Events

Minutes of the COMP meeting 18-19 February 2025

Published: Mar 27, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Clinical Trials Information System (CTIS): Walk-in clinic - May 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 14 May 2025, 16:00 (CEST) to 14 May 2025, 17:00 (CEST)

Clinical Trials Information System (CTIS): Walk-in clinic - May 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 14 May 2025, 16:00 (CEST) to 14 May 2025, 17:00 (CEST)

Published: Mar 26, 2025 | Category: EMA | Name: EMA Events

Second EMA / Alliance for Regenerative Medicine bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 May 2025, 14:00 (CEST) to 8 May 2025, 16:00 (CEST)

Published: Mar 25, 2025 | Category: EMA | Name: EMA Events

European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008

Published: Mar 25, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Agenda - PDCO agenda of the 25-28 March 2025 meeting

Published: Mar 25, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CVMP meeting 11-12 February 2025

Published: Mar 25, 2025 | Category: EMA | Name: EMA Agenda and Minutes

EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 October 2025, 10:00 (CEST) to 9 October 2025, 16:10 (CEST)

EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 October 2025, 10:00 (CEST) to 9 October 2025, 16:10 (CEST)

Published: Mar 25, 2025 | Category: EMA | Name: EMA Events

Annex to 24-27 March 2025 CHMP Agenda

Published: Mar 24, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the CHMP meeting 24-27 March 2025

Published: Mar 24, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Orphan designation: Octreotide acetate Treatment of acromegaly, 05/08/2013 Withdrawn

Published: Mar 21, 2025 | Category: EMA | Name: EMA Orphan

Minutes of the HMPC meeting 20-22 January 2025

Published: Mar 20, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the CAT meeting 19-21 March 2025

Published: Mar 18, 2025 | Category: EMA | Name: EMA Agenda and Minutes

ICH M11 Technical Specification - Updated step 2b

Published: Mar 18, 2025 | Category: EMA | Name: EMA Public Consultations

EMA traineeship programme informative session, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 14 April 2025, 10:00 (CEST) to 14 April 2025, 11:00 (CEST)

Published: Mar 18, 2025 | Category: EMA | Name: EMA Events

European Organisation for Research and Treatment of Cancer (EORTC) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 9 April 2025

Published: Mar 17, 2025 | Category: EMA | Name: EMA Events

Scientific advice under Article 115(5) of Regulation (EU) 2019/6 on veterinary medicinal products, regarding the list of substances essential for the treatment of equine species and for which the withdrawal period for equine species shall be six months

Scientific advice under Article 115(5) of Regulation (EU) 2019/6 on veterinary medicinal products, regarding the list of substances essential for the treatment of equine species and for which the withdrawal period for equine species shall be six months

Published: Mar 14, 2025 | Category: EMA | Name: EMA Procedural Guidelines

User guide for micro, small and medium-sized enterprises

Published: Mar 14, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Agenda of the HMPC meeting 17-19 March 2025

Published: Mar 13, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Orphan designation: Trehalose Treatment of neuronal ceroid lipofuscinosis, 19/10/2020 Withdrawn

Published: Mar 12, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Humanised IgG4 monoclonal antibody against C1q Treatment of Guillain-Barré syndrome, 10/02/2025 Positive

Published: Mar 12, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: sutimlimab Treatment of autoimmune haemolytic anaemia, 11/02/2025 Positive

Published: Mar 12, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Upifitamab rilsodotin Treatment of ovarian cancer, 09/12/2022 Withdrawn

Published: Mar 12, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: pelabresib monohydrate Treatment of myelofibrosis, 17/02/2025 Positive

Published: Mar 12, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Adeno-associated viral vector serotype rh10 containing the human cholesterol 24-hydroxylase gene Treatment of Huntington’s disease, 01/04/2019 Withdrawn

Published: Mar 12, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Ornithine phenylacetate Treatment of acute liver failure, 20/02/2025 Positive

Published: Mar 12, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Serplulimab Treatment of small cell lung cancer, 20/02/2025 Positive

Published: Mar 12, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 Treatment of myasthenia gravis, 20/02/2025 Positive

Published: Mar 12, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Seladelpar Treatment of primary biliary cholangitis, 20/02/2025 Positive

Published: Mar 12, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Magrolimab Treatment of myelodysplastic syndromes, 26/06/2020 Withdrawn

Published: Mar 12, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Magrolimab Treatment of acute myeloid leukaemia, 11/11/2015 Withdrawn

Published: Mar 12, 2025 | Category: EMA | Name: EMA Orphan

IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants

Published: Mar 12, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 21 January 2025, 09:30 (CET) to 21 January 2025, 13:00 (CET)

Published: Mar 12, 2025 | Category: EMA | Name: EMA Events

Summary of the Medicine Shortages SPOC Working Party meeting on 21 January 2025

Published: Mar 12, 2025 | Category: EMA | Name: EMA Agenda and Minutes

SPOR and XEVMPD status update webinar, Broadcast, from 9 July 2025, 10:00 (CEST) to 9 July 2025, 12:30 (CEST)

Published: Mar 12, 2025 | Category: EMA | Name: EMA Events

Minutes - PDCO minutes of the 28-31 January 2025 meeting

Published: Mar 12, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Management Board meeting: 13 March 2025, European Medicines Agency, Amsterdam, the Netherlands, 13 March 2025

Published: Mar 12, 2025 | Category: EMA | Name: EMA Events

Agenda - Management Board meeting: 13 March 2025

Published: Mar 12, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the PRAC meeting 13-16 January 2025

Published: Mar 12, 2025 | Category: EMA | Name: EMA Agenda and Minutes

SPOR and XEVMPD status update webinar, Broadcast, from 8 October 2025, 10:00 (CEST) to 8 October 2025, 12:30 (CEST)

Published: Mar 11, 2025 | Category: EMA | Name: EMA Events

Orphan designation: Tafasitamab Treatment of follicular lymphoma, 26/02/2025 Positive

Published: Mar 11, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Rimeporide Treatment of Duchenne muscular dystrophy, 26/02/2025 Positive

Published: Mar 11, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: hydroxocobalamin acetate Treatment of homocystinuria and/or methylmalonic acidaemia due to genetic defects of intracellular cobalamin processing, 26/02/2025 Positive

Published: Mar 11, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Venetoclax Treatment of mantle cell lymphoma, 12/12/2017 Withdrawn

Published: Mar 11, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: adeno-associated virus serotype rh.10 containing the human PKP2 gene Treatment of arrhythmogenic cardiomyopathy caused by pathogenic mutations in the PKP2 gene, 26/02/2025 Positive

Orphan designation: adeno-associated virus serotype rh.10 containing the human PKP2 gene Treatment of arrhythmogenic cardiomyopathy caused by pathogenic mutations in the PKP2 gene, 26/02/2025 Positive

Published: Mar 11, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: (R)-(3-(2'-cyclopropyl-3-(hydroxymethyl)-[1,1'-biphenyl]-4-yl)pyrrolidin-1-yl)(5-hydroxy-6-methylpyridin-2-yl)methanone Treatment of Olmsted syndrome, 26/02/2025 Positive

Published: Mar 11, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Venetoclax Treatment of diffuse large B-cell lymphoma, 14/10/2016 Withdrawn

Published: Mar 11, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Treatment of X-linked hypohidrotic ectodermal dysplasia (Christ-Siemens-Touraine Syndrome), 26/02/2025 Positive

Published: Mar 11, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: paltusotine Treatment of acromegaly, 26/02/2025 Positive

Published: Mar 11, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: adeno-associated virus vector serotype SNY001 containing the human PAH gene Treatment of hyperphenylalaninaemia, 26/02/2025 Positive

Published: Mar 11, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: volixibat potassium Treatment of primary sclerosing cholangitis, 26/02/2025 Positive

Published: Mar 11, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: epertinib Treatment of amyotrophic lateral sclerosis, 26/02/2025 Positive

Published: Mar 11, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Autologous CD34+ cell enriched population containing haematopoietic stem and progenitor cells transduced ex vivo with a lentiviral vector encoding the human ADA2 gene Treatment of adenosine deaminase 2 deficiency (DADA2), 27/02/2025 Po

Orphan designation: Autologous CD34+ cell enriched population containing haematopoietic stem and progenitor cells transduced ex vivo with a lentiviral vector encoding the human ADA2 gene Treatment of adenosine deaminase 2 deficiency (DADA2), 27/02/2025 Positive

Published: Mar 11, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: adeno-associated virus sector serotype rh74 containing the human SGCG gene Treatment of limb-girdle muscular dystrophy, 27/02/2025 Positive

Published: Mar 11, 2025 | Category: EMA | Name: EMA Orphan

Cancer Medicines Forum: December 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 December 2024, 13:00 (CET) to 16 December 2024, 15:00 (CET)

Published: Mar 11, 2025 | Category: EMA | Name: EMA Events

Minutes of the Cancer Medicines Forum - December 2024

Published: Mar 11, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 March 2025, 11:30 (CET) to 13 March 2025, 12:00 (CET)

Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 March 2025, 11:30 (CET) to 13 March 2025, 12:00 (CET)

Published: Mar 10, 2025 | Category: EMA | Name: EMA Events

Pharmacovigilance Risk Assessment Committee (PRAC): 10 - 13 March 2025, European Medicines Agency, Amsterdam, the Netherlands, from 10 March 2025 to 13 March 2025

Published: Mar 10, 2025 | Category: EMA | Name: EMA Events

Agenda of the PRAC meeting 10-13 March 2025

Published: Mar 10, 2025 | Category: EMA | Name: EMA Agenda and Minutes

SPOR and XEVMPD status update webinar, Broadcast, from 9 April 2025, 10:00 (CEST) to 9 April 2025, 12:30 (CEST)

Published: Mar 10, 2025 | Category: EMA | Name: EMA Events

ADRA project - information session for veterinary pharmaceutical industry, Online, European Medicines Agency, Amsterdam, the Netherlands, from 22 May 2025, 14:30 (CEST) to 22 May 2025, 16:00 (CEST)

Published: Mar 10, 2025 | Category: EMA | Name: EMA Events

Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 March 2025, European Medicines Agency, Amsterdam, the Netherlands, from 11 March 2025 to 13 March 2025

Published: Mar 10, 2025 | Category: EMA | Name: EMA Events

Agenda of the CVMP meeting 11-13 March 2025

Published: Mar 10, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CHMP meeting on 14-17 October 2024

Published: Mar 7, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Orphan designation: Ex-vivo-expanded autologous human corneal epithelium-containing stem cells Corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns, 07/11/2008 Expired

Orphan designation: Ex-vivo-expanded autologous human corneal epithelium-containing stem cells Corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns, 07/11/2008 Expired

Published: Mar 7, 2025 | Category: EMA | Name: EMA Orphan

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - March 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 March 2025, 11:00 (CE

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - March 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 March 2025, 11:00 (CET) to 25 March 2025, 12:00 (CET)

Published: Mar 7, 2025 | Category: EMA | Name: EMA Events

Q&A clinic Human variations web-based electronic Application Form (eAF) for non-CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, from 25 October 2024, 10:00 (CEST) to 25 October 2024, 10:30 (CEST)

Q&A clinic Human variations web-based electronic Application Form (eAF) for non-CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, from 25 October 2024, 10:00 (CEST) to 25 October 2024, 10:30 (CEST)

Published: Mar 7, 2025 | Category: EMA | Name: EMA Events

Q&A clinic on human variations web-based electronic application form (eAF), European Medicines Agency, Amsterdam, the Netherlands, from 14 November 2024, 10:00 (CET) to 14 November 2024, 10:30 (CET)

Published: Mar 7, 2025 | Category: EMA | Name: EMA Events

Information and Q&A session on updated CAPs in web-based eAF, Online, European Medicines Agency, Amsterdam, the Netherlands, from 7 May 2024, 10:00 (CEST) to 7 May 2024, 11:00 (CEST)

Published: Mar 7, 2025 | Category: EMA | Name: EMA Events

Human variation electronic application form (eAF) training session and Q&A clinic, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 November 2024, 10:00 (CET) to 8 November 2024, 11:00 (CET)

Human variation electronic application form (eAF) training session and Q&A clinic, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 November 2024, 10:00 (CET) to 8 November 2024, 11:00 (CET)

Published: Mar 7, 2025 | Category: EMA | Name: EMA Events

Training session on Human variations web-based electronic Application Form (eAF) for non-CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 17 October 2024, 10:00 (CEST) to 17 October 2024, 11:30 (CEST)

Training session on Human variations web-based electronic Application Form (eAF) for non-CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 17 October 2024, 10:00 (CEST) to 17 October 2024, 11:30 (CEST)

Published: Mar 7, 2025 | Category: EMA | Name: EMA Events

Info session on web-based electronic Application Form (eAF) add package, Online, European Medicines Agency, Amsterdam, the Netherlands, from 18 July 2024, 11:00 (CEST) to 18 July 2024, 12:00 (CEST)

Published: Mar 7, 2025 | Category: EMA | Name: EMA Events

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - June 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 17 June 2025, 11:00 (CEST

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - June 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 17 June 2025, 11:00 (CEST) to 17 June 2025, 12:00 (CEST)

Published: Mar 7, 2025 | Category: EMA | Name: EMA Events

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - May 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 19 May 2025, 15:00 (CEST)

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - May 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 19 May 2025, 15:00 (CEST) to 19 May 2025, 16:00 (CEST)

Published: Mar 7, 2025 | Category: EMA | Name: EMA Events

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - April 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 29 April 2025, 11:00 (CE

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - April 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 29 April 2025, 11:00 (CEST) to 29 April 2025, 12:00 (CEST)

Published: Mar 7, 2025 | Category: EMA | Name: EMA Events

Minutes of the CHMP meeting 11-14 November 2024

Published: Mar 7, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes - PDCO minutes of the 12-15 November 2024 meeting

Published: Mar 5, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 March 2025, 11:00 (CET) to 6 March 2025, 11:30 (CET)

Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 March 2025, 11:00 (CET) to 6 March 2025, 11:30 (CET)

Published: Mar 3, 2025 | Category: EMA | Name: EMA Events

Clinical Trials Information System (CTIS) bitesize talk: End of transition period and notifications including serious breach, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 16 October 2024, 15:30 (CEST) to 16 October 2024,

Clinical Trials Information System (CTIS) bitesize talk: End of transition period and notifications including serious breach, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 16 October 2024, 15:30 (CEST) to 16 October 2024, 17:00 (CEST)

Published: Mar 3, 2025 | Category: EMA | Name: EMA Events

Clinical Trials Information System (CTIS) Bitesize Talk: Revised transparency rules and the new CTIS public portal, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 20 June 2024, 15:30 (CEST) to 20 June 2024, 17:00 (CEST)

Clinical Trials Information System (CTIS) Bitesize Talk: Revised transparency rules and the new CTIS public portal, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 20 June 2024, 15:30 (CEST) to 20 June 2024, 17:00 (CEST)

Published: Mar 3, 2025 | Category: EMA | Name: EMA Events

3Rs Working Party (3RsWP) plenary meeting - Public session on the 2025-2027 work plan, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 2 April 2024, 09:30 (CEST) to 2 April 2024, 10:30 (CEST)

3Rs Working Party (3RsWP) plenary meeting - Public session on the 2025-2027 work plan, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 2 April 2024, 09:30 (CEST) to 2 April 2024, 10:30 (CEST)

Published: Mar 3, 2025 | Category: EMA | Name: EMA Events

European Shortages Monitoring Platform (ESMP) workshop on application programming interface (API) for marketing authorisation holders (MAHs), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 March 2025, 14:00 (CET) to 24 M

European Shortages Monitoring Platform (ESMP) workshop on application programming interface (API) for marketing authorisation holders (MAHs), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 March 2025, 14:00 (CET) to 24 March 2025, 16:00 (CET)

Published: Feb 28, 2025 | Category: EMA | Name: EMA Events

Certificates Processing System: Demo & Q&A session for Industry stakeholders (H+V), Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 April 2025, 12:30 (CEST) to 10 April 2025, 13:00 (CEST)

Certificates Processing System: Demo & Q&A session for Industry stakeholders (H+V), Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 April 2025, 12:30 (CEST) to 10 April 2025, 13:00 (CEST)

Published: Feb 28, 2025 | Category: EMA | Name: EMA Events

Certificates Processing System: Demo & Q&A session for Industry stakeholders (H+V), Online, from 27 March 2025, 12:30 (CET) to 27 March 2025, 13:00 (CET)

Published: Feb 28, 2025 | Category: EMA | Name: EMA Events

Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) No 726/2004

Published: Feb 28, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Draft guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2

Published: Feb 28, 2025 | Category: EMA | Name: EMA Scientific Guidelines

Minutes of the CAT meeting 22-24 January 2025

Published: Feb 27, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations

Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations

Published: Feb 27, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 18 February 2025, 09:30 (CET) to 18 February 2025, 13:00 (CET)

Published: Feb 27, 2025 | Category: EMA | Name: EMA Events

Certificates Processing System: Demo & Q&A session for industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 March 2025, 12:30 (CET) to 13 March 2025, 13:00 (CET)

Certificates Processing System: Demo & Q&A session for industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 March 2025, 12:30 (CET) to 13 March 2025, 13:00 (CET)

Published: Feb 26, 2025 | Category: EMA | Name: EMA Events

Joint EC/HMA/EMA multi-stakeholder workshop on pharmacogenomics, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 September 2024, 09:00 (CEST) to 24 September 2024, 17:00 (CEST)

Joint EC/HMA/EMA multi-stakeholder workshop on pharmacogenomics, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 September 2024, 09:00 (CEST) to 24 September 2024, 17:00 (CEST)

Published: Feb 26, 2025 | Category: EMA | Name: EMA Events

Addendum to the Guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals

Published: Feb 26, 2025 | Category: EMA | Name: EMA Scientific Guidelines

Agenda - PDCO agenda of the 25-28 February 2025 meeting

Published: Feb 26, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Annex to 24-27 February 2025 CHMP Agenda

Published: Feb 24, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the CHMP meeting 24-27 February 2025

Published: Feb 24, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Review of transparency rules for the EU Clinical Trials Information System (CTIS)

EMA has opened a public consultation to review the Appendix, on disclosure rules, to the functional specifications for the EU portal and EU database to be audited for the…

Published: Feb 24, 2025 | Category: EMA | Name: EMA News

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

Published: Feb 24, 2025 | Category: EMA | Name: EMA Procedural Guidelines

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes

Published: Feb 24, 2025 | Category: EMA | Name: EMA Procedural Guidelines

European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications

Published: Feb 24, 2025 | Category: EMA | Name: EMA Procedural Guidelines

European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications: document with track changes

Published: Feb 24, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Orphan designation: Adeno-associated virus serotype 9 containing the human RPE65 gene inherited retinal dystrophy due to defects in the RPE65 gene, 16/01/2025 Positive

Published: Feb 24, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: N-(4-(4-amino-5-(3-fluoro-4-((4-methylpyrimidin-2-yl)oxy)phenyl)-7-methyl-7H-pyrrolo[2,3-d] pyrimidin-6-yl)phenyl)methacrylamide hydrochloride Treatment of biliary tract cancer, 10/11/2022 Positive

Orphan designation: N-(4-(4-amino-5-(3-fluoro-4-((4-methylpyrimidin-2-yl)oxy)phenyl)-7-methyl-7H-pyrrolo[2,3-d] pyrimidin-6-yl)phenyl)methacrylamide hydrochloride Treatment of biliary tract cancer, 10/11/2022 Positive

Published: Feb 24, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Arsenic trioxide Treatment of acute promyelocytic leukaemia, 13/12/2024 Positive

Published: Feb 24, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: human anti-promyostatin monoclonal antibody (apitegromab) Treatment of spinal muscular atrophy, 14/12/2018 Positive

Published: Feb 24, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Lomitapide Treatment of familial chylomicronaemia, 17/12/2010 Positive

Published: Feb 24, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues Treatment of familial chylomicronaemia syndrome, 19/07/2021 Po

Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues Treatment of familial chylomicronaemia syndrome, 19/07/2021 Positive

Published: Feb 24, 2025 | Category: EMA | Name: EMA Orphan

Agenda of the COMP meeting 3-5 December 2024

Published: Feb 21, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the COMP meeting 21-23 January 2025

Published: Feb 21, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Training on human variations web-based electronic application form (eAF) functionalities for CAPs and non-CAPs variations, Online, European Medicines Agency, Amsterdam, the Netherlands, from 27 February 2025, 10:30 (CET) to 27 February 2025, 12:30 (CET)

Training on human variations web-based electronic application form (eAF) functionalities for CAPs and non-CAPs variations, Online, European Medicines Agency, Amsterdam, the Netherlands, from 27 February 2025, 10:30 (CET) to 27 February 2025, 12:30 (CET)

Published: Feb 21, 2025 | Category: EMA | Name: EMA Events

Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin

Published: Feb 21, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Regulation (EU) 2024/568: Questions and answers clinic for the Human Industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 February 2025, 11:00 (CET) to 10 February 2025, 12:00 (CET)

Regulation (EU) 2024/568: Questions and answers clinic for the Human Industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 February 2025, 11:00 (CET) to 10 February 2025, 12:00 (CET)

Published: Feb 21, 2025 | Category: EMA | Name: EMA Events

Agenda – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) 26 February 2025

Published: Feb 21, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CVMP meeting 14-15 January 2025

Published: Feb 20, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Orphan designation: Rilzabrutinib Treatment of autoimmune haemolytic anaemia, 16/01/2025 Positive

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Clofutriben Treatment of Cushing's syndrome of endogenous origin, 16/01/2025 Positive

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: xevinapant Treatment of ovarian cancer, 11/11/2015 Withdrawn

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Adeno-associated virus serotype 5 vector encoding C1-esterase inhibitor Treatment of hereditary angioedema, 10/11/2022 Withdrawn

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Autologous CD34+ cells transfected with lentiviral vector containing the Wiskott-Aldrich syndrome protein gene (etuvetidigene autotemcel) Treatment of Wiskott-Aldrich syndrome, 07/10/2013 Withdrawn

Orphan designation: Autologous CD34+ cells transfected with lentiviral vector containing the Wiskott-Aldrich syndrome protein gene (etuvetidigene autotemcel) Treatment of Wiskott-Aldrich syndrome, 07/10/2013 Withdrawn

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: amitriptyline Treatment of erythromelalgia, 21/06/2022 Withdrawn

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Adeno-associated viral vector serotype 9 containing the human iduronate-2-sulfatase gene Treatment of mucopolysaccharidosis type II (Hunter's syndrome), 10/08/2015 Withdrawn

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Adeno-associated viral vector serotype 9 containing the human N-acetylglucosaminidase-alpha gene Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome), 24/01/2013 Withdrawn

Orphan designation: Adeno-associated viral vector serotype 9 containing the human N-acetylglucosaminidase-alpha gene Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome), 24/01/2013 Withdrawn

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector containing the human RAG1 gene Treatment of recombination-activating gene 1 deficient severe combined immunodeficiency, 26/03/2014 Positive

Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector containing the human RAG1 gene Treatment of recombination-activating gene 1 deficient severe combined immunodeficiency, 26/03/2014 Positive

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: zopapogene imadenovec Treatment of recurrent respiratory papillomatosis, 12/01/2024 Positive

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: N-(2-Methoxyethyl)-6-methyl-N-[(3-methyl-2-thienyl)methyl]-2-oxo-1,2-dihydropyridine-4-carboxamide Treatment of glycogen storage disease type IV, 16/01/2025 Positive

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: volixibat potassium Treatment of primary biliary cholangitis, 16/01/2025 Positive

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Allogenic umbilical cord-derived osteoblast cells Treatment of non-traumatic osteonecrosis, 16/01/2025 Positive

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Elraglusib Treatment of soft tissue sarcoma, 16/01/2025 Positive

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: [4-(Methyl-1H-pyrazol-4-yl)-benzyl]-(6[7-(3-pyrrolidin-1-yl-propoxy)-imidazo[1,2-a]pyridin-3-yl]-pyrimidin-4-yl]-amine Treatment of gastrointestinal stromal tumours, 16/01/2025 Positive

Orphan designation: [4-(Methyl-1H-pyrazol-4-yl)-benzyl]-(6[7-(3-pyrrolidin-1-yl-propoxy)-imidazo[1,2-a]pyridin-3-yl]-pyrimidin-4-yl]-amine Treatment of gastrointestinal stromal tumours, 16/01/2025 Positive

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Elraglusib Treatment of pancreatic cancer, 16/01/2025 Positive

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Alvelestat Treatment of congenital alpha-1 antitrypsin deficiency, 16/01/2025 Positive

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

Orphan designation: Camostat mesilate Treatment of chronic pancreatitis, 16/01/2025 Positive

Published: Feb 20, 2025 | Category: EMA | Name: EMA Orphan

DARWIN EU Advisory Board meeting: 3 May 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 May 2024, 13:00 (CEST) to 3 May 2024, 14:30 (CEST)

Published: Feb 20, 2025 | Category: EMA | Name: EMA Events

Minutes - DARWIN EU Advisory Board - 3 May 2024

Published: Feb 20, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Finding clinical trials with the ACT EU Trial Map, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 7 March 2025, 13:30 (CET) to 7 March 2025, 14:30 (CET)

Published: Feb 19, 2025 | Category: EMA | Name: EMA Events

Orphan designation: Humanised monoclonal antibody targeting B-cell maturation antigen conjugated with maleimidocaproyl monomethyl auristatin F Treatment of multiple myeloma, 16/10/2017 Withdrawn

Published: Feb 19, 2025 | Category: EMA | Name: EMA Orphan

European medicines agencies network strategy (EMANS) to 2028 webinar, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 13 February 2025, 13:00 (CET) to 13 February 2025, 17:00 (CET)

European medicines agencies network strategy (EMANS) to 2028 webinar, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 13 February 2025, 13:00 (CET) to 13 February 2025, 17:00 (CET)

Published: Feb 18, 2025 | Category: EMA | Name: EMA Events

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - 4 February 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 4 February 2025, 11:00 (CET) t

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - 4 February 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 4 February 2025, 11:00 (CET) to 4 February 2025, 11:45 (CET)

Published: Feb 18, 2025 | Category: EMA | Name: EMA Events

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

Published: Feb 18, 2025 | Category: EMA | Name: EMA Procedural Guidelines

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes

Published: Feb 18, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Agenda of the CAT meeting 19-21 February 2025

Published: Feb 18, 2025 | Category: EMA | Name: EMA Agenda and Minutes

ACT EU workshop on ICH E6 R3 (principles and Annex 1) , Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 19 February 2025, 09:30 (CET) to 20 February 2025, 14:00 (CET)

Published: Feb 18, 2025 | Category: EMA | Name: EMA Events

Agenda - ACT EU workshop on ICH E6 (R3)

Published: Feb 18, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Programme - EMA's Open Door Day

Published: Feb 18, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes - HMA-EMA joint Big Data Steering Group teleconference - 11 December 2024

Published: Feb 17, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the COMP meeting 18-19 February 2025

Published: Feb 17, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Fifth EMA/HMA Big Data Stakeholder Forum, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 28 November 2024, 09:30 (CET) to 28 November 2024, 17:30 (CET)

Published: Feb 17, 2025 | Category: EMA | Name: EMA Events

European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting, European Medicines Agency, Amsterdam, the Netherlands, from 1 April 2025 to 2 April 2025

European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting, European Medicines Agency, Amsterdam, the Netherlands, from 1 April 2025 to 2 April 2025

Published: Feb 17, 2025 | Category: EMA | Name: EMA Events

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 2: Format for the electronic submission of veterinary medicinal product information

Published: Feb 17, 2025 | Category: EMA | Name: EMA Procedural Guidelines

EMA earns certification for its environmental efforts

EMA’s environmental management system has been certified with the Eco-Management and Audit Scheme (EMAS), recognising the Agency’s commitment to environmental sustainability. EMAS…, The EMAS certification is an important acknowledgment of our efforts to strive for continuous improvement and reduce our environmental footprint. As an EU body, EMA takes its…, EMA protects the environment in several ways: the office building is environmentally certified with a BREEAM Excellent rating and an Energy Label A++. Procurement practices are…

Published: Feb 17, 2025 | Category: EMA | Name: EMA News

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-12 February 2025

CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a positive opinion for a marketing authorisation from Ceva Santé Animale for Vectormune…, Maximum residue limits Fluralaner (Salmonidae and other fin fish) - Summary opinion of the CVMP on the extension of maximum residue limitsAdoptedReference Number…

Published: Feb 14, 2025 | Category: EMA | Name: EMA News

Conversations on cancer - cervical cancer treatment innovation: a collaborative discussion , European Medicines Agency, Amsterdam, the Netherlands, from 14 January 2025, 16:00 (CET) to 14 January 2025, 17:00 (CET)

Conversations on cancer - cervical cancer treatment innovation: a collaborative discussion , European Medicines Agency, Amsterdam, the Netherlands, from 14 January 2025, 16:00 (CET) to 14 January 2025, 17:00 (CET)

Published: Feb 14, 2025 | Category: EMA | Name: EMA Events

Product Management Service (PMS) webinar : Unlocking Integration – MAH & Software Developers to explore PMS API Machine-to-Machine Connection, Online, European Medicines Agency, Amsterdam, the Netherlands, from 14 March 2025, 10:30 (CET) to 14 March 202

Product Management Service (PMS) webinar : Unlocking Integration – MAH & Software Developers to explore PMS API Machine-to-Machine Connection, Online, European Medicines Agency, Amsterdam, the Netherlands, from 14 March 2025, 10:30 (CET) to 14 March 2025, 12:00 (CET)

Published: Feb 14, 2025 | Category: EMA | Name: EMA Events

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2025

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines:…, Agenda Agenda of the PRAC meeting 10-13 February 2025DraftReference Number: EMA/PRAC/15940/2025 English (EN…, PRAC statistics: February 2025 , PRAC statistics: February 2025 English (EN) (108.7 KB - PDF)First published: 14/02/2025View, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association…, Ongoing referrals ProcedureStatusUpdateFinasteride- and dutasteride-containing medicinal products - referralUnder evaluationPRAC continued its…

Published: Feb 14, 2025 | Category: EMA | Name: EMA News

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 May 2025 to 16 May 2025

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 May 2025 to 16 May 2025

Published: Feb 14, 2025 | Category: EMA | Name: EMA Events

Training on human variations web-based electronic application form (eAF) functionalities for non-CAPs variations, Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 February 2025, 10:30 (CET) to 11 February 2025, 12:30 (CET)

Training on human variations web-based electronic application form (eAF) functionalities for non-CAPs variations, Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 February 2025, 10:30 (CET) to 11 February 2025, 12:30 (CET)

Published: Feb 13, 2025 | Category: EMA | Name: EMA Events

Quarterly System Demo – Q1 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 26 March 2025, 09:00 (CET) to 26 March 2025, 11:30 (CET)

Published: Feb 13, 2025 | Category: EMA | Name: EMA Events

EMA Veterinary Innovation Day, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 March 2025, 13:30 (CET) to 14 March 2025, 12:30 (CET)

Published: Feb 13, 2025 | Category: EMA | Name: EMA Events

Agenda - EMA Veterinary Innovation Day - March 2025

Published: Feb 13, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Regulation (EU) 2024/568: Questions and answers clinic for the Veterinary Industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 February 2025, 15:00 (CET) to 11 February 2025, 16:00 (CET)

Regulation (EU) 2024/568: Questions and answers clinic for the Veterinary Industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 February 2025, 15:00 (CET) to 11 February 2025, 16:00 (CET)

Published: Feb 13, 2025 | Category: EMA | Name: EMA Events

Minutes - PDCO minutes of the 10-13 December 2024 meeting

Published: Feb 13, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Implementation strategy of ICH Guideline M12 on drug interaction studies

Published: Feb 13, 2025 | Category: EMA | Name: EMA Scientific Guidelines

Agenda - European medicines agencies network strategy (EMANS) to 2028 - webinar

Published: Feb 12, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance

Published: Feb 12, 2025 | Category: EMA | Name: EMA Scientific Guidelines

Webinar on PMS Project Made Easy: Summary of activities and Practical Tips for SMEs, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 February 2025, 14:00 (CET) to 24 February 2025, 16:00 (CET)

Webinar on PMS Project Made Easy: Summary of activities and Practical Tips for SMEs, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 February 2025, 14:00 (CET) to 24 February 2025, 16:00 (CET)

Published: Feb 11, 2025 | Category: EMA | Name: EMA Events

Minutes of the COMP meeting 3-5 December 2024

Published: Feb 11, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Agenda of the CVMP meeting 11-13 February 2025

Published: Feb 11, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Pharmacovigilance Risk Assessment Committee (PRAC): 10 - 13 February 2025, European Medicines Agency, Amsterdam, the Netherlands, from 10 February 2025 to 13 February 2025

Published: Feb 10, 2025 | Category: EMA | Name: EMA Events

Agenda of the PRAC meeting 10-13 February 2025

Published: Feb 10, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Methylphenidate, prolonged-release tablet 18 mg, 27 mg, 36 mg and 54 mg and modified release capsule 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg product-specific bioequivalence guidance

Published: Feb 10, 2025 | Category: EMA | Name: EMA Scientific Guidelines

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 5 December 2024, 09:30 (CET) to 5 December 2024, 13:30 (CET)

Published: Feb 10, 2025 | Category: EMA | Name: EMA Events

Pharmacovigilance Risk Assessment Committee (PRAC): 25 - 28 November 2024, European Medicines Agency, Amsterdam, the Netherlands, from 25 November 2024 to 28 November 2024

Published: Feb 10, 2025 | Category: EMA | Name: EMA Events

Minutes of the PRAC meeting 25-28 November 2024

Published: Feb 10, 2025 | Category: EMA | Name: EMA Agenda and Minutes

ACT EU multi-stakeholder platform annual meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 22 October 2024, 09:30 (CEST) to 22 October 2024, 17:00 (CEST)

Published: Feb 10, 2025 | Category: EMA | Name: EMA Events

EMA establishes regular procedure for scientific advice on certain high-risk medical devices

EMA, in close collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice…

Published: Feb 10, 2025 | Category: EMA | Name: EMA News

EMA Open Door Day, European Medicines Agency, Amsterdam, the Netherlands, from 9 May 2025, 09:00 (CEST) to 9 May 2025, 16:45 (CEST)

Published: Feb 7, 2025 | Category: EMA | Name: EMA Events

European Shortages Monitoring (ESMP) - Question and answer clinic for marketing authorisation holders on shortage reporting via ESMP, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 February 2025, 10:00 (CET) to 25 Februa

European Shortages Monitoring (ESMP) - Question and answer clinic for marketing authorisation holders on shortage reporting via ESMP, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 February 2025, 10:00 (CET) to 25 February 2025, 11:00 (CET)

Published: Feb 7, 2025 | Category: EMA | Name: EMA Events

Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changes

Published: Feb 5, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)

Published: Feb 5, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – December 2025, European Medicines Agency, Amsterdam, the Netherlands, from 17 December 2025, 10:00 (CET) to 17 December 2025, 12:00 (CET)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – December 2025, European Medicines Agency, Amsterdam, the Netherlands, from 17 December 2025, 10:00 (CET) to 17 December 2025, 12:00 (CET)

Published: Feb 5, 2025 | Category: EMA | Name: EMA Events

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – November 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 November 2025, 10:00 (CET) to 19 November 2025, 12:00 (CET)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – November 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 November 2025, 10:00 (CET) to 19 November 2025, 12:00 (CET)

Published: Feb 5, 2025 | Category: EMA | Name: EMA Events

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – October 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 22 October 2025, 10:00 (CEST) to 22 October 2025, 12:00 (CEST)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – October 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 22 October 2025, 10:00 (CEST) to 22 October 2025, 12:00 (CEST)

Published: Feb 5, 2025 | Category: EMA | Name: EMA Events

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – September 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 September 2025, 10:00 (CEST) to 24 September 2025, 12:00 (CEST)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – September 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 September 2025, 10:00 (CEST) to 24 September 2025, 12:00 (CEST)

Published: Feb 5, 2025 | Category: EMA | Name: EMA Events

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – July 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 July 2025, 10:00 (CEST) to 23 July 2025, 12:00 (CEST)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – July 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 July 2025, 10:00 (CEST) to 23 July 2025, 12:00 (CEST)

Published: Feb 5, 2025 | Category: EMA | Name: EMA Events

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – June 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 June 2025, 10:00 (CEST) to 26 June 2025, 12:00 (CEST)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – June 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 June 2025, 10:00 (CEST) to 26 June 2025, 12:00 (CEST)

Published: Feb 5, 2025 | Category: EMA | Name: EMA Events

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – May 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 21 May 2025, 10:00 (CEST) to 21 May 2025, 12:00 (CEST)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – May 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 21 May 2025, 10:00 (CEST) to 21 May 2025, 12:00 (CEST)

Published: Feb 5, 2025 | Category: EMA | Name: EMA Events

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – April 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 29 April 2025, 10:00 (CEST) to 29 April 2025, 12:00 (CEST)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – April 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 29 April 2025, 10:00 (CEST) to 29 April 2025, 12:00 (CEST)

Published: Feb 5, 2025 | Category: EMA | Name: EMA Events

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – April 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 1 April 2025, 10:00 (CEST) to 1 April 2025, 12:00 (CEST)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – April 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 1 April 2025, 10:00 (CEST) to 1 April 2025, 12:00 (CEST)

Published: Feb 5, 2025 | Category: EMA | Name: EMA Events

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – February 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 February 2025, 10:00 (CET) to 26 February 2025, 12:00 (CET)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – February 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 February 2025, 10:00 (CET) to 26 February 2025, 12:00 (CET)

Published: Feb 5, 2025 | Category: EMA | Name: EMA Events

Clinical Trials Information System (CTIS) bitesize talk: Change of sponsor in CTIS, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 5 March 2025, 15:30 (CET) to 5 March 2025, 17:00 (CET)

Clinical Trials Information System (CTIS) bitesize talk: Change of sponsor in CTIS, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 5 March 2025, 15:30 (CET) to 5 March 2025, 17:00 (CET)

Published: Feb 5, 2025 | Category: EMA | Name: EMA Events

Twelfth Industry Standing Group (ISG) meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 28 March 2025, 09:00 (CET) to 28 March 2025, 14:00 (CET)

Published: Feb 5, 2025 | Category: EMA | Name: EMA Events

Questions and answers clinic on post-authorisation procedure management in IRIS, Online, from 8 January 2025, 14:00 (CET) to 8 January 2025, 15:00 (CET)

Published: Feb 4, 2025 | Category: EMA | Name: EMA Events

Webinar on reflection paper on the qualification of non-mutagenic impurities, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 March 2025, 13:00 (CET) to 6 March 2025, 15:00 (CET)

Webinar on reflection paper on the qualification of non-mutagenic impurities, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 March 2025, 13:00 (CET) to 6 March 2025, 15:00 (CET)

Published: Feb 3, 2025 | Category: EMA | Name: EMA Events

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - December 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 December 2024, 09:00 (CET) to 11 December 2024, 10:30 (CET)

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - December 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 December 2024, 09:00 (CET) to 11 December 2024, 10:30 (CET)

Published: Feb 3, 2025 | Category: EMA | Name: EMA Events

SPOR Status Update, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 22 January 2025, 10:00 (CET) to 22 January 2025, 12:30 (CET)

Published: Jan 31, 2025 | Category: EMA | Name: EMA Events

Guidance on Irish language derogation ending on 1 January 2022

Published: Jan 31, 2025 | Category: EMA | Name: EMA Procedural Guidelines

List of centrally authorised products with safety-related changes to the product information

Published: Jan 31, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Clinical Trials Information System (CTIS): Walk-in clinic - January 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 29 January 2025, 16:00 (CET) to 29 January 2025, 17:00 (CET)

Clinical Trials Information System (CTIS): Walk-in clinic - January 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 29 January 2025, 16:00 (CET) to 29 January 2025, 17:00 (CET)

Published: Jan 31, 2025 | Category: EMA | Name: EMA Events

Questions and answers clinic on post-authorisation procedure management in IRIS - 17 Jan 2025, Online, from 17 January 2025, 10:00 (CET) to 17 January 2025, 11:00 (CET)

Published: Jan 31, 2025 | Category: EMA | Name: EMA Events

Product Management Service (PMS) information day 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 21 May 2025, 09:00 (CEST) to 21 May 2025, 17:30 (CEST)

Published: Jan 31, 2025 | Category: EMA | Name: EMA Events

Clinical Trials Regulation becomes fully applicable

From today, all clinical trials in the European Union (EU), including ongoing trials that were approved under the previous legal framework, the Clinical Trials Directive (CTD),…

Published: Jan 31, 2025 | Category: EMA | Name: EMA News

Draft reflection paper on the use of information in European Union herbal monographs and assessment reports for borderline issues

Published: Jan 31, 2025 | Category: EMA | Name: EMA Public Consultations

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025

Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its January 2025 meeting.The CHMP recommended…, Positive recommendations on new medicines , Capvaxive Common name pneumococcal polysaccharide conjugate vaccine (21-valent)…, Datroway INN datopotamab deruxtecan Marketing authorisation applicant…, Tivdak INN tisotumab vedotin Marketing authorisation applicant…, Vimkunya INN Chikungunya vaccine (recombinant, adsorbed) Marketing authorisation…, Positive recommendations on new biosimilar medicines , Dyrupeg INN pegfilgrastim Marketing authorisation applicant…, Pavblu INN aflibercept Marketing authorisation applicant…, Skojoy INN aflibercept Marketing authorisation applicant…, Positive recommendation on new generic medicine , Eltrombopag Accord INN eltrombopag Marketing authorisation holder…, Positive recommendations on new therapeutic indications , Breyanzi INN lisocabtagene maraleucel / lisocabtagene maraleucel Marketing…, Imfinzi INN durvalumab Marketing authorisation holder…, Opdivo INN nivolumab Marketing authorisation holder…, Ronapreve INN casirivimab / imdevimab Marketing authorisation holder…, Rxulti INN brexpiprazole Marketing authorisation holder…, Sivextro INN tedizolid phosphate Marketing authorisation holder…, Slenyto INN melatonin Marketing authorisation holder…, Yervoy INN ipilimumab Marketing authorisation holder…, Positive opinions for medicines intended for use outside the EU , Ivermectin / Albendazole INN ivermectin / albendazole Marketing…, Withdrawal of initial marketing authorisation application , Datopotamab deruxtecan Daiichi Sankyo INN datopotamab Marketing authorisation…, Nugalviq INN Govorestat Marketing authorisation applicant…

Published: Jan 31, 2025 | Category: EMA | Name: EMA News

EMA workshop on the challenges in drug development, regulation and clinical practice for immunoglobulins, Online, European Medicines Agency, Amsterdam, the Netherlands, from 5 March 2025, 14:00 (CET) to 5 March 2025, 18:00 (CET)

EMA workshop on the challenges in drug development, regulation and clinical practice for immunoglobulins, Online, European Medicines Agency, Amsterdam, the Netherlands, from 5 March 2025, 14:00 (CET) to 5 March 2025, 18:00 (CET)

Published: Jan 31, 2025 | Category: EMA | Name: EMA Events

Member states contact points for translations review

Published: Jan 31, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5mg/ml

Published: Jan 31, 2025 | Category: EMA | Name: EMA Public Consultations

Aprepitant, hard capsules, 80mg, 125mg, 80+125mg and powder for oral suspension 125mg product-specific bioequivalence guidance

Published: Jan 31, 2025 | Category: EMA | Name: EMA Public Consultations

UPD refresher webinar for marketing authorisation holders on volume of sales submission, Online, from 5 December 2024, 10:00 (CET) to 5 December 2024, 11:00 (CET)

Published: Jan 31, 2025 | Category: EMA | Name: EMA Events

EMA/FVE webinar on veterinary prescription: conditions for using certain antimicrobials under the 'cascade', European Medicines Agency, Amsterdam, the Netherlands, from 16 January 2025, 14:00 (CET) to 16 January 2025, 15:00 (CET)

EMA/FVE webinar on veterinary prescription: conditions for using certain antimicrobials under the 'cascade', European Medicines Agency, Amsterdam, the Netherlands, from 16 January 2025, 14:00 (CET) to 16 January 2025, 15:00 (CET)

Published: Jan 30, 2025 | Category: EMA | Name: EMA Events

Product Management Service (PMS) webinar on Product User Interface (PUI) edit functionalities for industry users, Online, from 28 January 2025, 10:00 (CET) to 28 January 2025, 12:00 (CET)

Published: Jan 30, 2025 | Category: EMA | Name: EMA Events

Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - 13 February 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 February 2025, 10:30 (CET) to 13 February 20

Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - 13 February 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 February 2025, 10:30 (CET) to 13 February 2025, 11:15 (CET)

Published: Jan 30, 2025 | Category: EMA | Name: EMA Events

Draft reflection paper on the qualification of non-mutagenic impurities

Published: Jan 30, 2025 | Category: EMA | Name: EMA Public Consultations

One Health: EU agencies unite to tackle azole fungicide resistance in Aspergillus fungi

For the first time, the five EU health and environment agencies – EFSA (European Food Safety Authority), ECDC (European Centre for Disease Prevention and Control), ECHA (European…, This joint work carries great benefits for public health and shows the value of the One Health approach. By using the unique expertise of EU health organisations outside the…, One Health: main recommendationsTackling azole resistance in Aspergillus requires cross-sectoral collaboration. The One Health approach brought together EU experts from human and…, Video: Resistance to azole fungicides in AspergillusA video explains how the resistance to azole fungicides in Aspergillus is developed and its implications on public health.…

Published: Jan 30, 2025 | Category: EMA | Name: EMA News

Procedural advice for orphan medicinal product designation: Guidance for sponsors

Published: Jan 30, 2025 | Category: EMA | Name: EMA Procedural Guidelines

European Shortages Monitoring Platform fully operational for monitoring of shortages in the EU

The European Shortages Monitoring Platform (ESMP) is now live with the full scope of functionalities. This will enable marketing authorisation holders (MAHs) and national…

Published: Jan 28, 2025 | Category: EMA | Name: EMA News

Agenda - PDCO agenda of the 28-31 January 2025 meeting

Published: Jan 28, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Minutes of the CAT meeting 4-6 December 2024

Published: Jan 28, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Union product database: webinar for veterinary marketing authorisation holders on an industry dedicated read API, Online, from 27 February 2025, 11:00 (CET) to 27 February 2025, 12:00 (CET)

Published: Jan 28, 2025 | Category: EMA | Name: EMA Events

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 5: Technical specifications

Published: Jan 27, 2025 | Category: EMA | Name: EMA Procedural Guidelines

Agenda of the CHMP meeting 27-30 January 2025

Published: Jan 27, 2025 | Category: EMA | Name: EMA Agenda and Minutes

Annex to 27-30 January 2025 CHMP Agenda

Published: Jan 27, 2025 | Category: EMA | Name: EMA Agenda and Minutes

European Shortages Monitoring Platform (ESMP) training on crisis and MSSG-led preparedness reporting for marketing authorisation holders (MAHs), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 19 February 2025, 10:00 (CET) t

European Shortages Monitoring Platform (ESMP) training on crisis and MSSG-led preparedness reporting for marketing authorisation holders (MAHs), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 19 February 2025, 10:00 (CET) to 19 February 2025, 12:30 (CET)

Published: Jan 27, 2025 | Category: EMA | Name: EMA Events

EMA celebrates 30 years of progress in science and medicines in the European Union

EMA is celebrating 30 years of operations marking its evolving role at the centre of the European Union (EU) assessing and authorising safe, high-quality medicines for 450 million…, This is a European story to be proud of and to celebrate. We know there are challenges ahead of us, but our future is incredibly bright. I believe that with open communication…, EMA was set up in 1995 to manage the centralised procedure for the authorisation of medicines and to harmonise the work of existing national medicine regulatory bodies. Originally…, The original ambition was to centralise the evaluation of innovative medicines, so that, in the words of the French presidency at the time, ‘all patients in the EU could benefit…, A video with an overview of key milestones and achievements in the authorisation and safety monitoring of medicines for human and animal use in the EU is published today.,

Published: Jan 27, 2025 | Category: EMA | Name: EMA News

Clinical trials for medicines: Clinical Trials Regulations transitional arrangements

Published: Jul 15, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

In vitro diagnostic point-of-care test devices

Published: Jul 14, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Register to make submissions to the MHRA

Published: Jul 13, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

MHRA Innovation Office

Published: Jul 6, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Best practice in the labelling and packaging of medicines

Published: Jul 3, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Submit changes to labels and Patient Information Leaflets as a self-certification

Published: Jul 3, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Medicines: packaging, labelling and patient information leaflets

Published: Jul 1, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Warning statements for labels and leaflets of certain medicines

Published: Jul 1, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Best practice guidance on patient information leaflets

Published: Jul 1, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Innovation Accelerator

Published: Jun 29, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

MHRA Innovation Accelerator

Published: Jun 29, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

MHRA Innovation Office: guidance and support

Published: Jun 25, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Register of authorised online sellers of medicines in Northern Ireland

Published: Jun 24, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Advice for consumers

Published: Jun 18, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Opportunities for patients and the public to be involved in the work of the MHRA

Published: Jun 10, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

AI Airlock Sandbox Phase 2 Programme Report

Published: Jun 9, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Project Orbis

Published: May 22, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Medicines Pipeline data

Published: May 13, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Medical devices: ask for a regulatory advice meeting from the MHRA

Published: May 13, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: non-investigational medicinal products

Published: Apr 27, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: Good clinical practice inspections

Published: Apr 27, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: Notification of Serious Breaches of GCP or the trial protocol

Published: Apr 27, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Formulating responses to GCP inspection findings

Published: Apr 27, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: collection, verification and reporting of safety events

Published: Apr 27, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

National AI Commission: Ask Me Anything

Published: Apr 17, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: Compliance with ICH E6 good clinical practice (GCP) in the United Kingdom

Published: Apr 16, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: roles and responsibilities

Published: Apr 16, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

RSV Vaccine Factsheet – Information for Patients, Parents and Carers

Published: Apr 15, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: Declaration of Helsinki and Clinical Trial Regulations alignment

Published: Apr 14, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: Archiving and retention of clinical trial records

Published: Apr 14, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Environmental Risk Assessments in medicines

Published: Apr 1, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Get medicines to NHS patients earlier via the MHRA-NICE aligned pathway

Published: Apr 1, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical investigations in Northern Ireland

Published: Mar 31, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical investigations in Great Britain

Published: Mar 31, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical investigations: compiling a submission

Published: Mar 31, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Approving clinical investigations

Published: Mar 31, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical investigations for electrically powered devices

Published: Mar 30, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical investigations: biological safety assessments

Published: Mar 30, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical investigations: investigators' responsibilities

Published: Mar 30, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical investigations: statistical considerations

Published: Mar 30, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Medical devices that need a clinical investigation

Published: Mar 30, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: guidance on quality and risk proportionality

Published: Mar 27, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: guidance on compliance with ICH E6 good clinical practice (GCP) in the United Kingdom

Published: Mar 27, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines

Published: Mar 25, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

MHRA approach to medicines using non-animal methods

Published: Mar 25, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Meningitis – Patient Factsheet

Published: Mar 20, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Improving Patient Information

Published: Mar 18, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: good manufacturing practice and radiopharmaceutical investigational medicinal products

Published: Mar 9, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

COVID-19 test approval: how to apply

Published: Mar 6, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Paclitaxel drug-coated balloons and drug-eluting stents

Published: Mar 3, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

MHRA Portal: register to submit forms

Published: Mar 2, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Contact the MHRA

Published: Feb 27, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Strengthening supply chain cyber security at the MHRA

Published: Feb 26, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Medicines: Get integrated scientific advice from the MHRA and NICE

Published: Feb 20, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Get more help to apply for medicines Integrated Scientific Advice (ISA)

Published: Feb 20, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

A guide to defective medicinal products

Published: Feb 16, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Timelines for acceptance of CE marked medical devices in Great Britain (GB)

Published: Feb 16, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Good pharmacovigilance practice (GPvP)

Published: Feb 9, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Updates to CIR 520/2012 – Information for UK Marketing Authorisation Holders

Published: Feb 9, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Find product information about medicines

Published: Jan 22, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

International Council for Harmonisation (ICH) E6R3 Annotations

Published: Jan 12, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Common issues identified during clinical trial applications

Published: Jan 12, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Archiving and retention of clinical trial records

Published: Jan 12, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Declaration of Helsinki and Clinical Trial Regulations alignment

Published: Jan 12, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical Trials Regulations enforcement provisions

Published: Jan 12, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

Operational Information Sharing

Published: Jan 2, 2026 | Category: MHRA | Name: MHRA Guidance and Regulations

MMRV Vaccine Factsheet – Information for Parents and Caregivers

Published: Dec 22, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medical devices: legal requirements for specific medical products

Published: Dec 17, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Health Institution Exemption for general medical devices

Published: Dec 17, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medical devices: conformity assessment and the UKCA mark

Published: Dec 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

In Vitro Diagnostic roadmap

Published: Dec 15, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medical devices: get regulatory advice from the MHRA

Published: Dec 3, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Vaccine safety – patient factsheet

Published: Dec 2, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Centres of Excellence for Regulatory Science and Innovation (CERSIs)

Published: Dec 2, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Access Generic Medicines Work Sharing Initiative

Published: Dec 1, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Isotretinoin: an expert review of suspected psychiatric and sexual side effects

Published: Nov 3, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Herbal medicines granted a traditional herbal registration (THR)

Published: Oct 28, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Apply for a licence to market a medicine in the UK

Published: Oct 23, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Borderline products: how to tell if your product is a medicine

Published: Oct 17, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Variations to marketing authorisations (MAs)

Published: Oct 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medicines: apply for a variation to your marketing authorisation

Published: Oct 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

AI Airlock Sandbox Pilot Programme Report

Published: Oct 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

AI Airlock Phase 2 Cohort

Published: Oct 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

AI Airlock Simulation Workshops

Published: Oct 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medicines marketing authorisation: change of ownership

Published: Oct 2, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials that include an in vitro diagnostic device

Published: Oct 1, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Request a MHRA speaker at an event or conference

Published: Sep 18, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Apply for manufacturer or wholesaler of medicines licences

Published: Sep 12, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medical devices: Standardised format for the post market surveillance report

Published: Sep 5, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Make a payment to MHRA

Published: Sep 2, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Cosmetic Breast Augmentation Risk Awareness Tool

Published: Aug 26, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Breast implants – patient perception of risk research

Published: Aug 25, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: apply for authorisation in the UK

Published: Aug 22, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Route B substantial modification pilot

Published: Aug 17, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Cancel a medicine's marketing authorisation or other licence

Published: Aug 14, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Project Orbis

Published: Aug 12, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Report on Adverse Event (AE) reporting in digital mental health technologies (DMHTs) and the development of updates to regulatory guidance

Published: Aug 1, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Statement of Policy Intent: Early Access to Innovative Medical Devices

Published: Jul 30, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

The Yellow Card scheme: guidance for healthcare professionals, patients and the public

Published: Jul 24, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medicines: Marketing Authorisation Holders' submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing

Published: Jul 17, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medical devices: Standardised format for the periodic safety update report

Published: Jul 2, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Types of application for marketing authorisations (legal basis of applications)

Published: Jun 30, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: collection, verification, & reporting of safety events

Published: Jun 25, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials: Non-investigational medicinal products

Published: Jun 25, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials regulations: transitional arrangements

Published: Jun 25, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: modifying a clinical trial approval

Published: Jun 25, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: ending a clinical trial

Published: Jun 25, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: notifiable trials

Published: Jun 25, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: labelling

Published: Jun 25, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: expert advice

Published: Jun 25, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: apply for approval in the UK

Published: Jun 25, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

AI Airlock Background

Published: Jun 23, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

AI Airlock Phase 2 application

Published: Jun 23, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Electronic Common Technical Document (eCTD) submissions update

Published: Jun 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Field safety notices: guidance for manufacturers

Published: Jun 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Device specific vigilance guidance: Cardiac Implantable Electronic Devices (CIEDs)

Published: Jun 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Device specific vigilance guidance: Artificial Heart Valves

Published: Jun 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Field safety notice (FSN): what it is and why it's important

Published: Jun 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Device specific vigilance guidance: Inferior vena cava (IVC) filters

Published: Jun 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medical devices: post-market surveillance requirements

Published: Jun 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medical devices: examples of reportable incidents

Published: Jun 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Custom-made medical devices in Great Britain

Published: Jun 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medical devices: periodic safety update report

Published: Jun 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Device specific vigilance guidance: Coronary Stents and associated delivery systems

Published: Jun 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Decentralised manufacture: The designation step

Published: Jun 10, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Decentralised Manufacture: Marketing Authorisation application

Published: Jun 10, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Decentralised Manufacture: UK Guideline of Good Pharmacovigilance Practices

Published: Jun 10, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Decentralised Manufacture: Labelling

Published: Jun 10, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Decentralised manufacture: UK Guideline on Good Manufacturing Practice (GMP)

Published: Jun 10, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Decentralised manufacture: Clinical Trial Authorisation (CTA) and Good Clinical Practice (GCP)

Published: Jun 10, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Human medicines Modular Manufacture and Point of Care regulations 2025: Overview

Published: Jun 10, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Valproate – reproductive risks

Published: Jun 10, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

MORE Submissions - user reference guide

Published: Jun 10, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Regulation of medical devices in Northern Ireland

Published: Jun 9, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

MORE Registrations - user reference guide

Published: Jun 9, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Borderline products: medical devices and other products

Published: Jun 9, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Documentation for implementation of data requirements under the new Post-Market Surveillance regulations

Published: Jun 8, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

GLP-1 medicines for weight loss and diabetes: what you need to know

Published: Jun 4, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Regulatory considerations for therapeutic use of bacteriophages in the UK

Published: Jun 4, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

RegulatoryConnect

Published: Jun 4, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Disapplication of Falsified Medicines Directive Safety Features: Requirements for Parallel Imports

Published: Jun 3, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Chapter 2 - Product type guidance - Great Britain

Published: Jun 1, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Chapter 2 - Product type guidance - Northern Ireland

Published: Jun 1, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

E-cigarette and vape advice for retailers / producers

Published: Jun 1, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Assistive technology: definitions, examples and safe use

Published: May 23, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions

Published: May 19, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Rules for the sale, supply and administration of medicines

Published: May 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

MORE implementation

Published: May 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Manufacturer’s Online Reporting Environment (MORE)

Published: May 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Register a homeopathic medicine

Published: May 14, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

International Recognition Procedure

Published: May 13, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medicines: apply for a parallel import licence

Published: May 12, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

The Northern Ireland MHRA Authorised Route (NIMAR)

Published: May 9, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Risk minimisation measures for medicines

Published: Apr 16, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Advertise your medicines

Published: Apr 11, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

MHRA phase I accreditation scheme

Published: Apr 8, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medicines that you cannot export from the UK or hoard

Published: Apr 7, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Submission and assessment timetables for innovative medicines applications

Published: Apr 2, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

National assessment procedure for medicines

Published: Apr 2, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medical devices: information for patients

Published: Apr 2, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Register for the Distance Selling logo

Published: Apr 1, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Established medicines: marketing authorisation application changes

Published: Apr 1, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Guidance on the handling of applications for Centrally Authorised Products (CAPs)

Published: Apr 1, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Export drugs and medicines: special rules

Published: Apr 1, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Periodic Safety Update Reports (PSURs) for medicinal products

Published: Apr 1, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Early Access to Medicines Scheme: Overview

Published: Apr 1, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Early Access to Medicines Scheme - Information for Applicants

Published: Apr 1, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medicines: register as a broker

Published: Apr 1, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

MHRA fees

Published: Apr 1, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Exceptional Use Authorisation

Published: Mar 31, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Blue Guide: advertising and promoting medicines

Published: Mar 28, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical Trials Regulations webinar recordings

Published: Mar 28, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Breast implant associated anaplastic large cell lymphoma (BIA-ALCL)

Published: Mar 27, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Safety communications concerning medicines, medical devices and other healthcare products

Published: Mar 25, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medicines: register to manufacture, import or distribute active substances

Published: Mar 25, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Supplying authorised medicines to Northern Ireland

Published: Mar 20, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

The Innovative Devices Access Pathway (IDAP)

Published: Mar 17, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Good clinical practice for clinical trials

Published: Mar 13, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Export medical devices

Published: Mar 13, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Register of brokers authorised to deal in human medicines

Published: Mar 11, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medicines: terminated and cancelled manufacturing and wholesale dealer licences

Published: Mar 11, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Apply to release a vaccine or a blood product to market

Published: Mar 11, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Windsor Framework explainer

Published: Mar 11, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Reference medicinal products (RMPs)

Published: Mar 11, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Conditional marketing authorisations, exceptional circumstances MAs, scientific advice

Published: Mar 11, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Rolling review for marketing authorisation applications

Published: Mar 11, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Marketing authorisation applications referred under Article 29

Published: Mar 11, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Orphan medicinal products

Published: Mar 11, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

UK parallel import licences following agreement of the Windsor Framework

Published: Mar 11, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework

Published: Mar 11, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Pharmacovigilance following agreement of the Windsor Framework

Published: Mar 11, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Advertising and Promotion following agreement of the Windsor Framework

Published: Mar 11, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

UK-wide licensing for human medicines

Published: Mar 7, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Blood: authorisations and safety reporting

Published: Mar 5, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Good laboratory practice (GLP) for safety tests on chemicals

Published: Mar 4, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Format and content of applications for agreement or modification of a Paediatric Investigation Plan

Published: Feb 28, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

AI Airlock pilot cohort

Published: Feb 28, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Licensing plasma master files and vaccine antigen master files

Published: Feb 27, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Advanced therapy medicinal products: regulation and licensing in UK

Published: Feb 27, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Guidance on the licensing of biosimilar products

Published: Feb 27, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Implementation of medical devices future regime

Published: Feb 26, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical investigations guidance

Published: Feb 20, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medicines: reclassify your product

Published: Feb 20, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Wholesalers & manufacturers guidance following agreement of the Windsor Framework

Published: Feb 20, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medical devices: UK approved bodies

Published: Feb 19, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Register medical devices to place on the market

Published: Feb 17, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Registration of reusable or upclassified Class I devices and/or expiring CE certificates

Published: Feb 17, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Registration of in vitro diagnostic devices with expiring CE certificates

Published: Feb 17, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Safety Public Assessment Reports

Published: Feb 13, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Completed paediatric studies: submission, processing and assessment

Published: Feb 13, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Importing investigational medicinal products into Great Britain from approved countries

Published: Feb 12, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Category lists following implementation of the Windsor Framework

Published: Feb 11, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA

Published: Feb 7, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Clinical trials for medicines: manage your authorisation, report safety issues

Published: Feb 6, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Decision tree for navigating nanotechnology-based products for medical application

Published: Feb 5, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Software and artificial intelligence (AI) as a medical device

Published: Feb 3, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Digital mental health technology: qualification and classification

Published: Feb 3, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

COVID-19 test validation approved products

Published: Feb 3, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Current approaches to product marking

Published: Feb 3, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Regulating medical devices in the UK

What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.

Published: Jan 31, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Access New Active Substance and Biosimilar Work Sharing Initiatives

The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access p…

Published: Jan 31, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Medicines: get scientific advice from MHRA

A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.

Published: Jan 31, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

UK-wide licensing for human medicines: supplementary guidance

Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.

Published: Jan 31, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Innovative Licensing and Access Pathway (ILAP)

The Innovative Licensing and Access Pathway (ILAP) is focussed on getting the most transformative new medicines, to patients in the UK health system more quickly.

Published: Jan 30, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Notification of intent to import an unlicensed medicinal product

How to submit a notification of intent to import an unlicensed medicine to the MHRA.

Published: Jan 29, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Supply unlicensed medicinal products (specials)

Guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered products, including cannabis-based products for medicinal use in humans (CBPMs), known as 'specials'

Published: Jan 29, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Import a human medicine

Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.

Published: Jan 29, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

MHRA Graduate Scheme

Information about the MHRA's Graduate Scheme and how to apply.

Published: Jan 28, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

Drug Safety Update: monthly PDF newsletter

Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines

Published: Jan 28, 2025 | Category: MHRA | Name: MHRA Guidance and Regulations

AIFA pubblica il Terzo Position Paper sui farmaci biosimilari: focus su intercambiabilità, "switch informato" e sostenibilità del SSN

Il nuovo testo è stato approvato dalla Commissione Scientifica ed Economica (CSE) dell'AIFA, condiviso nell'ambito del Tavolo AIFA/Regioni.

Published: Apr 29, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro OPDIVO / YERVOY PRIMA LINEA

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 29.04.2026 è possibile utilizzare il medicinale OPDIVO in associazione a YERVOY, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Apr 29, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web Registro di monitoraggio OPDIVO Carcinoma Uroteliale

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 29/04/2026 è possibile utilizzare il medicinale OPDIVO mediante registro di monitoraggio per una specifica indicazione ammessa alla rimborsabilità.

Published: Apr 29, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web Registro di monitoraggio OPDIVO ADIUVANTE Carcinoma Uroteliale

Published: Apr 29, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Registro NUBEQA

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che,  a partire dal 29.04.2026, terminerà il monitoraggio del Registro di monitoraggio di NUBEQA per una specifica indicazione terapeutica.

Published: Apr 29, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro DARZALEX (MM)

Si informano gli utenti dei Registri dei farmaci sottoposti a monitoraggio che, a partire dal 29.04.2026, sono stati apportati aggiornamenti al Registro Darzalex (daratumumab) per il mieloma multiplo.

Published: Apr 29, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web Registro di monitoraggio DARZALEX VRD 1L MM

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 29/04/2026, è possibile utilizzare il medicinale DARZALEX mediante registro di monitoraggio per una indicazione ammessa alla rimborsabilità.

Published: Apr 29, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

List of class A and H medicinal products at 30 October 2025

AIFA makes available, to healthcare professionals, a list of class A and H medicinal products dispensed by the National Health Service, sorted by active ingredient and trade name.

Published: Apr 29, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Apr 29, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi politici, di amministrazione, di direzione o di governo - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Published: Apr 29, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Sunset Clause - Warning di prossima decadenza del 28 aprile 2026

La comunicazione costituisce un pre-avviso di decadenza e contiene un elenco dei medicinali in potenziale decadenza per mancata commercializzazione.

Published: Apr 28, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Sunset Clause - nuove modalità operative

Si informa che, dal 1° gennaio 2026, la competenza in materia di Sunset Clause è stata attribuita all’Ufficio Procedure Post Autorizzazione (UPPA).

Published: Apr 28, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 24/04/2026.

Published: Apr 27, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esiti riunione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile gli esiti dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 13-17 aprile 2026.

Published: Apr 24, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Farmaci per l’Alzheimer: audite in CdA società di neurologia e associazioni dei pazienti

L’iniziativa si inserisce nel più ampio quadro delle politiche di partecipazione e ascolto attivo degli stakeholder promosse dall'Agenzia.

Published: Apr 24, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Aggiornamento Registro MULTIFARMACO PPP, per i farmaci sottoposti a programma di prevenzione della gravidanza

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che,  a partire dal 24/04/2026, è aggiornato il Registro Multifarmaco PPP (Programma di Prevenzione della Gravidanza) con l’inserimento dell’indicazione rimborsabile ai sensi della legge 648/96.

Published: Apr 24, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Via libera dal CdA di AIFA alla rimborsabilità di 4 nuovi medicinali, 9 estensioni di indicazioni e 6 equivalenti

Tra i medicinali che saranno rimborsati, un farmaco orfano per la distrofia muscolare di Duchenne e nuovi farmaci e indicazioni in ambito oncologico.

Published: Apr 24, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Aggiornamento degli elenchi dei farmaci innovativi e degli agenti antinfettivi al 31/03/2026

Disponibili i report di valutazione per il riconoscimento dell’innovatività.

Published: Apr 23, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Organismo Indipendente di Valutazione della Performace - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Organismo Indipendente di Valutazione della Performace".

Published: Apr 23, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Comunicazione AIFA su Barbesaclone 25 mg

Nuove e importanti informazioni relative alla produzione e alla distribuzione del medicinale a denominazione generica Barbesaclone 25mg compresse rivestite - PROROGA SCADENZA.

Published: Apr 22, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso relativo all’attivazione di un comando obbligatorio presso l’Agenzia Italiana del Farmaco

Avviso relativo all’attivazione di un comando obbligatorio presso l’Agenzia Italiana del Farmaco per n. 1 funzionario con competenze tecnico strumentali, in possesso di lauree in ingegneria e architettura.

Published: Apr 22, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Tipologie di procedimenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Tipologie di procedimenti".

Published: Apr 22, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Medicine Use: 2024 Regional Reports Now Available Online

AIFA has published the Regional Reports on Medicine Consumption, which provide an analytical and detailed overview of medicine use within each Region during 2024.

Published: Apr 21, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Revisione delle Note AIFA: abrogate le Note 11 e 84

Le determine di abrogazione sono state pubblicate in GU l'11 aprile 2026.

Published: Apr 20, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

From one-size-fits-all treatments to personalised care: the revolution in precision medicine

The new AIFA report examines the clinical and economic impact of targeted therapies and prescriptomics

Published: Apr 17, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 17/04/2026.

Published: Apr 17, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi di collaborazione o consulenza - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi di collaborazione o consulenza".

Published: Apr 16, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Incarichi a dipendenti AIFA - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Incarichi a dipendenti AIFA".

Published: Apr 16, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro ASPAVELI

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 16.04.2026 è aggiornato il registro di ASPAVELI per una specifica indicazione terapeutica.

Published: Apr 16, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro FABHALTA

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 16.04.2026 è aggiornato il registro di FABHALTA per una specifica indicazione terapeutica.

Published: Apr 16, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro VOYDEYA

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 16.04.2026 è aggiornato il registro di VOYDEYA per una specifica indicazione terapeutica.

Published: Apr 16, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA updates the Transparency Lists

AIFA has published the updated Transparency Lists of generic medicines together with the related reference prices, updated at 15 April 2026.

Published: Apr 15, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Apr 15, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web Registro di monitoraggio TEVIMBRA OSCC

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 14/04/2026 è possibile utilizzare il medicinale TEVIMBRA mediante registro di monitoraggio per una specifica indicazione ammessa alla rimborsabilità.

Published: Apr 14, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web Registro di monitoraggio TEVIMBRA G/GEJ

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che,  a partire dal 14/04/2026 è possibile utilizzare il medicinale TEVIMBRA mediante registro di monitoraggio per una specifica indicazione ammessa alla rimborsabilità.

Published: Apr 14, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Medicine Shortage Communication on Holoxan (ifosfamide)

Manufacturing issues have caused an interruption in the manufacturing and release of medicinal product Holoxan (ifosfamide) 1 g powder for solution for injection - 1 vial MA n. 023779061, resulting in a shortage (quota distribution) expected to continue until Q1 2027.

Published: Apr 13, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Medicine Shortage Communication on Endoxan (ciclofosfamide)

supply shortage: Endoxan (cyclophosphamide) 500 mg powder for solution for injection - 1 vial MA n. 015628074 and Endoxan (cyclophosphamide) 1 g powder for solution for injection - 1 vial MA n. 015628086.

Published: Apr 13, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 10/04/2026.

Published: Apr 10, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Meeting highlights from PRAC ( 7- 10 April 2026)

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2026.

Published: Apr 10, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 13-17 aprile 2026.

Published: Apr 10, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Apr 10, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il rinnovo di incarichi di fascia retributiva S2/S3, diversi dalla struttura complessa, ai dirigenti sanitari dell’AIFA

Considerata la previsione di cui all’art. 30, comma 5, del vigente Regolamento di funzionamento e ordinamento del personale dell'Agenzia, risulta necessario procedere ai rinnovi di incarichi dirigenziali sanitari.

Published: Apr 10, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Revisionate le Linee Guida relative alle immunoglobuline umane normali per via sottocutanea e intramuscolare

Si è concluso, nell’ambito dell’attività dell’Haematology Working Party (HAEMWP) dell’EMA, il lavoro di aggiornamento e revisione delle Linee Guida relative alle immunoglobuline umane normali per via sottocutanea e intramuscolare.

Published: Apr 9, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

L'uso degli antibiotici in Italia - Rapporto Nazionale anno 2024

Nel 2024 quasi 4 cittadini su 10 hanno ricevuto almeno una prescrizione di antibiotici, con una prevalenza d’uso nei primi quattro anni di vita e negli over 85.

Published: Apr 9, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Regulations for AIFA Incontra and AIFA Ascolta Approved

The Agency strengthens dialogue with stakeholders and promotes listening and transparency.

Published: Apr 8, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Attivazione web e pubblicazione schede di monitoraggio - Registro RYBREVANT

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 04/04/2026 è possibile utilizzare il medicinale RYBREVANT, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Apr 7, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro RYBREVANT

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 04/04/2026 è aggiornato il Registro di RYBREVANT dedicato al monitoraggio di una specifica indicazione terapeutica.

Published: Apr 7, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro CARVYKTI

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 04/04/2026 è possibile utilizzare il medicinale CARVYKTI, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Apr 7, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento scheda Multifarmaco di monitoraggio semplificato intravitreali anti VEGF - BAIAMA

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 04.04.2026 è possibile selezionare, nella scheda multifarmaco di monitoraggio semplificato antiVEGF IVT, il medicinale BAIAMA (aflibercept) per quattro specifiche indicazioni terapeutiche.

Published: Apr 7, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 03/04/2026.

Published: Apr 3, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Apr 2, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di posti di funzione dirigenziale di livello non generale di direzione dell’Ufficio del sistema informativo del farmaco

Si procede all’attivazione della procedura di interpello per il conferimento dell’incarico dirigenziale di direzione dell’Ufficio del sistema informativo del farmaco.

Published: Apr 2, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro YORVIPATH

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 02/04/2026 è possibile utilizzare il medicinale YORVIPATH, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Apr 2, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA executives on institutional mission to Japan for the first time

The President of the Italian Medicines Agency, Robert Nisticò, led a delegation – which also included Board member Emanuele Monti and Dr Armando Magrelli from the International Relations Office – on an official visit to Japan.

Published: Apr 2, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Aggiornamento Tariffe ISTAT

Si avvisano le Aziende che, dal 1° aprile 2026, le tariffe riferibili al D.M. 6 dicembre 2016, concernente “Aggiornamento delle tariffe vigenti e determinazione delle tariffe relative a prestazioni non ancora tariffate”, sono automaticamente aggiornate sulla base dell'indice ISTAT del costo della vita riferito al mese di dicembre 2025,

Published: Apr 1, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Jelena Ivanovic (AIFA) eletta Co-Chair del Sottogruppo per l'Identificazione delle Tecnologie Sanitarie Emergenti in Europa

Il 26 marzo si è svolto a Bruxelles il ventitreesimo incontro del Sottogruppo per l'Identificazione delle Tecnologie Sanitarie Emergenti (Subgroup for the Identification of Emerging Health Technologies - EHT SG).

Published: Apr 1, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Apr 1, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

EMA raccomanda la restrizione delle indicazioni terapeutiche del medicinale Tecovirimat SIGA

Il medicinale non ha dimostrato efficacia nel trattamento dell’infezione virale mpox in studi clinici controllati e randomizzati.

Published: Mar 31, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento degli elenchi dei farmaci innovativi e degli agenti antinfettivi al 28/02/2026

Disponibili i report di valutazione per il riconoscimento dell’innovatività.

Published: Mar 31, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti dirigenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti dirigenti".

Published: Mar 30, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 27/03/2026.

Published: Mar 27, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Levamisole: the PRAC recommendation for withdrawal from the EU market has been confirmed

The (CMDh) endorsed the recommendation made by EMA’s safety committee (PRAC) to withdraw medicines containing levamisole from the European Union (EU).

Published: Mar 27, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Biosimilari: webinar AIFA su Terzo Position Paper

Si terrà da remoto il 9 aprile dalle 10:30 alle 13:30 per illustrare i contenuti della nuova versione e favorire un confronto diretto con gli stakeholder.

Published: Mar 27, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esiti runione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile gli esiti dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 16-20 marzo 2026.

Published: Mar 27, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro DUVYZAT

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 27/03/2026 è possibile utilizzare il medicinale DUVYZAT, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Mar 27, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web Registro di monitoraggio JAYPIRCA LLC

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 27/03/2026 è possibile utilizzare il medicinale JAYPIRCA mediante registro di monitoraggio per una specifica indicazione ammessa alla rimborsabilità.

Published: Mar 27, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro KEYTRUDA RCC

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 26.03.2026 è aggiornato il registro di KEYTRUDA per una specifica indicazione terapeutica.

Published: Mar 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro FABHALTA C3G

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 26/03/2026 è possibile utilizzare il medicinale FABHALTA, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Mar 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e aggiornamento schede di monitoraggio - Registro PALFORZIA

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 26/03/2026 è possibile utilizzare il medicinale PALFORZIA, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Mar 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registri RETSEVMO

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 26/03/2026 sono aggiornati i Registri di RETSEVMO dedicati al monitoraggio di quattro specifiche indicazioni terapeutiche rimborsate.

Published: Mar 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti dirigenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti dirigenti".

Published: Mar 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Mar 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Come difendersi dalle false "cure miracolose": le raccomandazioni di AIFA

Per evitare il rischio di frodi e proteggersi da presunte “cure miracolose” a base di cellule staminali, AIFA invita i pazienti e i loro familiari a seguire alcune importanti raccomandazioni.

Published: Mar 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Prevenzione della Corruzione - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Prevenzione della Corruzione".

Published: Mar 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Piano e Relazione sulla performance - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Piano e Relazione sulla performance".

Published: Mar 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Piano triennale per prevenzione della corruzione e della trasparenza - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Piano triennale per prevenzione della corruzione e della trasparenza".

Published: Mar 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Via libera dal CdA alla rimborsabilità di un nuovo farmaco, di 7 estensioni di indicazioni terapeutiche e di 3 equivalenti

Tra i medicinali che saranno rimborsati, sono compresi nuove indicazioni per il trattamento del cancro alla prostata metastatico, del mieloma multiplo di nuova diagnosi e dell’infezione da virus dell’epatite delta (HDV) e il farmaco per la profilassi pre-esposizione dell’infezione HIV-1.

Published: Mar 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Mar 25, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

CCNCE: nuova versione dello schema di contratto per la sperimentazione clinica sui medicinali

Il CCNCE ha pubblicato la versione aggiornata dello schema di “Contratto per la conduzione della sperimentazione clinica su medicinali" (versione 3 del 28(/01/2026).

Published: Mar 25, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Negoziazione dei farmaci: via alle nuove procedure "semplificate" e "fast track"

L’obiettivo è ridurre i tempi dei procedimenti di ammissione alla rimborsabilità dei farmaci, assicurando la sostenibilità economica per il SSN.

Published: Mar 24, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

AIFA and FIASO: a strategic alliance for patient safety, appropriate care and the sustainability of the NHS

Building a stable framework aimed at improving the quality of care, safeguarding patient safety and ensuring the long-term sustainability of the National Health Service: this is the shared commitment reaffirmed by the leaders of AIFA and FIASO (Italian Federation of Local Health and Hospital Authorities) during the meeting held at the Agency’s headquarters.

Published: Mar 24, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Aggiornamento delle istruzioni per la richiesta di rinnovo dell’Autorizzazione all’Importazione Parallela (AIP)

Si comunica che, nella pagina "Modulistica Certificazioni e Importazioni parallele", è disponibile, nella sezione “Istruzioni e modulistica Importazioni parallele”, l’aggiornamento delle istruzioni e della modulistica per la presentazione delle istanze di rinnovo dei medicinali di importazione parallela.

Published: Mar 23, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 20/03/2026.

Published: Mar 20, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Tipologie di procedimenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Tipologie di procedimenti".

Published: Mar 19, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi politici, di amministrazione, di direzione o di governo - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Published: Mar 19, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct Healthcare Professional Communication (DHPC) on Remsima (infliximab)

Remsima (infliximab): New IV formulation (100 mg and 350 mg concentrate for solution for infusion) contains sorbitol and is therefore contraindicated in patients with hereditary fructose intolerance.

Published: Mar 19, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiarimento AIFA su parere rimborsabilità farmaci Alzheimer

L’Agenzia a conclusione definitiva dell’iter del procedimento comunicherà pubblicamente l’esito delle procedure.

Published: Mar 18, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Mar 18, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Collegio di Conciliazione - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Collegio di Conciliazione".

Published: Mar 17, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro PREVYMIS HSCT

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 17.03.2026 è aggiornato il registro di PREVYMIS per una specifica indicazione terapeutica.

Published: Mar 17, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro LIBTAYO Carcinoma della cervice

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 17.03.2026 è aggiornato il registro di KEYTRUDA per una specifica indicazione terapeutica.

Published: Mar 17, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro KEYTRUDA Carcinoma della cervice

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 17.03.2026 è aggiornato il registro di KEYTRUDA per una specifica indicazione terapeutica.

Published: Mar 17, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura PT web XOLAIR

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 17.03.2026 terminerà il monitoraggio mediante PT web di XOLAIR per una specifica indicazione terapeutica.

Published: Mar 17, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Registro OFEV

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 17.03.2026 terminerà il monitoraggio del Registro di monitoraggio di OFEV per una specifica indicazione terapeutica.

Published: Mar 17, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Verifica dei dati trasmessi alla banca dati per la tracciabilità del farmaco relativi all’anno 2025

Si avvisano tutti i titolari AIC che  è consentito l'accesso completo alla Banca Dati Centrale del farmaco per la tracciabilità, al fine di verificare i dati relativi alle forniture a carico del Servizio Sanitario Nazionale, comprensive dell'indicazione del mittente e del destinatario.

Published: Mar 16, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Verifica dei dati trasmessi alla banca dati per la tracciabilità del farmaco e aggiornamento dei dati ai fini del procedimento di ripiano, per l'anno 2025

Published: Mar 16, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA updates the Transparency Lists

AIFA has published the updated Transparency Lists of generic medicines together with the related reference prices, updated at 16 March 2026.

Published: Mar 16, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro MULTIFARMACO PPP, per i farmaci sottoposti a programma di prevenzione della gravidanza

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che il Registro Multifarmaco PPP (Programma di Prevenzione della Gravidanza) è aggiornato con l’inserimento di medicinali generici della pomalidomide.

Published: Mar 16, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA strengthens its commitment to inclusion

The initiative aims to make communication accessibility a structural part of all the Agency's activities, continuously ensuring full participation and equal opportunities for all staff.

Published: Mar 16, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 13/03/2026.

Published: Mar 13, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Mar 13, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito dell'avviso per il conferimento di posti di funzione dirigenziale di livello non generale di direzione di strutture complesse (Ufficio Affari internazionali)

Con riferimento all’avviso di interpello per il conferimento del posto di funzione dirigenziale di livello non generale di direzione dell’Ufficio Affari internazionali, si informa che è in corso la procedura di conferimento del relativo incarico dirigenziale al dott. Enrico Costa, dirigente sanitario AOUI-VR, in comando presso l’Agenzia italiana del farmaco.

Published: Mar 13, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2026

Published: Mar 13, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 16-20 marzo 2026.

Published: Mar 13, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Comunicazione AIFA su Barbesaclone 100 mg

Nuove e importanti informazioni relative alla produzione e alla distribuzione del medicinale a denominazione generica Barbesaclone 100mg compresse rivestite - PROROGA SCADENZA.

Published: Mar 13, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Mar 11, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di posti di funzione dirigenziale di livello non generale di direzione di struttura non complessa – AREA accesso al farmaco e HTA

Si procede all’attivazione della procedura di interpello per il conferimento dell’incarico dirigenziale di direzione dell’Area accesso al farmaco e HTA.

Published: Mar 11, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Accesso civico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Accesso civico".

Published: Mar 10, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Mar 10, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento scheda Multifarmaco di monitoraggio semplificato intravitreali anti VEGF - EIYZEI

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 07.03.2026 è possibile selezionare, nella scheda multifarmaco di monitoraggio semplificato antiVEGF IVT, il medicinale EIYZEI (aflibercept) per quattro specifiche indicazioni terapeutiche.

Published: Mar 9, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registri OPDIVO

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 07/03/2026 sono aggiornati i Registri di OPDIVO dedicati al monitoraggio delle indicazioni terapeutiche come da "Determina Presidenziale n. 207/2026".

Published: Mar 9, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web Registro di monitoraggio KISQALI carcinoma mammario stadio iniziale

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 07/03/2026 è possibile utilizzare il medicinale KISQALI (ribociclib) mediante registro di monitoraggio per una specifica indicazione ammessa alla rimborsabilità.

Published: Mar 9, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web Registro di monitoraggio LYVDELZI

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 07/03/2026 è possibile utilizzare il medicinale LYVDELZI (seladelpar) mediante registro di monitoraggio per una specifica indicazione ammessa alla rimborsabilità.

Published: Mar 9, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Riclassificazione delle gliflozine: un'analisi tecnica (data check)

L’Agenzia Italiana del Farmaco fornisce i dettagli e le verifiche tecniche sulle analisi apparse su alcuni organi di stampa in merito all'andamento della spesa farmaceutica.

Published: Mar 9, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Pubblicato il Regolamento recante norme sull'organizzazione e sul funzionamento della CSE dell’AIFA

L'Agenzia Italiana del Farmaco pubblica il Regolamento recante norme sull'organizzazione e sul funzionamento della Commissione scientifica ed economica del farmaco.

Published: Mar 9, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornato il modulo "Relazione andamento studio"

Il CCNCE ha aggiornato il modulo "Relazione andamento studio".

Published: Mar 9, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Intelligenza Artificiale e salute: le agenzie regolatorie al centro della rivoluzione farmaceutica

Alle sfide poste dall’uso dell’Intelligenza Artificiale è dedicato il dossier AIFA “Intelligenza Artificiale e salute. Come l’IA sta rivoluzionando la ricerca farmaceutica, la medicina di precisione e il futuro della salute globale”.

Published: Mar 9, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Mar 6, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 06/03/2026.

Published: Mar 6, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento portale e‑Dossier in vista dell’entrata in vigore delle nuove Linee guida

A partire dal 1° aprile 2026, il portale e‑Dossier consentirà la sottomissione dei dossier secondo quanto previsto dalle Linee guida per la compilazione del dossier a supporto dell’Health Technology Assessment di un medicinale ai fini della rimborsabilità e del prezzo a carico del Servizio Sanitario Nazionale pubblicate il 24 dicembre 2025.

Published: Mar 6, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Programmazione della spesa farmaceutica: incontro AIFA-Regione Siciliana

Prosegue e si consolida il dialogo tra l'Agenzia Italiana del Farmaco e le Regioni.

Published: Mar 5, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Modulo di autocertificazione Strutture di Fase I

Il modulo è stato aggiornato nella parte relativa all’indirizzo pec cui inviare la documentazione per le autocertificazioni di Fase I.

Published: Mar 5, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Hemgenix® (etranacogene dezaparvovec). Disponibile il report tecnico scientifico

L’Agenzia Italiana del Farmaco rende disponibile un report tecnico-scientifico sul medicinale Hemgenix® (etranacogene dezaparvovec).

Published: Mar 4, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Mar 4, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Mar 4, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Self-certification and 7% contribution

Please note that all pharmaceutical companies must provide their self-certification to the Italian Medicines Agency (AIFA) no later than 30 April 2026.

Published: Mar 3, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento degli elenchi dei farmaci innovativi e degli agenti antinfettivi al 31/01/2026

Disponibili i report di valutazione per il riconoscimento dell’innovatività.

Published: Mar 2, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 27/02/2026.

Published: Feb 27, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA supports the Rare Disease Day 2026

AIFA headquarters will be illuminated with the colours symbolizing the initiative on February 28 - Rare Disease Day, in order to shine a spotlight on a reality that cannot remain invisible.

Published: Feb 27, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Sistema misurazione valutazione Performance - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Sistema misurazione valutazione Performance".

Published: Feb 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Feb 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il rinnovo di incarichi di fascia economica S2/S3, diversi dalla struttura complessa, ai dirigenti sanitari dell’AIFA

Published: Feb 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Duchenne e mieloma multiplo: il SSN rimborsa due terapie innovative

Via libera del CdA AIFA a 6 nuovi medicinali (4 per malattie rare) e a nuove indicazioni in oncologia.

Published: Feb 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

List of class A and H medicinal products at 30 September 2025

AIFA makes available, to healthcare professionals, a list of class A and H medicinal products dispensed by the National Health Service, sorted by active ingredient and trade name.

Published: Feb 24, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Feb 23, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

New guidelines on the definition and classification of OTC and SOP medicines

AIFA adopted new guidelines concerning the definition and classification of over-the-counter (OTC) medicinal products and other medicinal products not subject to medical prescription (SOP).

Published: Feb 23, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

From “one-size-fits-all” medicine to tailored treatments

AIFA publishes Position Paper on precision medicine and appropriate prescriptions.

Published: Feb 23, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 20/02/2026.

Published: Feb 20, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esiti runione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile gli esiti dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 9-13 febbraio 2026.

Published: Feb 20, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Registri KALYDECO

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 19.02.2026 terminerà il monitoraggio dei Registri di monitoraggio di KALYDECO (ivacaftor) per due specifiche indicazioni terapeutiche.

Published: Feb 19, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Registri KAFTRIO

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 19.02.2026 terminerà il monitoraggio dei Registri di monitoraggio di KAFTRIO (ivacaftor/tezacaftor/elexacaftor) per due specifiche indicazioni terapeutiche

Published: Feb 19, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Feb 19, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Nuova casella di posta elettronica per le comunicazioni tra AIFA e Regioni

È attiva da oggi una nuova casella di posta elettronica dedicata alle relazioni istituzionali tra l'Agenzia, le Regioni e le Province Autonome di Trento e Bolzano.

Published: Feb 18, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro DUPIXENT_PRURIGO NODULARE

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a seguito della decisione CSE nella seduta di novembre u.s., è stato aggiornato il Registro DUPIXENT per una specifica indicazione terapeutica.

Published: Feb 18, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Biosimilar medicines in Italy: AIFA reports updated

The Agency publishes the reports on the monitoring of biosimilar drugs in Italy, updated to September 2025.

Published: Feb 18, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Feb 18, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Organi di revisione amministrativa e contabile - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Organi di revisione amministrativa e contabile".

Published: Feb 17, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Registro di monitoraggio IMNOVID (pomalidomide) e inserimento nel Registro PPP

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 17.02.2026 termina il monitoraggio del Registro IMNOVID (Pomalidomide) per due specifiche indicazioni terapeutiche.

Published: Feb 17, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro WINREVAIR Ipertensione arteriosa polmonare

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 17/02/2026 è possibile utilizzare il medicinale WINREVAIR, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Feb 17, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento scheda Multifarmaco di monitoraggio semplificato intravitreali anti VEGF - RANIVISIO

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 17.02.2026 è possibile selezionare, nella scheda multifarmaco di monitoraggio semplificato antiVEGF IVT, il medicinale RANIVISIO (ranibizumab) per alcune indicazioni terapeutiche.

Published: Feb 17, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Textile Supplementary Series for patch tests

Following the activities undertaken by the AIFA Technical Table for the clinical use of haptens for patch tests, the SIDAPA Textile Supplementary Series used since 2016 was updated.

Published: Feb 17, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Feb 16, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA updates the Transparency Lists

AIFA has published the updated Transparency Lists of generic medicines together with the related reference prices, updated at 16 February 2026.

Published: Feb 16, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti dirigenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti dirigenti".

Published: Feb 16, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 13/02/2026.

Published: Feb 13, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Italian Medicines Agency's online services will be unavailable due to scheduled maintenance

Users are hereby informed that AIFA’s online services will be unavailable from 6:00 to 7.00 p.m on Monday, 16 February 2026 due to extraordinary maintenance work on the Agency’s IT systems.

Published: Feb 13, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 February 2026

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) - 9-12 February 2026.

Published: Feb 13, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi politici, di amministrazione, di direzione o di governo - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Published: Feb 13, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi politici, di amministrazione, di direzione o di governo - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Published: Feb 12, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Feb 12, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi politici, di amministrazione, di direzione o di governo - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Published: Feb 11, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

New Multi-Beneficiary Mode for Online Payments

As of 18 February 2026, companies required to pay fees to the Italian Medicines Agency (AIFA) under the Ministerial Decree of 6 December 2016 may use the new PagoPA Multi-Beneficiary online payment mode.

Published: Feb 11, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Feb 11, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di posti di funzione dirigenziale di livello non generale di direzione di strutture complesse (Ufficio affari internazionali)

Avviso per il conferimento di posti di funzione dirigenziale di livello non generale di direzione di strutture complesse (Ufficio affari internazionali).

Published: Feb 11, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Feb 10, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento della Nota esplicativa relativa alla procedura del “silenzio/assenso” in accordo con la nuova EC Classification Guideline sulle variazioni

Si comunica alle Aziende titolari delle Autorizzazioni all’immissione in commercio (AIC) che, è stata aggiornata la nota esplicativa riguardante l’applicazione della procedura di Silenzio/Assenso.

Published: Feb 10, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Protocollo d’intesa AIFA – NADO (Organizzazione nazionale antidoping)

L’Agenzia Italiana del Farmaco fornisce alla NADO le informazioni sui medicinali dopanti autorizzati in Italia estratte dalla propria banca dati per la realizzazione di una piattaforma dedicata agli atleti.

Published: Feb 9, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 06/02/2026.

Published: Feb 6, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA in blu per la Giornata nazionale contro il bullismo e il cyberbullismo del 7 febbraio

In occasione della Giornata nazionale contro il bullismo e il cyberbullismo, che si celebra il 7 febbraio, anche l’AIFA intende contribuire alla doverosa riflessione pubblica sul fenomeno, soffermandosi sull’importanza di una risposta sanitaria appropriata e consapevole ai segnali di disagio, soprattutto in età evolutiva.

Published: Feb 6, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 9-13 febbraio 2026.

Published: Feb 6, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Definitive cessation of marketing of Natpar (parathyroid hormone)

Natpar (parathyroid hormone) 25, 50, 75 and 100 micrograms/dose powder and solvent for solution for injection: end of supply due to marketing cessation (discontinuation).

Published: Feb 6, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Nuove modalità di trasmissione degli stampati (RCP/FI/ETI) - video tutorial e FAQ

Si rendono disponibili due video tutorial mostrati nel corso del webinar del 28 gennaio 2026 e un documento di domande e risposte nel quale sono state raccolte le domande formulate nel corso.

Published: Feb 5, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Registro BYLVAY

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 05.02.2026 terminerà il monitoraggio del Registro di monitoraggio di BYLVAY per una specifica indicazione terapeutica.

Published: Feb 5, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web Registro di monitoraggio DUPIXENT BPCO

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 05/02/2026 è possibile utilizzare il medicinale DUPIXENT (omaveloxolone) mediante registro di monitoraggio per una specifica indicazione ammessa alla rimborsabilità.

Published: Feb 5, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct communication with healthcare professionals on Arixtra (fondaparinux sodium)

Arixtra (fondaparinux sodium): serious quality defect related to the needle in pre-filled syringe.

Published: Feb 5, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti dirigenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti dirigenti".

Published: Feb 4, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Feb 4, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA sostiene la Giornata Mondiale contro il cancro

Si celebra oggi la Giornata Mondiale contro il Cancro (World Cancer Day), iniziativa internazionale che richiama l’attenzione e l’impegno della comunità globale nella lotta contro una delle patologie più diffuse e impattanti del nostro tempo.

Published: Feb 4, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Oncologici, medicinali per le malattie rare, anti-Alzheimer: ecco l’onda dei nuovi medicinali approvati dall’EMA

Fino ad oggi l’80% è poi diventato rimborsabile in Italia. Nisticò, Presidente AIFA: “La strategia è quella di garantire anche il governo della spesa autorizzando la rimborsabilità di quei farmaci che dimostrino di apportate un reale vantaggio terapeutico rispetto a quelli già disponibili gratuitamente per i pazienti”

Published: Feb 3, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro ELREFXIO_MIELOMA MULTIPLO

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che è disponibile un aggiornamento del registro di ELREFXIO per una specifica indicazione terapeutica.

Published: Feb 3, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti dirigenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti dirigenti".

Published: Feb 3, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

List of class A and H medicinal products at 31 August 2025

AIFA makes available, to healthcare professionals, a list of class A and H medicinal products dispensed by the National Health Service, sorted by active ingredient and trade name.

Published: Feb 3, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Sunset Clause - Warning di prossima decadenza del 3 febbraio 2026

La comunicazione costituisce un pre-avviso di decadenza e contiene un elenco di medicinali in potenziale decadenza per mancata commercializzazione.

Published: Feb 3, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

Published: Feb 3, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Proton Pump Inhibitors (PPIs): AIFA introduces Note ‘N01’

A new Note will regulate the conditions for prescribing Proton Pump Inhibitors (PPIs) covered by the National Health Service.

Published: Feb 3, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Feb 2, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi politici, di amministrazione, di direzione o di governo - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Published: Feb 2, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Feb 2, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Il CCNCE pubblica le FAQ aggiornate e nuovi moduli

Il Centro di coordinamento nazionale dei comitati etici (CCNCE) rende disponibili un documento di “FAQ” aggiornate e i seguenti moduli, a supporto dei Comitati Etici e non vincolanti: “Relazione andamento studio”, “Parere Comitato Etico (CE)”, “Lettera al Medico di Medicina Generale (MMG) o Pediatra di Libera Scelta (PLS)”.

Published: Feb 2, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito avviso conferimento di posti di funzione dirigenziale di livello non generale di direzione di strutture complesse (Uffici)

Si informa che sono in corso le  procedure di conferimento dei relativi incarichi dirigenziali.

Published: Feb 2, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web Registro di monitoraggio SKYCLARYS

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 31/01/2026 è possibile utilizzare il medicinale SKYCLARYS (omaveloxolone) mediante registro di monitoraggio per una specifica indicazione ammessa alla rimborsabilità.

Published: Feb 2, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Feb 2, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 30/01/2026.

Published: Jan 30, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento elenchi medicinali omeopatici al 31 dicembre 2025

Con riferimento ai medicinali omeopatici che ricadono nella disciplina della Legge 190/2014, e della Legge 160/2019, si rendono disponibili gli aggiornamenti degli elenchi dei medicinali omeopatici autorizzati alla commercializzazione sul territorio italiano.

Published: Jan 30, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esiti runione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile gli esiti dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 19-23 gennaio 2026.

Published: Jan 30, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Piano e Relazione sulla performance - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Piano e Relazione sulla performance".

Published: Jan 30, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Prevenzione della Corruzione - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Prevenzione della Corruzione".

Published: Jan 30, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Piano triennale per prevenzione della corruzione e della trasparenza - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Piano triennale per prevenzione della corruzione e della trasparenza".

Published: Jan 30, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Jan 30, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Neglected tropical diseases: defending global health

‘Unite, Act and Eliminate’. To join forces, take action and eliminate neglected tropical diseases: this is the call relaunched by the WHO on World Neglected Tropical Diseases Day 2026. AIFA wholeheartedly supports this appeal.

Published: Jan 30, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Monitoraggio AIFA spesa farmaceutica gennaio-settembre 2025

In totale la spesa farmaceutica (acquisiti diretti + convenzionata) nei primi 9 mesi dell’anno si attesta a 18 miliardi e 420 milioni, con uno scostamento dal tetto programmato pari a 2,85 miliardi di euro. 

Published: Jan 29, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Jan 29, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Amministrazione Trasparente - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Amministrazione Trasparente".

Published: Jan 29, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Prevenzione della Corruzione - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Prevenzione della Corruzione".

Published: Jan 29, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Jan 29, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Monitoring of Pharmaceutical expenditure - January / September 2025

AIFA has published the documents relating to the monthly monitoring of national and regional pharmaceutical expenditure for the periods January / September 2025.

Published: Jan 28, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro JEMPERLI PAZIENTE CANDIDABILE TERAPIA SISTEMICA

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 28/01/2026 è possibile utilizzare il medicinale JEMPERLY (Dostarlimab), in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Jan 28, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro HETRONIFLY

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 28/01/2026 è possibile utilizzare il medicinale HETRONIFLY (Serplulimab), in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Jan 28, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Cystic fibrosis: the number of patients eligible for free access to new CFTR modulator medicines has been expanded

The Board of Directors' approval covered two orphan drugs, two new molecules, seven generics, three biosimilars and five therapeutic indication extensions.

Published: Jan 28, 2026 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Jan 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il rinnovo di incarichi di fascia economica S2/S3, diversi dalla struttura complessa, ai dirigenti sanitari dell’AIFA

Published: Jan 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Italian Medicines Agency's online services will be unavailable due to scheduled maintenance

Users are hereby informed that AIFA’s online services will be unavailable from 6:00 p.m on Tuesday, 27 January 2026, to 8.00 a.m on Wesneday, 28 January 2026 due to extraordinary maintenance work on the Agency’s IT systems.

Published: Jan 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dati sui pagamenti - aggiornamento sezione- aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dati sui pagamenti".

Published: Jan 26, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 23/01/2026.

Published: Jan 23, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dati ulteriori - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dati ulteriori".

Published: Jan 23, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Jan 23, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Estrazione confezioni dispensate di farmaci innovativi e antibiotici reserve/listed - Anno 2025

Si informano gli utenti del Sistema dei Registri di monitoraggio AIFA che, in data 15/03/2026, verrà effettuata l’estrazione delle confezioni dispensate nell’anno 2025, relative ai farmaci innovativi e agli antibiotici reserve/listed.

Published: Jan 23, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento - Esito avviso per il conferimento di posti di funzione dirigenziale di livello non generale non corrispondenti a strutture complesse (Aree) - Dirigenti 2° fascia

Aggiornamento - esito avviso per il conferimento di posti di funzione dirigenziale di livello non generale non corrispondenti a strutture complesse (Aree) - Dirigenti 2° fascia.

Published: Jan 23, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento degli elenchi dei farmaci innovativi e degli agenti antinfettivi al 31/12/2025

Disponibili i report di valutazione per il riconoscimento dell’innovatività.

Published: Jan 23, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Nuovo Regolamento AIFA: riassegnate le competenze su Certificazione del Plasma Master File e import/export di sangue umano e suoi prodotti

Con la nuova organizzazione sono assegnate rispettivamente all’Ufficio Ispezioni e Autorizzazioni GMP materie prime e all’Ufficio Procedure Europee e Nazionali.

Published: Jan 23, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Nuovo indirizzo PEC per l'invio delle istanze di accreditamento, di revoca e di cessazione dei procuratori e delle elezioni di domicilio digitale presso l’AIFA

Si comunica che, a decorrere dal 1° febbraio 2026, tutti i soggetti interessati dovranno inviare le istanze di accreditamento, di revoca e di cessazione degli effetti delle procure e le elezioni di domicilio digitale presso l’AIFA esclusivamente all’indirizzo di posta elettronica certificata (PEC) protocollo@pec.aifa.gov.it.

Published: Jan 22, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro PADCEV

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 22.01.2026 è aggiornato il registro di PADCEV per una specifica indicazione terapeutica.

Published: Jan 22, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Il 28 gennaio webinar per le aziende sulle nuove modalità di trasmissione degli stampati (RCP/FI/ETI)

Mercoledì 28 gennaio alle ore 11:00. Necessario registrarsi tramite link.

Published: Jan 22, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Jan 22, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Jan 22, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Indicatore di tempestività dei pagamenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Indicatore di tempestività dei pagamenti".

Published: Jan 22, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento - Registro PEMBROLIZUMAB-LENVATINIB secondo Legge 648/96

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a seguito della decisione CSE nella seduta di giugno u.s. è stato aggiornato il Registro di Pembrolizumab lenvatinib dedicato al monitoraggio di una specifica indicazione terapeutica.

Published: Jan 21, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro PADCEV KEYTRUDA Carcinoma Uroteliale

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 21.01.2026 è possibile utilizzare il medicinale PADCEV in associazione a pembrolizumab, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Jan 21, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro KEYTRUDA PADCEV Carcinoma Uroteliale

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 21.01.2026 è possibile utilizzare il medicinale KEYTRUDA in associazione a enfortumab vedotin, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Jan 21, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro KEYTRUDA CARBOPLATINO PACLITAXEL Carcinoma endometriale

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 21.01.2026 è possibile utilizzare il medicinale KEYTRUDA (pembrolizumab), in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Jan 21, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registri KEYTRUDA

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 21.01.2026 sono aggiornati i Registri di KEYTRUDA dedicati al monitoraggio delle indicazioni terapeutiche come da determina allegata.

Published: Jan 21, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Jan 21, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Jan 20, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Indicatore di tempestività dei pagamenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Indicatore di tempestività dei pagamenti".

Published: Jan 20, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 16/01/2026.

Published: Jan 16, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 19-23 gennaio 2026.

Published: Jan 16, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro BRAFTOVI - MEKTOVI

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, è stato aggiornato il Registro di Monitoraggio di MEKTOVI in associazione a BRAFTOVI dedicato al monitoraggio di una specifica indicazione terapeutica.

Published: Jan 16, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Atti degli Organismi indipendenti di valutazione - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Atti degli Organismi indipendenti di valutazione".

Published: Jan 15, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA updates the Transparency Lists

AIFA has published the updated Transparency Lists of generic medicines together with the related reference prices, updated at 15 January 2025.

Published: Jan 15, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Nuove funzionalità del sistema Autorizzazione Convegni e Congressi

A partire dal lunedì 19/01/2026 alle ore 13:00, sarà disponibile una nuova funzionalità all’interno del Sistema Autorizzazione Convegni e Congressi, che prevede l’introduzione di un campo facoltativo denominato “Date intermedie”.

Published: Jan 14, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Informativa su potenziali carenze di farmaci per ustioni

L'Agenzia Italiana del Farmaco, in relazione alla vicenda dei ragazzi ustionati in seguito all'incendio di Crans-Montana del 31 dicembre 2025, ha verificato le segnalazioni di carenza di un prodotto utilizzato per lo sbrigliamento enzimatico della escara dell'ustione.

Published: Jan 13, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Jan 13, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Jan 13, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di posti di funzione dirigenziale di livello non generale di direzione di strutture complesse (Uffici)

Published: Jan 13, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web Registro di monitoraggio PIASKY

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 11/01/2026 è possibile utilizzare il medicinale PIASKY mediante registro di monitoraggio per una specifica indicazione ammessa alla rimborsabilità.

Published: Jan 12, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro MULTIFARMACO PPP, per i farmaci sottoposti a programma di prevenzione della gravidanza

Published: Jan 9, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 09/01/2026.

Published: Jan 9, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi di collaborazione o consulenza - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi di collaborazione o consulenza".

Published: Jan 8, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Applicazione della riduzione del 5% - aggiornamento dei prezzi al pubblico

Si comunica che la Direzione Tecnico-Scientifico dell'Agenzia ha adottato la Determinazione n. 1/2026, concernente l’aggiornamento dei prezzi dei medicinali di cui all’Allegato 2 della Determinazione n. 80/2025.

Published: Jan 7, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Atti di concessione - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Atti di concessione".

Published: Jan 7, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Jan 7, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

List of class A and H medicinal products at 31 July 2025

AIFA makes available, to healthcare professionals, a list of class A and H medicinal products dispensed by the National Health Service, sorted by active ingredient and trade name.

Published: Jan 7, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 02/01/2026.

Published: Jan 2, 2026 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Legge di Bilancio 2026: abolita la facoltà di sospendere la riduzione di legge del 5%

Legge di Bilancio 2026: abolita la facoltà di sospendere la riduzione di legge del 5%.

Published: Dec 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dati relativi ai premi - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dati relativi ai premi".

Published: Dec 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Dec 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito avviso conferimento di posti di funzione dirigenziale di livello non generale - Direzione degli Uffici a strutture complesse

Con riferimento all’avviso di interpello per il conferimento dei posti di funzione dirigenziale di livello non generale di direzione degli Uffici corrispondenti a strutture complesse individuati dal Regolamento di funzionamento e ordinamento del personale dell’AIFA, adottato con Delibera del Consiglio di amministrazione del 17 settembre 2025, n. 52, e indicati nel prospetto di cui all’Allegato 1 dell’avviso del 17 dicembre 2025, n. 161398, si informa che sono in corso le procedure di conferimento dei relativi incarichi dirigenziali, con decorrenza 1° gennaio 2026.

Published: Dec 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Modalità compilazione scheda di dispensazione registri di monitoraggio antibiotici reserve e listed

Si informano gli utenti dei Registri di Monitoraggio che, si rende necessario comunicare le modalità per la corretta rendicontazione delle confezioni e/o delle eventuali singole unità posologiche partizionate dei farmaci antibiotici Recarbrio, Sivextro, Vaborem, Xerava, Zavicefta, Zerbaxa, Emblaveo, Exblifep.

Published: Dec 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 24/12/2025.

Published: Dec 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento degli elenchi dei farmaci innovativi e degli agenti antinfettivi al 30/11/2025

Disponibili i report di valutazione per il riconoscimento dell’innovatività.

Published: Dec 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Guidelines for compiling the dossier of a medicinal product for pricing and reimbursement borne by the NHS

AIFA informs that pursuant to Resolution of the Technical-Scientific Director No. 88/2025 of 23/12/2025, the ‘Guidelines for compiling the dossier supporting the Health Technology Assessment of a medicinal product for the purposes of pricing and reimbursement borne by the National Health Service’ have been updated.

Published: Dec 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Il CCNCE pubblica la Relazione sui CET/CEN

Il Centro di coordinamento nazionale dei comitati etici (CCNCE) rende disponibile la “Relazione sui 40 Comitati Etici Territoriali (CET) e sui 3 Comitati Etici Nazionali (CEN): esiti della survey e delle interviste ai CET/CEN".

Published: Dec 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Manutenzione Straordinaria dei Servizi Online AIFA: Comunicazione agli Utenti

Users of AIFA’s online services are hereby informed that, due to extraordinary maintenance activities, from 12:00 p.m. on 2 January 2026 until 3:00 p.m. on 5 January 2026, the following applications will be unavailable.

Published: Dec 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito dellla procedura per il conferimento dell’incarico dirigenziale di direzione dell’Ufficio Stampa e comunicazione

Si fa riferimento all’avviso di interpello per il conferimento dei posti di funzione dirigenziale di livello non generale di direzione di direzione degli Uffici non corrispondenti a strutture complesse individuate dal Regolamento di funzionamento e ordinamento del personale dell’AIFA, in particolare, al conferimento dell’incarico dirigenziale di direzione dell’Ufficio Stampa e comunicazione.

Published: Dec 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Biosimilar medicines in Italy: AIFA reports updated

The Agency publishes the reports on the monitoring of biosimilar drugs in Italy, updated to June 2025.

Published: Dec 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Sarà rimborsato dal SSN il primo trattamento (Skyclarys) per l’Atassia di Friedreich

Ammessi alla rimborsabilità dal CdA dell'AIFA 7 farmaci (di cui 3 orfani), 2 generici e 6 estensioni di indicazione terapeutica.

Published: Dec 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 19/12/2025.

Published: Dec 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti dirigenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti dirigenti".

Published: Dec 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Disponibile “OsMed interattivo”, aggiornato con i dataset più recenti su consumi e spesa dei farmaci in Italia

AIFA rende disponibile online “OsMed interattivo”, la piattaforma che consente l’accesso strutturato alle elaborazioni dell’ultima edizione del Rapporto OsMed (2023-2024, aggiornato al 26 aprile 2025) e permette di effettuare interrogazioni personalizzate su indicatori di utilizzo e spesa, a livello nazionale e regionale, mediante tabelle dinamiche, grafici interattivi e strumenti di confronto multilivello.

Published: Dec 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct Healthcare Professional Communication (DHPC) on Carbamazepine (Tegretol 100 mg/5ml Oral Suspension)

Direct Healthcare Professional Communication (DHPC) - Carbamazepine (Tegretol 100 mg/5ml Oral Suspension): restriction of use in neonates as concentration of the excipient, propylene glycol, exceeds recommended threshold.

Published: Dec 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Carenze di medicinali: aggiornamenti sugli obblighi di comunicazione dei titolari AIC, come modificati dalla "Legge semplificazioni"

Published: Dec 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti dirigenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti dirigenti".

Published: Dec 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Dec 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Nuove modalità di trasmissione del Riassunto delle Caratteristiche del Prodotto (RCP), del Foglio Illustrativo (FI) e delle Etichette (ETI)

Tutte le Aziende Titolari che già accedono al Portale Variazioni, a partire dal giorno 1 febbraio 2026, saranno automaticamente abilitate ad accedere, tramite il portale Servizi On-line, alla nuova BDS.

Published: Dec 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Dec 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

IncreaseNET: è online il primo articolo di ricerca prodotto nell'ambito del progetto

Pubblicato su Clinical Pharmacology & Therapeutics (ASCPT).

Published: Dec 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dotazione organica - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dotazione organica".

Published: Dec 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dotazione organica - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dotazione organica".

Published: Dec 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Dec 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di posti di funzione dirigenziale di livello non generale - Direzione degli Uffici a strutture complesse

Published: Dec 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Dec 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Dec 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito avviso conferimento di posti di funzione dirigenziale di livello non generale di direzione degli Uffici corrispondenti a strutture complesse

Published: Dec 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Important information on supply shortage of Insulin Lispro Sanofi

Cheplapharm Arzneimittel GmbH has informed AIFA and EMA that the shortage of Visudyne (verteporfin) is expected to continue in all EU/EEA countries until the end of 2026.

Published: Dec 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Monitoring of Pharmaceutical expenditure - January / June 2025

AIFA has published the documents relating to the monthly monitoring of national and regional pharmaceutical expenditure for the periods January / June 2025.

Published: Dec 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avvio del procedimento di Pay-Back convenzionata 1,83% e della procedura di retrocessione - 1° semestre 2025

Si informano le aziende farmaceutiche che dal 16 dicembre 2025 sarà attivo il servizio online “Spending-Pha” per la gestione del procedimento di payback 1,83% I semestre 2025.

Published: Dec 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito per il conferimento di posti di funzione dirigenziale di livello non generale di direzione degli Uffici non corrispondenti a strutture complesse (cd. posti grigi)

Con riferimento all’avviso di interpello per il conferimento dei posti di funzione dirigenziale di livello non generale di direzione di direzione degli Uffici non corrispondenti a strutture complesse individuate dal Regolamento di funzionamento e ordinamento del personale dell’AIFA, si informa che sono in corso le procedure di conferimento dei relativi incarichi dirigenziali.

Published: Dec 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dismissione casella di posta elettronica certificata (PEC) - Ufficio Procedure Centralizzate

A partire dal 1° gennaio 2026 le comunicazioni all’Ufficio Procedure Centralizzate dovranno essere inviate all’indirizzo protocollo@pec.aifa.gov.it.

Published: Dec 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro BREYANZI II linea

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 16/12/2025 è possibile utilizzare il medicinale BREYANZI, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Dec 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Mobilità volontaria per n. 8 unità di personale appartenenti all’Area dei Funzionari - Esito selezione

Mobilità volontaria per n. 8 unità di personale appartenenti all’Area dei Funzionari - Esito selezione.

Published: Dec 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Mobilità volontaria per n. 5 unità di personale appartenenti all’Area degli Assistenti - Esito selezione

Mobilità volontaria per n. 5 unità di personale appartenenti all’Area degli Assistenti - Esito selezione.

Published: Dec 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Dec 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dati ulteriori - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dati ulteriori ".

Published: Dec 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA updates the Transparency Lists

AIFA has published the updated Transparency Lists of generic medicines together with the related reference prices, updated at 15 December 2025.

Published: Dec 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Farmaci per il trattamento del diabete mellito tipo 2: nuove posologie del principio attivo semaglutide

Si tratta di una nuova formulazione di Rybelsus, bioequivalente alla precedente ma con maggiore biodisponibilità, che andrà a sostituire la precedente formulazione.

Published: Dec 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 12/12/2025.

Published: Dec 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esiti runione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile gli esiti dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 1-5 dicembre 2025.

Published: Dec 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct Healthcare Professional Communication (DHPC) on tranexamic acid intravenous formulations

Tranexamic acid intravenous formulations - Serious including fatal adverse reactions due to inadvertent intrathecal administration.

Published: Dec 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento sull'utilizzo dei sistemi computerizzati nelle sperimentazioni cliniche alla luce della linea guida delle ICH E6 (R3)

AIFA fornisce un aggiornamento sull’utilizzo dei sistemi computerizzati nelle sperimentazioni cliniche, alla luce dell’entrata in vigore, il 23 luglio 2025, della versione R3 della linea guida ICH E6, Guideline for Good Clinical Practice (GCP R3).

Published: Dec 10, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA in Milan: a new era of collaboration between the Agency and the Regions

A meeting of the Board of Directors and the conference ‘Pharmaceuticals: the challenges of legislative innovation, research, and sustainability,’ organised in collaboration with the Lombardy Region.

Published: Dec 10, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Promoting public research, AIFA invites stakeholders to propose research areas on medicines

AIFA, the first medicines agency in Europe including among its institutional objectives the promotion of scientific research, publishes a survey in order to receive proposals on research needs in the pharmacological field, available until January 30, 2026.

Published: Dec 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito avviso per il conferimento di posti di funzione dirigenziale di livello non generale di direzione degli uffici non corrispondenti a strutture complesse

Con riferimento all’avviso di interpello per il conferimento dei posti di funzione dirigenziale di livello non generale di direzione di direzione degli Uffici non corrispondenti a strutture complesse, si informa che sono in corso le procedure di conferimento dei relativi incarichi dirigenziali.

Published: Dec 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 05/12/2025.

Published: Dec 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Mobilità volontaria per n. 5 unità di personale appartenenti all’ Area degli Assistenti - Criteri di valutazione

Mobilità volontaria per n. 5 unità di personale appartenenti all’ Area degli Assistenti - Criteri di valutazione.

Published: Dec 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Mobilità volontaria per n. 8 unità di personale appartenenti all’ Area dei Funzionari - Criteri di valutazione

Mobilità volontaria per n. 8 unità di personale appartenenti all’ Area dei Funzionari - Criteri di valutazione.

Published: Dec 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti dirigenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti dirigenti".

Published: Dec 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione nuove funzionalità RSO per adeguamento alla Linea Guida per la classificazione e conduzione degli studi osservazionali sui farmaci

Dal 4 dicembre 2025 sono attive nel Registro degli Studi Osservazionali (RSO), le nuove funzionalità implementate al fine di allineare i flussi operativi del sistema con la nuova Linea Guida per la classificazione e conduzione degli studi osservazionali sui farmaci.

Published: Dec 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA and the Public Prosecutor's Office of Velletri sign a memorandum of understanding to combat gender-based violence

A training and awareness-raising conference for staff held at the Agency's headquarters.

Published: Dec 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Implementazione PT web VYDURA acuto

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, è stato implementato il PT web di VYDURA per una specifica indicazione terapeutica.

Published: Dec 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Procedura semplificata per ulteriori tipologie di variazioni all’AIC di medicinali autorizzati con procedura nazionale o di mutuo riconoscimento/decentrata

Si comunica a tutte le Aziende Titolari di AIC che la (CSE) nella seduta del  10, 11, 12, 13 e 14 Novembre 2025 (Verbale CSE n. 29), ha approvato la proposta di semplificazione per la gestione di ulteriori tipologie di variazioni relative a medicinali autorizzati con procedura nazionale  o di mutuo riconoscimento/decentrata che, fino ad oggi, prevedevano il passaggio obbligato alla CSE.

Published: Dec 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Dec 2, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti dirigenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti dirigenti".

Published: Dec 2, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Antibiotici: “Se non sei un medico, non fare il medico”. Al via la Campagna promossa da AIFA in collaborazione con il Ministero della Salute

Spot sulle reti Rai e Mediaset, diffusione su stampa, emittenti locali e canali social.

Published: Dec 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Verso un modello fast-track per l'autorizzazione di studi clinici multinazionali nell'UE/SEE

L’impegno congiunto delle agenzie regolatorie europee e dei Comitati Etici.

Published: Nov 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 1-5 dicembre 2025.

Published: Nov 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA 2025 call for proposals for independent research on precision medicine and combating antibiotic resistance: over 100 projects submitted

Specifically, 32 study proposals concern the fight against superbugs and 75 concern precision medicine. 

Published: Nov 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 28/11/2025.

Published: Nov 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti dirigenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti dirigenti".

Published: Nov 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

“Procedura pay-back 5% - Anno 2025” - Determina AIFA n. 80/2025 del 24 novembre 2025

Si comunica che è stata pubblicata sulla Gazzetta Ufficiale della Repubblica Italiana n.  277 del 28 novembre 2025, la Determina AIFA n. 80/2025 del 24 novembre 2025, concernente la “Procedura pay-back 5% - Anno 2025”.

Published: Nov 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Italian Medicines Agency's online services will be unavailable due to scheduled maintenance

Users are hereby informed that AIFA’s online services will be unavailable from 16:00 to 19:00 on Tuesday, 2 December 2025, due to extraordinary maintenance work on the Agency’s IT systems.

Published: Nov 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct Healthcare Professional Communication (DHPC) on Rybelsus (oral semaglutide)

Rybelsus (oral semaglutide): risk of medication error due to introduction of new formulation with increased bioavailability.

Published: Nov 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Nov 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Biosimilar medicines in Italy: AIFA reports updated

The Agency publishes the reports on the monitoring of biosimilar drugs in Italy, updated to May 2025.

Published: Nov 25, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Payback convenzionata 1,83%: Procedura di revisione dell’anagrafica dei medicinali movimentati nel corso del I semestre 2025

Si informano le aziende farmaceutiche che, dal 25 novembre 2025, sarà attivo il servizio online “Spending-Pha” per la procedura di revisione dell’anagrafica dei medicinali oggetto del procedimento e che è possibile presentare eventuali richieste di rettifica entro e non oltre il 1° dicembre 2025.

Published: Nov 25, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Hepatitis C: update of 27 November 2025 concerning enrolled patients

AIFA has published the updated weekly data concerning treatments with new second-generation direct acting antiviral agents (DAAs) for chronic hepatitis C, as collected by AIFA Monitoring registries.

Published: Nov 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro di monitoraggio VYVGART_MGg

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 22/11/2025, è possibile utilizzare la nuova confezione di Vyvgart per una nuova indicazione ammessa alla rimborsabilità.

Published: Nov 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento scheda Multifarmaco di monitoraggio semplificato intravitreali anti VEGF – MYNZEPLI

Si informano gli utenti dei Registri di Monitoraggio che, a partire dal 22/11/2025, è possibile selezionare, nella scheda multifarmaco di monitoraggio semplificato anti-VEGF IVT, il medicinale MYNZEPLI per specifiche indicazioni terapeutiche.

Published: Nov 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento scheda Multifarmaco di monitoraggio semplificato intravitreali anti VEGF – AFQLIR

Published: Nov 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento PT web based REBLOZYL_MDS

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 22/11/2025, è possibile utilizzare il medicinale REBLOZYL mediante Piano terapeutico Web based per una nuova indicazione ammessa alla rimborsabilità.

Published: Nov 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro di monitoraggio ROZLYTREK_NTRK

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 22/11/2025, è possibile utilizzare il medicinale ROZLYTREK mediante registro di monitoraggio per una indicazione ammessa alla rimborsabilità.

Published: Nov 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web Registro di monitoraggio BEYONTTRA_ATTR-CM

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 22/11/2025, è possibile utilizzare il medicinale BEYONTTRA mediante registro di monitoraggio per una indicazione ammessa alla rimborsabilità.

Published: Nov 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento degli elenchi dei farmaci innovativi e degli agenti antinfettivi al 31/10/2025

Disponibili i report di valutazione per il riconoscimento dell’innovatività.

Published: Nov 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 21/11/2025.

Published: Nov 21, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro ASPAVELI

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, è aggiornato il registro di ASPAVELI per una specifica indicazione terapeutica.

Published: Nov 21, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esiti runione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile gli esiti dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 10-14 novembre 2025.

Published: Nov 21, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA Ascolta: for an Agency closer to patients’ needs

Rules defined for transparent dialogue with associations. The AIFA Incontra project has also been redesigned for other stakeholders.

Published: Nov 21, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Board of Directors of 19 November 2025: medicines approved for reimbursement

Green light for a generic antiviral and two new indications of a monoclonal antibody.

Published: Nov 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Nov 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di posti di funzione dirigenziale di livello non generale di direzione degli Uffici corrispondenti a strutture complesse

Avviso per il conferimento di posti di funzione dirigenziale di livello non generale di direzione degli Uffici corrispondenti a strutture complesse.

Published: Nov 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di posti di funzione dirigenziale di livello non generale di direzione degli Uffici non corrispondenti a strutture complesse (cd. posti grigi)

Avviso per il conferimento di posti di funzione dirigenziale di livello non generale di direzione degli Uffici non corrispondenti a strutture complesse

Published: Nov 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito avviso per il conferimento di posti di funzione dirigenziale di livello non generale corrispondenti a strutture complesse (Aree) - Dirigenti sanitari

Published: Nov 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ripiano della spesa farmaceutica per acquisti diretti per l’anno 2024

L’Agenzia Italiana del Farmaco (AIFA), all’esito del contradditorio con le aziende farmaceutiche svolto nei mesi precedenti, ha adottato la determinazione n. 1655 concernente l’attribuzione delle singole quote di ripiano della spesa farmaceutica per acquisti diretti per l’anno 2024.

Published: Nov 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti dirigenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti dirigenti".

Published: Nov 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Nov 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

List of class A and H medicinal products at 31 June 2025

AIFA makes available, to healthcare professionals, a list of class A and H medicinal products dispensed by the National Health Service, sorted by active ingredient and trade name.

Published: Nov 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Accesso civico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Accesso civico".

Published: Nov 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Nov 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Mobilità volontaria per n. 8 unità di personale appartenenti all’ Area dei Funzionari - Nomina Commissione

Published: Nov 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Mobilità volontaria per n. 5 unità di personale appartenenti all’ Area degli Assistenti - Nomina Commissione

Published: Nov 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Today is European Antibiotic Awareness Day: European and national data, AIFA’s commitment

Stronger and faster action is needed to tackle the global phenomenon of antimicrobial resistance.

Published: Nov 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

AIFA updates the Transparency Lists

AIFA has published the updated Transparency Lists of generic medicines together with the related reference prices, updated at 17 November 2025.

Published: Nov 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Applicazione della nuova “Classification Guideline” relativa alle Variazioni all’AIC

La nuova Linea Guida sarà applicabile dal 15 gennaio 2026.

Published: Nov 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Nov 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 14/11/2025.

Published: Nov 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Revisione delle Note AIFA: abrogate le Note 8, 92 e 101

Per tutti i provvedimenti di abrogazione delle Note, l’Agenzia effettuerà un monitoraggio della spesa e dei consumi dei medicinali interessati, a 6 e a 12 mesi dall’entrata in vigore delle nuove disposizioni.

Published: Nov 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Nov 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di posti di funzione dirigenziale di livello non generale di direzione degli uffici non corrispondenti a strutture complesse

Published: Nov 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito avviso per il conferimento di posti di funzione dirigenziale di livello non generale non corrispondenti a strutture complesse (Aree) - Dirigenti 2° fascia

Esito avviso per il conferimento di posti di funzione dirigenziale di livello non generale non corrispondenti a strutture complesse (Aree) - Dirigenti 2° fascia.

Published: Nov 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Nov 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi politici, di amministrazione, di direzione o di governo - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Published: Nov 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dati sui pagamenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dati sui pagamenti".

Published: Nov 10, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct communication with healthcare professionals on Libtayo (cemiplimab)

Libtayo (cemiplimab) 350 mg concentrate for solution for infusion: Batch / lot number and expiry date may become illegible following sanitisation and wiping of vial label.

Published: Nov 10, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

National Report on Medicines Use in Italy (OsMed) - year 2024

Stable consumption: almost 2 doses per person per day in 2024. Overall pharmaceutical expenditure has increased (+2.8%), driven by increased public expenditure (+7.7%) in the face of an increasing number of innovative and high-cost therapies reimbursed by the NHS.

Published: Nov 10, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Ordine del giorno riunione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 10-14 novembre 2025.

Published: Nov 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 07/11/2025.

Published: Nov 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Contrattazione integrativa - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Contrattazione integrativa".

Published: Nov 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web ed aggiornamento Registri di monitoraggio SARCLISA MM1L

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 07/10/2025 è possibile utilizzare il medicinale SARCLISA mediante registro di monitoraggio per una specifica indicazione ammessa alla rimborsabilità.

Published: Nov 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registri KAFTRIO KALYDECO

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 06.11.2025 sono aggiornati i registri di KAFTRIO/KALYDECO per due specifiche indicazioni terapeutiche.

Published: Nov 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Comunicazione AIFA su Barbesaclone 25 mg

Nuove e importanti informazioni relative alla produzione e alla distribuzione del medicinale a denominazione generica Barbesaclone 25 mg compresse rivestite - PROROGA SCADENZA.

Published: Nov 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Istruzioni sulla gestione telematica degli atti e dei documenti dell’ufficio ispezioni GCP

A partire dal 1° dicembre 2025, cambiano le modalità per la presentazione di atti e documenti relativi all'attività ispettiva GCP.

Published: Nov 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Nuovo servizio online GMPMED per il riconoscimento dell’idoneità ad esercitare la funzione di Persona qualificata

L’Ufficio Ispezioni ed Autorizzazioni GMP Medicinali (Ufficio GMPMED) rende noto che, a decorrere dal 1° dicembre 2025, sarà operativo il nuovo servizio online Persone Qualificate.

Published: Nov 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Nov 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esiti runione straordinaria Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile gli esiti dei lavori della riunione straordinaria della Commissione Scientifica e Economica (CSE) del 30 ottobre 2025.

Published: Nov 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Kaftrio, AIFA committed to quickly concluding the assessment of reimbursement for new indications

The Italian Medicines Agency, aware of the importance of treating a serious and complex disease such as cystic fibrosis, is working to ensure that patients have the best treatment options while respecting the sustainability of the National Health Service.

Published: Nov 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

List of class A and H medicinal products at 31 May 2025

AIFA makes available, to healthcare professionals, a list of class A and H medicinal products dispensed by the National Health Service, sorted by active ingredient and trade name.

Published: Nov 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro ZEJULA

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 01.11.2025 è aggiornato il registro di ZEJULA per una specifica indicazione terapeutica.

Published: Nov 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Save the date - Rapporto OsMed 2024 sull’uso dei Farmaci in Italia

Conferenza di presentazione. Saranno presenti il Presidente dell’Agenzia Robert Nisticò e il Direttore Tecnico-Scientifico Pierluigi Russo.

Published: Nov 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct Healthcare Professional Communication (DHPC) on Levetiracetam (Keppra and Levetiracetam UCB)

Levetiracetam (Keppra and Levetiracetam UCB) oral solution (150mL bottle for children aged 6 months to 4 years):  risk of medication error due to Change of dosing syringe.

Published: Nov 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA joins 10th anniversary campaign for safer use of medicines

Everyone has a role to play in medicines safety. By reporting suspected side effects, you and I can help make medicines safer for everyone,

Published: Nov 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 31/10/2025.

Published: Oct 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 October 2025

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) – 27-30 October 2025.

Published: Oct 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esiti runione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile gli esiti dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 20-21-22-23-24 ottobre 2025.

Published: Oct 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avvio procedimento e apertura piattaforma Pay-Back 5% - anno 2025

Si informano le aziende farmaceutiche che dalle ore 12:00 del 30 ottobre sarà attivo il servizio online “Spending-Pha” per la gestione del procedimento di payback 5% per l’anno 2025 e che è possibile presentare eventuali osservazioni entro e non oltre il 6 novembre p.v. ore 18:00.

Published: Oct 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Monitoring of Pharmaceutical expenditure - January / May 2025

AIFA has published the documents relating to the monthly monitoring of national and regional pharmaceutical expenditure for the periods January / May 2025.

Published: Oct 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione straordinaria Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione straordinaria della Commissione Scientifica e Economica (CSE) del 30 ottobre 2025.

Published: Oct 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct communication with healthcare professionals on Lenalidomide Mylan

Lenalidomide Mylan (lenalidomide): potential for damaged capsules and precautionary handling measures.

Published: Oct 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Board of Directors meeting of October 28, 2025, medicines eligible for reimbursement

Two new molecules, one extension of therapeutic indication, one parallel import medicine, one generic medicine, and seven biosimilars.

Published: Oct 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Hepatitis C: update of 27 October 2025 concerning enrolled patients

AIFA has published the updated weekly data concerning treatments with new second-generation direct acting antiviral agents (DAAs) for chronic hepatitis C, as collected by AIFA Monitoring registries.

Published: Oct 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Amministrazione Trasparente - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Amministrazione Trasparente".

Published: Oct 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Prevenzione della Corruzione - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Prevenzione della Corruzione".

Published: Oct 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Indicatore di tempestività dei pagamenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Indicatore di tempestività dei pagamenti".

Published: Oct 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro di monitoraggio VOXZOGO

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 28/10/2025 è possibile utilizzare il medicinale VOXZOGO mediante registro di monitoraggio per l’estensione di una indicazione ammessa alla rimborsabilità.

Published: Oct 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web Registro di monitoraggio TEPKINLY LF

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 28/10/2025 è possibile utilizzare il medicinale TEPKINLY mediante registro di monitoraggio per una indicazione ammessa alla rimborsabilità.

Published: Oct 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web Registro di monitoraggio CAMZYOS

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 28/10/2025 è possibile utilizzare il medicinale CAMZYOS mediante registro di monitoraggio per una indicazione ammessa alla rimborsabilità.

Published: Oct 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro LUMSUMIO

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 28.10.2025 è aggiornato il registro di LUMSUMIO per una specifica indicazione terapeutica.

Published: Oct 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Indicatore di tempestività dei pagamenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Indicatore di tempestività dei pagamenti".

Published: Oct 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso di mobilità volontaria per n. 8 unità di personale appartenenti all’ Area dei Funzionari

Avviso di mobilità volontaria per valutazione curriculare e colloquio, per l’immissione nei ruoli del personale dell’AIFA di n. 8 unità di personale appartenenti all’ Area dei Funzionari.

Published: Oct 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso di mobilità volontaria per n. 5 unità di personale appartenenti all’ Area degli Assistenti

Avviso di mobilità volontaria per valutazione curriculare e colloquio, per l’immissione nei ruoli del personale dell’Agenzia Italiana del Farmaco di n. 5 unità di personale appartenenti all’ Area degli Assistenti.

Published: Oct 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro ELREFXIO MIELOMA MULTIPLO

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che è disponibile un aggiornamento del registro di ELREFXIO per una specifica indicazione terapeutica.

Published: Oct 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web Registro di monitoraggio VANFLYTA

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 25/10/2025 è possibile utilizzare il medicinale VANFLYTA mediante registro di monitoraggio per due indicazione ammesse alla rimborsabilità.

Published: Oct 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento degli elenchi dei farmaci innovativi e degli agenti antinfettivi al 30/09/2025

Disponibili i report di valutazione per il riconoscimento dell’innovatività.

Published: Oct 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 24/10/2025.

Published: Oct 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di posti di funzione dirigenziale di livello non generale corrispondenti a strutture complesse (Aree) - Dirigenti 2° fascia

I dirigenti di II fascia dell’AIFA, i dirigenti di altre amministrazioni in posizione giuridica equivalente e il rimanente personale interessato, potranno candidarsi per un massimo di due posizioni, senza ordine di priorità.

Published: Oct 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di posti di funzione dirigenziale di livello non generale corrispondenti a strutture complesse (Aree) - Dirigenti sanitari

I dirigenti appartenenti al ruolo dei dirigenti sanitari dell’AIFA, già inquadrati nella seconda fascia al 1° gennaio 2025 interessati, potranno candidarsi per un massimo di due posizioni, senza ordine di priorità.

Published: Oct 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Oct 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ruolo dirigenti e Atti generali - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Ruolo dirigenti e Atti generali".

Published: Oct 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Oct 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di posizioni dirigenziali sanitarie. Rinnovo n. 4 incarichi presso ISA-FV-UPC-OC

Nelle more della definizione del nuovo assetto organizzativo interno dell’Agenzia, si rende necessario procedere ai rinnovi di specifici incarichi dirigenziali sanitari.

Published: Oct 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

EMA confirms suspension of sickle cell disease medicine Oxbryta

Higher rate of death and disease complications in recent trials means benefit-risk balance no longer favourable.

Published: Oct 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Disability Manager - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Disability Manager".

Published: Oct 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web ed aggiornamento Registri di monitoraggio KRAZATI

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 22/10/2025 è possibile utilizzare il medicinale KRAZATI mediante registro di monitoraggio per una specifica indicazione ammessa alla rimborsabilità.

Published: Oct 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro LUMYKRAS

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 22.10.2025 è aggiornato il registro di LUMYKRAS per una specifica indicazione terapeutica.

Published: Oct 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro KEYTRUDA 1L ESGGC

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 22.10.2025 è aggiornato il registro di KEYTRUDA per una specifica indicazione terapeutica.

Published: Oct 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Oct 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Sunset Clause - Warning di prossima decadenza del 21 ottobre 2025

La comunicazione costituisce un pre-avviso di decadenza e contiene un elenco di medicinali in potenziale decadenza per mancata commercializzazione.

Published: Oct 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ruolo dirigenti e Atti generali - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Ruolo dirigenti e Atti generali".

Published: Oct 21, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Contrattazione integrativa - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Contrattazione integrativa".

Published: Oct 21, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Hepatitis C: update of 20 October 2025 concerning enrolled patients

AIFA has published the updated weekly data concerning treatments with new second-generation direct acting antiviral agents (DAAs) for chronic hepatitis C, as collected by AIFA Monitoring registries.

Published: Oct 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 17/10/2025.

Published: Oct 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 20-21-22-23-24 ottobre 2025.

Published: Oct 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Secondo Bando AIFA di Ricerca Indipendente 2025: scadenza il 18 novembre per la presentazione dei progetti

C’è tempo fino alle 12 del prossimo 18 novembre per partecipare al secondo Bando 2025 di Ricerca Indipendente, promosso dall’Agenzia Italiana del Farmaco, che rafforza l’impegno a sostegno di studi no profit in aree strategiche per il Servizio sanitario nazionale.

Published: Oct 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Contrattazione integrativa - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Contrattazione integrativa".

Published: Oct 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA updates the Transparency Lists

AIFA has published the updated Transparency Lists of generic medicines together with the related reference prices, updated at 15 October 2025.

Published: Oct 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

The AIFA Activity Report Is Now Online

The report presents key data and activities from 2024, with comparisons to the previous two years.

Published: Oct 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct Healthcare Professional Communication (DHPC) on Nifedicor

Nifedicor 20 mg/ml oral drops, solution (nifedipine): modification of the dropper that varies the amount of medicine dispensed.

Published: Oct 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avvio procedura di revisione dell’elenco dei medicinali nell’ambito del procedimento di Payback 5% per l’anno 2025

Si informano le aziende farmaceutiche che, dalle ore 17:00 del 14 ottobre p.v., sarà attivo il servizio online “Spending-Pha” per la procedura di revisione dell’elenco dei medicinali oggetto del procedimento di payback 5% per l’anno 2025.

Published: Oct 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 10/10/2025.

Published: Oct 10, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi politici, di amministrazione, di direzione o di governo - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Published: Oct 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Medicines approved for reimbursement by the AIFA Board of Directors. These include two new molecules, three generics, three biosimilars and an extension of therapeutic indication

Green light for the reimbursement of the first subcutaneous treatment for paroxysmal nocturnal haemoglobinuria and the first three biosimilars of denosumab, the monoclonal antibody indicated for osteoporosis and bone loss.

Published: Oct 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Attivazione web e pubblicazione Registri CASGEVY TDT e SCD

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 08/10/2025 è possibile utilizzare il medicinale CASGEVY, in regime di rimborsabilità SSN, mediante registro di monitoraggio per due specifiche indicazioni terapeutiche.

Published: Oct 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web ed aggiornamento Registri di monitoraggio ZYNYZ MCC

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 08/10/2025 è possibile utilizzare il medicinale ZYNYZ mediante registro di monitoraggio per una specifica indicazione ammessa alla rimborsabilità.

Published: Oct 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web ed aggiornamento Registri di monitoraggio VOYDEYA EPN

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 08/10/2025 è possibile utilizzare il medicinale VOYDEYA mediante registro di monitoraggio per una specifica indicazione ammessa alla rimborsabilità.

Published: Oct 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Modifica Registro KEYTRUDA NEOADIUVANTE ADIUVANTE (NSCLC)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, è stato aggiornato il Registro di Monitoraggio di Keytruda (pembrolizumab) dedicato al monitoraggio di una specifica indicazione terapeutica.

Published: Oct 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct Healthcare Professional Communication (DHPC) on Crysvita (burosumab)

Cases of increased serum calcium, including severe hypercalcemia and/or increased parathyroid hormone levels, have been reported in patients treated with burosumab (Crysvita) particularly in patients with tertiary hyperparathyroidism.

Published: Oct 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct Healthcare Professional Communication (DHPC) on Caspofungin

Caspofungin: Avoid use of polyacrylonitrile membranes (PAN) during continuous renal replacement therapy (CRTT).

Published: Oct 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti dirigenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti dirigenti".

Published: Oct 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso relativo all’attivazione di comandi obbligatori presso AIFA - Anno 2025. Aggiornamento del 08/10/2025

Si comunica che, in data odierna, è disposta la chiusura dei termini per l'inoltro delle candidature relative al collocamento in posizione di comando obbligatorio presso l'Agenzia".

Published: Oct 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Oct 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Approvato il nuovo regolamento sul funzionamento dell’Agenzia

L’AIFA si riorganizza e punta sull’HTA per garantire la sostenibilità economica del sistema.

Published: Oct 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Attivazione web e pubblicazione schede di monitoraggio - Registro EVKEEZA

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 04/10/2025 è aggiornato il Registro dedicato al monitoraggio del medicinale EVKEEZA, a base di evinacumab, per due specifiche indicazioni ammesse alla rimborsabilità.

Published: Oct 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Oct 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 03/10/2025.

Published: Oct 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Criteri di individuazione degli scaglioni per la negoziazione automatica dei generici e dei biosimilari – scadenze brevettuali 2026

Elenco dei valori di spesa media annua del Servizio Sanitario Nazionale rilevati nei tre anni precedenti per i principi attivi attualmente in classe di rimborsabilità che scadranno nel 2025.

Published: Oct 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Hepatitis C: update of 29 September 2025 concerning enrolled patients

AIFA has published the updated weekly data concerning treatments with new second-generation direct acting antiviral agents (DAAs) for chronic hepatitis C, as collected by AIFA Monitoring registries.

Published: Oct 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ruolo dirigenti e Atti generali - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Ruolo dirigenti e Atti generali".

Published: Oct 2, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Oct 2, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Il CCNCE pubblica la Relazione di attività 2024-2025

Il Centro di Coordinamento Nazionale dei Comitati Etici territoriali per le sperimentazioni cliniche sui medicinali per uso umano e sui dispositivi medici (CCNCE) ha pubblicato la Relazione di attività relativa al periodo ottobre 2024 - settembre 2025.

Published: Oct 2, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Nuovo sistema informatico Workflow Officine Materie Prime

L’Ufficio Ispezioni ed Autorizzazioni GMP Materie Prime (Ufficio GMPAPI) rende noto che, a decorrere dal 27 ottobre 2025, sarà operativo il nuovo sistema informatico Workflow Officine Materie Prime (WF).

Published: Oct 2, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registri KEYTRUDA - adenocarcinoma

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che a partire dal 01.10.2025 sono aggiornati i registri di KEYTRUDA per due specifiche  indicazioni terapeutiche.

Published: Oct 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Clarifications regarding safety features on medicinal product packaging

A summary document is available for the stakeholders to provide clarifications on the provisions concerning medicinal product packaging pursuant to Legislative Decree No. 10 of February 6, 2025.

Published: Oct 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito avviso per il conferimento del posto di funzione di funzione dirigenziale di livello non generale - Settore Affari Internazionali

Esito avviso per il conferimento del posto di funzione di funzione dirigenziale di livello non generale - Settore Relazioni Internazionali

Published: Oct 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito avviso per il conferimento del posto di funzione di funzione dirigenziale di livello non generale - Ufficio relazioni istituzionali internazionali

sito avviso per il conferimento del posto di funzione di funzione dirigenziale di livello non generale - Ufficio relazioni istituzionali internazionali.

Published: Oct 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notice of updating of the annex 1 of AIFA’s Director-General Decision DG 34/2024

Updating of AIFA’s Director-General Decision DG 442/2023 Annex 1 - Renewal of the provisional authorisation to use haptens for patch tests in the absence of commercially-available clinical alternatives.

Published: Oct 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Biosimilar medicines in Italy: AIFA reports updated

The Agency publishes the reports on the monitoring of biosimilar drugs in Italy, updated to April 2025.

Published: Sep 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

New Features of the Conference and Congress Authorisation System

We would like to inform all pharmaceutical companies, organisational secretariats and providers that, starting from 1 October 2025, at 1 p.m., several changes and new features will be operational within the “Conference and Congress Authorisation System”.

Published: Sep 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Sep 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Raccolta di manifestazioni di interesse, per la nomina del Responsabile dei processi di inserimento delle persone con disabilità dell’AIFA - ResPID

Interpello per la raccolta di manifestazioni di interesse, da parte del personale dirigenziale e non dirigenziale di ruolo, per la nomina del Responsabile dei processi di inserimento delle persone con disabilità dell’AIFA - ResPID.

Published: Sep 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 26/09/2025.

Published: Sep 26, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esiti runione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile gli esiti dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 15-16-17-18-19 settembre 2025.

Published: Sep 26, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Sep 25, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

List of class A and H medicinal products at 30 April 2025

AIFA makes available, to healthcare professionals, a list of class A and H medicinal products dispensed by the National Health Service, sorted by active ingredient and trade name.

Published: Sep 25, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Use of paracetamol during pregnancy: European recommendations confirmed

The Italian Medicines Agency (AIFA) reports that, in light of the latest scientific assessments carried out at European level, there is no new evidence requiring changes to the current recommendations.

Published: Sep 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Chiusura MANAGED ENTRY AGREEMENTS (MEA) - Registro CAPRELSA

Si informano gli utenti dei Registri farmaci sottoposti a monitoraggio che, a partire dal 23.09.2025, le procedure di applicazione degli accordi di condivisione del rischio, ovvero i Managed Entry Agreements (MEA), non sono più attive per il registro CAPRELSA per una specifica indicazione terapeutica.

Published: Sep 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Registro CAPRELSA

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 23.09.2025, terminerà il monitoraggio del Registro di CAPRELSA per una specifica indicazione terapeutica.

Published: Sep 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio EXBLIFEP - Registro semplificato

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 23/09/2025, è stato istituito il Registro di monitoraggio per il medicinale EXBLIFEP in una specifica indicazione terapeutica rimborsata a carico del Servizio sanitario nazionale.

Published: Sep 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 19/09/2025.

Published: Sep 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Prevenzione della Corruzione - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Prevenzione della Corruzione".

Published: Sep 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Atti amministrativi generali - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Atti amministrativi generali".

Published: Sep 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Piano e Relazione sulla performance - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Piano e Relazione sulla performance".

Published: Sep 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Piano triennale per prevenzione della corruzione e della trasparenza - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Piano triennale per prevenzione della corruzione e della trasparenza".

Published: Sep 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Sep 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Sep 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Regolamento di funzionamento e ordinamento del personale dell’Agenzia Italiana del Farmaco

L'AIFA ha definitivamente adottato il Regolamento di funzionamento e ordinamento del personale dell’Agenzia Italiana del Farmaco, con deliberazione del CDA n. 52 del 17 settembre 2025.

Published: Sep 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA monitoring of pharmaceutical expenditure January-April 2025

Spending on medicines purchased directly by the Regions slows down.

Published: Sep 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Nisticò, Presidente AIFA: “La legge delega sulla legislazione farmaceutica occasione per migliorare accesso ed equità delle cure”

Così il Presidente di AIFA, Robert Nisticò, commenta il varo da parte del Consiglio dei Ministri del disegno di legge che delega il Governo a varare entro il 31 dicembre 2026 i decreti legislativi chiamati a razionalizzare le disposizioni che regolano il settore.

Published: Sep 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Important information on supply shortage of Visudyne (verteporfin)

Cheplapharm Arzneimittel GmbH has notified AIFA and EMA that the shortage of Visudyne (verteporfin) will continue until the of 2026 in all EU/EEA countries.

Published: Sep 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per procedura di mobilità volontaria

Published: Sep 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

The NHS will reimburse the first gene editing therapy for β-thalassemia and sickle cell anaemia

The AIFA Board of Directors approves the reimbursement of 7 new medicinal products (including 2 orphans), 6 generic medicines and 6 extensions of therapeutic indications.

Published: Sep 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Contrattazione integrativa - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Contrattazione integrativa".

Published: Sep 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

List of class A and H medicinal products at 31 March 2025

AIFA makes available, to healthcare professionals, a list of class A and H medicinal products dispensed by the National Health Service, sorted by active ingredient and trade name.

Published: Sep 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di posizioni dirigenziali sanitarie

Nelle more della definizione del nuovo assetto organizzativo interno dell’Agenzia, si rende necessario procedere all’espletamento della procedura di interpello finalizzata al conferimento degli incarichi dirigenziali sanitari in scadenza nel mese di ottobre.

Published: Sep 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct Healthcare Professional Communication (DHPC) - Finasteride, dutasteride – New measures to minimise the risk of suicidal ideation

Finasteride, dutasteride – New measures to minimise the risk of suicidal ideation.

Published: Sep 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA aggiorna le Liste di Trasparenza

L'Agenzia Italiana del Farmaco rende disponibile l'aggiornamento delle liste di trasparenza dei farmaci equivalenti con i relativi prezzi di riferimento aggiornati al 15 settembre 2025.

Published: Sep 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Registri TAGRISSO

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che terminerà il monitoraggio dei Registri di monitoraggio di TAGRISSO in specifiche indicazioni terapeutiche.

Published: Sep 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura PT web based PROLIA

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che terminerà il monitoraggio del PT web based di PROLIA in una specifica indicazione terapeutica.

Published: Sep 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

“Medicines are not sweets”. A European campaign to promote the responsible use of over-the-counter medicines

Read the leaflet, follow the instructions, and use (over-the-counter) medicines responsibly. This is the core message shared of a European-wide awareness campaign launched by regulatory authorities to encourage the responsible use of over-the-counter (OTC) medicines.

Published: Sep 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Divieto di utilizzo lotti medicinali plasmaderivati della ditta Takeda SpA

L’Agenzia Italiana del Farmaco ha disposto, per motivi esclusivamente precauzionali, il divieto di utilizzo di alcuni lotti dei medicinali : “ALBUMINA BAXALTA 200 G/L, 50ML” AIC n. 037566054 e “KIOVIG*1 flacone EV 50 ml 100 mg/ml – 5g/50ml”, della ditta Takeda SpA.

Published: Sep 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 15-16-17-18-19 settembre 2025.

Published: Sep 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 12/09/2025.

Published: Sep 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Hepatitis C: update of 8 September 2025 concerning enrolled patients

AIFA has published the updated weekly data concerning treatments with new second-generation direct acting antiviral agents (DAAs) for chronic hepatitis C, as collected by AIFA Monitoring registries.

Published: Sep 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Sep 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Accesso civico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Accesso civico".

Published: Sep 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

European Project IncreaseNET: the market investigation for the provision of training courses on pharmaceutical innovation will close on 22 September

The IncreaseNET project, funded under the European program - Joint Action EU4Health 2021-2027, involves 29 partners, mainly National Competent Authorities in the pharmaceutical sector.

Published: Sep 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA launches the second Independent Research Call for year 2025

Focus on precision medicine and fight against antimicrobial resistance, with a EUR 20 million funding.

Published: Sep 10, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Vaccini antinfluenzali 2025/2026: verifica su confezionamento primario e assenza di lattice

L’AIFA pubblica le informazioni relative all’assenza di lattice/latex/gomma naturale nelle diverse componenti dei confezionamenti primari (siringhe pre-riempite, nebulizzatore, ecc.), dei vaccini antinfluenzali autorizzati in Italia per la stagione influenzale 2025-2026, dopo le necessarie verifiche con le Aziende titolari dell’Autorizzazione all’Immissione in Commercio (AIC).

Published: Sep 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Influenza: 11 vaccines authorised for the 2025-2026 season

As autumn approaches, the Italian Medicines Agency communicates the list of vaccines authorised for the 2025-2026 influenza campaign. 

Published: Sep 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

AggiornaInnovative medicines list: AIFA publishes August 2025 update

AIFA updates the list of medicines that, in the opinion of the Scientific and Economic Committee for Medicines (CSE), meet the requirement of full or conditional therapeutic innovativeness.

Published: Sep 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Domande & Risposte sul Servizio Online "IMS – Informatori Scientifici"

Il documento ha l'obiettivo di fornire chiarimenti sulla pubblicità dei medicinali presso gli operatori sanitari.

Published: Sep 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct Healthcare Professional Communication (DHPC) - Clozapine and risk of neutropenia and agranulocytosis: PRAC updates recommendations for blood count monitoring

The PRAC has updated recommendations for blood monitoring in patients treated with clozapine. This medicine, indicated for treatment-resistant schizophrenia and psychotic disorders in Parkinson's disease, may increase the risk of neutropenia (reduction in neutrophils) and agranulocytosis.

Published: Sep 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct communication with healthcare professionals on Victoza

Victoza® 6 mg/mL solution for injection in pre-filled pen (liraglutide): Risk of supply shortage due to marketing cessation (discontinuation)

Published: Sep 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 05/09/2025.

Published: Sep 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti dirigenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti dirigenti".

Published: Sep 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 September 2025

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 September 2025.

Published: Sep 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Tassi di assenza - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Tassi di assenza".

Published: Sep 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ruolo dirigenti e Atti generali - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Ruolo dirigenti e Atti generali".

Published: Sep 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Procedura di applicazione Managed Entry Agreement - HEMGENIX Emofilia B

Si informano gli utenti dei Registri di Monitoraggio AIFA che dal 04/09/2025 è attiva, sulla piattaforma dei Registri, la procedura telematica di applicazione dell’accordo di condivisione del rischio per il medicinale HEMGENIX per una specifica indicazione terapeutica.

Published: Sep 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro HEMGENIX Emofilia B

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 04/09/2025 è possibile utilizzare il medicinale HEMGENIX, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Sep 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Modifiche monitoraggio LEQVIO e passaggio a PIANO TERAPEUTICO WEB-BASED

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, in data odierna è stata aggiornata la modalità di monitoraggio attraverso la Piattaforma AIFA della specialità medicinale Leqvio per due specifiche indicazioni rimborsate.

Published: Sep 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio ZEPATIER (HCV) - REGISTRO SEMPLIFICATO

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 04/09/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale ZEPATIER per una specifica indicazione terapeutica.

Published: Sep 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - PT web based ENTRESTO pazienti pediatrici Insufficienza Cardiaca Cronica Sintomatica

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 04/09/2025 è possibile utilizzare il medicinale ENTRESTO, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Sep 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento scheda Multifarmaco di monitoraggio semplificato intravitreali anti VEGF - VABYSMO (RVO)

Si informano gli utenti dei Registri di Monitoraggio che, a partire dal 04/09/2025 è possibile selezionare, nella scheda multifarmaco di monitoraggio semplificato anti-VEGF IVT, il medicinale VABYSMO per una specifica indicazione.

Published: Sep 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Comunicazione AIFA su Barbesaclone 100 mg

Nuove e importanti informazioni relative alla produzione e alla distribuzione del medicinale a denominazione generica Barbesaclone 100mg compresse rivestite - PROROGA SCADENZA.

Published: Sep 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Sep 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento del posto di funzione dirigenziale di livello non generale - Ufficio relazioni istituzionali internazionali

Nelle more della definizione del nuovo assetto organizzativo dell’Agenzia di cui al D.M. dell’8 gennaio 2024, n. 3, la Direzione tecnico-scientifica ha chiesto l’attivazione di un interpello per il conferimento dell’incarico di direzione dell’Ufficio relazioni istituzionali internazionali.

Published: Sep 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Allerta sull'aumento di farmaci illegali venduti nell'UE come agonisti del recettore del GLP-1

AIFA ribadisce che l’assetto della filiera legale nazionale, produttiva e distributiva, rende di fatto quasi impossibile l’infiltrazione di prodotti falsificati, che trovano diffusione solo attraverso canali illegali come i siti web non autorizzati e le piattaforme. Acquistare questi prodotti è pericoloso e rappresenta un grave rischio per la salute.

Published: Sep 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Modifica Piano Terapeutico web-based Praluent (alirocumab)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che è stato aggiornato il Piano Terapeutico web-based di Praluent (alirocumab) dedicato al monitoraggio di due specifiche indicazioni rimborsate.

Published: Sep 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web ed aggiornamento Registri di monitoraggio PREVYMIS Profilassi CMV

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 03/09/2025 è possibile utilizzare il medicinale Prevymis mediante registro di monitoraggio per la nuova indicazione ammessa alla rimborsabilità.

Published: Sep 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Interruption of the telephone switchboard service and the Farmaci-Line toll-free number

Users are advised that, due to technical problems, the switchboard number of the Italian Medicines Agency and the toll-free number of the Farmaci-Line service are currently not operational. To contact the switchboard, please call 0659784000. The Farmaci-Line service can be reached via the “Rexpondo” ticketing system.

Published: Sep 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Organismo Indipendente di Valutazione della Performace - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Organismo Indipendente di Valutazione della Performace".

Published: Sep 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 29/08/2025.

Published: Aug 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct communication with healthcare professionals on Lipidem

In stability studies, agglomerates of droplet-like structures were detected in individual batches of the finished medicinal product. These structures are composed of components of the emulsion and can form during the shelf life.

Published: Aug 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Aug 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 22/08/2025.

Published: Aug 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct communication with healthcare professionals on supply shortage Zypadhera

Zypadhera is in shortage since 2024. The shortage concerns all strengths of the medicine < 210 mg / 300 mg / 405 mg > and is expected to last until October 2025.

Published: Aug 21, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct communication with healthcare professionals on Evrysdi

A mandatory labelling statement has been mistakenly omitted from the EU product label and summary of product characteristics (SmPC) for Evrysdi 0.75 mg/ml powder for oral solution.

Published: Aug 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Codice disciplinare e codice di condotta - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Codice disciplinare e codice di condotta".

Published: Aug 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Aug 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 14/08/2025.

Published: Aug 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso di ripristino di tutte le funzionalità della piattaforma Spending-PHA

Si informa che dalle ore 16:00 di oggi 13 agosto 2025 sono ripristinate tutte le funzionalità della piattaforma Spending-PHA.

Published: Aug 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA aggiorna Circolare MdS n.9/1997 sulla presentazione delle domande di AIC dei medicinali

L’aggiornamento riguarda in particolare l’individuazione, identificazione e abilitazione all’accesso dei sistemi informativi dell’AIFA da parte dei soggetti interessati e la nomina dei procuratori speciali da parte degli stessi soggetti.

Published: Aug 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento schede di monitoraggio Registri antibiotici reserve

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che la Commissione Scientifica ed Economica del farmaco nella seduta del 19/05/2025, ha espresso parere favorevole a modificare i Registri di monitoraggio relativi agli antibiotici Reserve.

Published: Aug 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Alzheimer: ricerca, prospettive e strategie di cura

Due farmaci, lecanemab e, più recentemente, donanemab, hanno ottenuto il parere favorevole del Comitato per i medicinali per uso umano (CHMP) dell’Agenzia europea EMA per il trattamento di pazienti sintomatici con malattia di Alzheimer in fase iniziale.

Published: Aug 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 08/08/2025.

Published: Aug 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Aug 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Registri ORKAMBI, SYMKEVI, KALYDECO Fibrosi cistica

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 07.08.2025 terminerà il monitoraggio dei Registri di: Orkambi, Symkevi, Kalydeco per alcune specifiche indicazioni teraeutiche.

Published: Aug 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento schede di monitoraggio - Registro KAFTRIO in associazione con KALYDECO - Fibrosi cistica (F/G - F/RF - F/NON CLASS. F/NON IDENT)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 07/08/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in associazione a KALYDECO (ivacaftor) per una specifica indicazione terapeutica.

Published: Aug 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento schede di monitoraggio - Registro KAFTRIO in associazione con KALYDECO (Fibrosi cistica F/F, F/MF)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, dal 07/08/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in associazione a KALYDECO (ivacaftor) per una specifica indicazione terapeutica.

Published: Aug 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi politici, di amministrazione, di direzione o di governo - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Published: Aug 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Revision of AIFA Notes: repeal of Notes 2, 4 and 41

As of 7 August 2025, AIFA Notes 2, 4 and 41 are repealed.

Published: Aug 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso di sospensione temporanea di alcune funzionalità della piattaforma Spending-PHA

Si informa che, dalle ore 16:00 di oggi 6 agosto 2025 alle ore 16:00 di domani 7 agosto 2025, la piattaforma Spending-PHA sarà temporaneamente non disponibile, per consentire interventi di manutenzione tecnica programmata.

Published: Aug 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Report consultazione pubblica AIFA sui criteri di attribuzione dell’innovatività terapeutica

AIFA rende disponibile il report ricognitivo dei contributi, condivisi in forma anonimizzata, ricevuti da associazioni di pazienti, portatori di interessi e cittadini.

Published: Aug 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Aug 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Aug 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ruolo dirigenti e Atti generali - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Ruolo dirigenti e Atti generali".

Published: Aug 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Report sulla gestione della contaminazione da nitrosammine nei medicinali per uso umano da parte del network regolatorio europeo

L’AIFA informa che è stato pubblicato dall’EMA e dal CMDh il report relativo alla gestione della problematica inerente alle nitrosammine nei medicinali per uso umano da parte del network regolatorio europeo.

Published: Aug 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Aug 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 01/08/2025.

Published: Aug 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Biosimilar medicines in Italy: AIFA reports updated

The Agency publishes the reports on the monitoring of biosimilar drugs in Italy, updated to March 2025.

Published: Aug 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Italian Medicines Agency's online services will be unavailable due to scheduled maintenance

We inform users that AIFA's online services will be unavailable from Wednesday, August 06, 2025, from 12:30 PM to 1:30 PM.

Published: Aug 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Normativa / Agenzia Italiana del Farmaco - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Normativa - AIFA.

Published: Jul 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Jul 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ripiano della spesa farmaceutica per acquisti diretti per l’anno 2024 - Avvio del procedimento - Esposizione dati

L’Agenzia Italiana del Farmaco, ai sensi dell’art. 7 della Legge n. 241 del 1990, comunica l’avvio del procedimento di ripiano della spesa farmaceutica per acquisti diretti per l’anno 2024.

Published: Jul 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

List of class A and H medicinal products at 17 February 2025

AIFA makes available, to healthcare professionals, a list of class A and H medicinal products dispensed by the National Health Service, sorted by active ingredient and trade name.

Published: Jul 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Temporaneo malfunzionamento del numero verde Farmaci-Line

Informiamo i cittadini e gli operatori sanitari che, a causa di problemi tecnici che interessano la rete telefonica dell’Agenzia, il numero verde del servizio Farmaci-line è temporaneamente non disponibile.

Published: Jul 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA monitoring of final data for January-December 2024

Pharmaceutical expenditure for direct purchases by the Regions exceeds the budget by 4 billion.

Published: Jul 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Monitoring of Pharmaceutical expenditure - January / December 2024 (Final balance)

AIFA has published the documents relating to the monthly monitoring of national and regional pharmaceutical expenditure for the periods January / December 2024 (Final balance).

Published: Jul 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

IThe AIFA Board of Directors approves the reimbursability of 11 medicines, including the first gene therapy for haemophilia B

The National Health Service will reimburse the first one-shot treatment for severe and moderately severe haemophilia B, a rare and potentially fatal disease that causes bleeding in the joints, muscles and internal organs.

Published: Jul 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Jul 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Jul 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 25/07/2025.

Published: Jul 25, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esiti runione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile gli esiti dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 14-15-16-17-18 luglio 2025.

Published: Jul 25, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA 2025 call for proposals for independent research on rare diseases: 100 projects submitted, for a total funding of €17.8 million

“The first AIFA call for proposals dedicated exclusively to rare diseases closed with a round figure: 100 projects represent a great result, which testifies to the vitality and high level of Italian research, which responded with great interest,” emphasises Robert Nisticò, president of the Italian Medicines Agency.

Published: Jul 25, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Jul 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di posizioni dirigenziali sanitarie

Published: Jul 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Procedura di applicazione Managed Entry Agreement - CRYSVITA ipofosfatemia FGF23 correlata

Si informano gli utenti dei Registri di Monitoraggio AIFA che dal 24/07/2025 è attiva, sulla piattaforma dei Registri, la procedura telematica di applicazione dell’accordo di condivisione del rischio per il medicinale CRYSVITA per una specifica indicazione terapeutica.

Published: Jul 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro CRYSVITA ipofosfatemia FGF23 correlata

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 24/07/2025 è possibile utilizzare il medicinale CRYSVITA ipofosfatemia FGF23-correlata, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Jul 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registri CRYSVITA XLH 1-12aa e CRYSVITA XLH 13-65 aa

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 24/07/2025 sarà possibile utilizzare per le indicazioni di CRYSVITA tre nuove AIC.

Published: Jul 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Jul 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Hepatitis C: update of 21 July 2025 concerning enrolled patients

AIFA has published the updated weekly data concerning treatments with new second-generation direct acting antiviral agents (DAAs) for chronic hepatitis C, as collected by AIFA Monitoring registries.

Published: Jul 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro KAPRUVIA

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 23/07/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale KAPRUVIA per una specifica indicazione terapeutica.

Published: Jul 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento scheda Multifarmaco di monitoraggio semplificato intravitreali anti VEGF - RIMMYRAH

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 23.07.2025 è possibile selezionare, nella scheda multifarmaco di monitoraggio semplificato antiVEGF IVT, il medicinale RIMMYRAH (ranibizumab) per quattro specifiche indicazioni terapeutiche.

Published: Jul 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Sunset Clause - Warning di prossima decadenza del 22 luglio 2025

La comunicazione costituisce un pre-avviso di decadenza e contiene un elenco di medicinali in potenziale decadenza per mancata commercializzazione.

Published: Jul 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento: Modalità operative per le aziende titolari di AIC di medicinali a uso umano

Ad integrazione di quanto già comunicato con nota informativa del 18/06/2025 in merito alle modalità operative per l’implementazione del Decreto del Ministero della Salute 27 marzo 2025, si ritiene utile fornire ulteriori indicazioni relativamente agli effetti del decreto su altre classi di sostanze e relativi medicinali.

Published: Jul 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Farmaci per il trattamento del diabete mellito tipo 2: aggiornamento Nota AIFA 100

Modifiche alla prescrizione a partire dal 19 luglio 2025.

Published: Jul 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 18/07/2025.

Published: Jul 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Registri di monitoraggio dei PT web-based di Forxiga, Edistride e Jardiance

A partire dal 19-07-2025 terminerà il monitoraggio dei PT web-based delle glifozine dapagliflozin e empagliflozin (specialità medicinali FORXIGA, EDISTRIDE, JARDIANCE) per due  specifiche indicazioni terapeutiche.

Published: Jul 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Adozione delle istruzioni applicative relative alle procedure di rilascio dell’AIC e alle modalità per adempiere agli obblighi di legge, anche relativamente ai medicinali di importazione e distribuzione parallela

Con Determinazione DTS 56-2025 sono state adottate dall’Agenzia le istruzioni applicative relative alle procedure di rilascio dell'AIC e alle modalità per adempiere agli obblighi previsti dall’art. 4 del d.lgs. 6 febbraio 2025, n. 10, anche relativamente ai medicinali di importazione e distribuzione parallela.

Published: Jul 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct communication with healthcare professionals on risperidone-containing medicines

Risperidone-containing medicines 1 mg/mL in oral solution formulation: medication error associated with accidental overdose in children and adolescents.

Published: Jul 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA updates the Transparency Lists

AIFA has published the updated Transparency Lists of generic medicines together with the related reference prices, updated at 15 July 2025.

Published: Jul 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA and Istituto Poligrafico e Zecca dello Stato renew their cooperation

Among the objectives of the agreement are to ensure the continuity and efficiency of “TrovaNormeFarmaco”.

Published: Jul 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

IncreaseNET project. AIFA launches market investigation aimed at identifying Universities and Research Institutes for the provision of training courses on pharmaceutical innovation

The survey aims to identify university institutions and research institutes, public or private, to be entrusted with training courses for the benefit of regulatory agency experts in the field of two innovative and challenging topics in the pharmaceutical field.

Published: Jul 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA redefines the criteria for awarding the "innovativeness status" to medicines

Possible fast track for companies investing in preclinical and clinical research in Italy. Immediate access to the Innovativeness Fund for reserve antibiotics used against multi-resistant germs.

Published: Jul 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 July 2025

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 July 2025.

Published: Jul 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 11/07/2025.

Published: Jul 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 14-15-16-17-18 luglio 2025.

Published: Jul 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Atti degli Organismi indipendenti di valutazione - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Atti degli Organismi indipendenti di valutazione".

Published: Jul 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA ospita delegazione del Ministero della Salute greco per condividere esperienze e best practice sull’HTA

Presenti anche i rappresentanti della Commissione Europea e dell’OMS Europa.

Published: Jul 10, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Biosimilar medicines in Italy: AIFA reports updated

The Agency publishes the reports on the monitoring of biosimilar drugs in Italy, updated to February 2025.

Published: Jul 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Jul 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di posti di funzione dirigenziale di livello non generale. Rinnovo degli incarichi di direzione di: APA - CG - SAI

Rinnovo degli incarichi di direzione di: APA - CG - SAI.

Published: Jul 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esiti runione straordinaria Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile gli esiti dei lavori della riunione straordinaria della Commissione Scientifica e Economica (CSE) del 2 luglio 2025.

Published: Jul 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Jul 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA Board of Directors approves the reimbursability of 7 medicines

A new medicine for moderate to severe ulcerative colitis and new medicine indications for multiple sclerosis and cystic fibrosis are some of the treatments that will be reimbursed by the National Health Service (SSN).

Published: Jul 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Annual list of manufacturing sites authorized/registered for production/importation of active substances updated to June 30, 2025

List of manufacturing sites authorized/registered for production/importation of active substances and manufacturing sites registered for the production/importation of medical gases as active substances is available updated to June 30, 2025.

Published: Jul 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Temporanea interruzione del servizio di centralino telefonico

Si informa l’utenza che, a causa di un guasto tecnico, il centralino telefonico dell’Agenzia Italiana del Farmaco non è temporaneamente operativo. Nell’attesa che il servizio venga ripristinato, è possibile contattare il numero telefonico 0659784000.

Published: Jul 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 04/07/2025.

Published: Jul 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Jul 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di incarichi a dirigenti sanitari

Nelle more della definizione del nuovo assetto organizzativo interno dell’Agenzia, quale previsto dal D.M. 8 gennaio 2024, n. 3, sono in scadenza nel mese di agosto p.v. un incarico dirigenziale sanitario, fascia economica S2/S3, presso l'Area Strategia ed economia del farmaco e un incarico dirigenziale sanitario, fascia economica S2/S3, presso il Settore HTA ed economia del farmaco.

Published: Jul 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Jul 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

List of class A and H medicinal products at 15 January 2025

AIFA makes available, to healthcare professionals, a list of class A and H medicinal products dispensed by the National Health Service, sorted by active ingredient and trade name.

Published: Jul 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Canoni di locazione e affitto - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Canoni di locazione e affitto".

Published: Jul 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Jul 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Jul 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro AKEEGA (mCRPC)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 03/07/2025, è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale AKEEGA per una specifica indicazione terapeutica.

Published: Jul 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Adeguamento della tariffa unica per le sperimentazioni cliniche

Determina di aggiornamento della tariffa unica per le sperimentazioni cliniche, sulla base dell'indice ISTAT riferito al mese di dicembre 2023.

Published: Jul 2, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Hepatitis C: update of 30 June 2025 concerning enrolled patients

AIFA has published the updated weekly data concerning treatments with new second-generation direct acting antiviral agents (DAAs) for chronic hepatitis C, as collected by AIFA Monitoring registries.

Published: Jul 2, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Payment methods of the 2025 annual fee for Marketing Authorisations (MAs) valid as of 31 December 2024

Important information by the Italian Medicines Agency is available on the payment methods of the 2025 annual fee for Marketing Authorisations (MAs) valid as of 31 December 2024.

Published: Jul 2, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione nuova funzionalità per il trasferimento facilitato dei trattamenti

Si informano i Referenti regionali, i Direttori Sanitari Aziendali (DSA) e i Direttori Sanitari di Presidio (DS) che, a partire dal 01/07/2025 è disponibile sulla Piattaforma dei Registri di monitoraggio una nuova funzionalità “Trasferimento Trattamenti”.

Published: Jul 2, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct communication with healthcare professionals on MINIRIN

The permanent marketing cessation of the medicinal product MINIRIN/DDAVP 50 mcg/ml nasal spray, solution, AIC 023892033, is planned on October 1, 2025.

Published: Jul 2, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Authorisation for Conferences and Meetings - Essential Maintenance Activity

AIFA's online service Authorisation for Conferences and Meetings will be undergoing scheduled maintenance from 7:00 a.m. on Friday, 11 July until 7.00 a.m. on Monday, 14 July, 2025.

Published: Jul 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione straordinaria Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione straordinaria della Commissione Scientifica e Economica (CSE) del 2 luglio 2025.

Published: Jul 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito avviso per il conferimento del posto di funzione dirigenziale di livello non generale - Ufficio Affari amministrativi generali

Published: Jul 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Elenco delle officine autorizzate alla produzione di medicinali e delle officine autorizzate alla produzione di gas medicali al 30 giugno 2025

Elenco delle Officine autorizzate alla produzione di Medicinali e delle Officine autorizzate alla produzione di Gas medicali (esclusi gas registrati come materie prime), alla data del 30 giugno 2025.

Published: Jul 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Atti di concessione - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Atti di concessione".

Published: Jul 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi politici, di amministrazione, di direzione o di governo - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Published: Jul 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA Board approves reimbursement of two medicinal products

One new chemical entity and two extensions of therapeutic indications for a medicinal product already reimbursed for other indications.

Published: Jul 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Servizi in rete - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Servizi in rete".

Published: Jun 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento schede di monitoraggio Registri antibiotici reserve - Registro semplificato

Si informano gli utenti dei Registri di monitoraggio che, al fine di chiarire le modalità di compilazione dei Registri di monitoraggio semplificati relativi agli antibiotici reserve Recarbrio, Sivextro, Vaborem, Xerava, Zavicefta e Zerbaxa, riguardo la necessità di registrare le confezioni innovative erogate a partire dal 01/01/2025, sono stati aggiornati i testi fissi in scheda di eleggibilità, richiesta farmaco e dispensazione farmaco.

Published: Jun 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA Board of Directors approves the reclassification of glifozines in class A of reimbursed products that can be purchased in pharmacies

Green light also for the repeal of the Therapeutic Plans for the same class of medicines, used against diabetes, severe heart failure and chronic renal failure.

Published: Jun 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Payment of revenue stamp due for issuance of final decision on marketing authorisation procedures

Payment of revenue stamp due for issuance of final decision on marketing authorisation procedures.

Published: Jun 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 27/06/2025.

Published: Jun 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esiti runione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile gli esiti dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 16-17-18-19-20 giugno 2025.

Published: Jun 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Jun 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Online il Rapporto Vaccini

Dati e analisi sulle segnalazioni inserite nella Rete Nazionale di Farmacovigilanza (RNF) nel 2023.

Published: Jun 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 2006/2025.

Published: Jun 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Atti di concessione - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Atti di concessione".

Published: Jun 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Modalità operative per le aziende titolari di AIC di medicinali a uso umano

Si informano i titolari di AIC di medicinali per uso umano che il decreto del Ministero della Salute 27 marzo 2025 ha introdotto nuove disposizioni per i medicinali contenenti principi attivi appartenenti alla classe S9 Glucocorticoidi, somministrati per via inalatoria e topica.

Published: Jun 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro VYDURA

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 18/06/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale VYDURA per una specifica indicazione terapeutica.

Published: Jun 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - PT web VYDURA-TRATTAMENTO ACUTO

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 18/06/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale VYDURA per una specifica indicazione terapeutica.

Published: Jun 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Jun 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Jun 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso relativo all’attivazione di comandi obbligatori presso AIFA - Anno 2025

L'avviso è finalizzato all'acquisizione di manifestazioni di interesse al collocamento in posizione di comando obbligatorio presso l'Agenzia Italiana del Farmaco.

Published: Jun 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito avviso per il conferimento di posti di funzione dirigenziale di livello non generale. Rinnovo degll'incarico di direzione del Settore HTA ed economia del farmaco

Si informa che la procedura di interpello per il conferimento del posto di funzione dirigenziale di livello non generale del Settore HTA ed economia del farmaco, è revocata.

Published: Jun 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Translarna for Duchenne muscular dystrophy, patients already undergoing treatment can import the medicine from abroad at no cost to them

Decision signed after revocation of the marketing authorisation by the EU Commission.

Published: Jun 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Jun 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA updates the Transparency Lists

AIFA has published the updated Transparency Lists of generic medicines together with the related reference prices, updated at 16 June 2025.

Published: Jun 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro FABHALTA

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale FABHALTA per una specifica indicazione terapeutica.

Published: Jun 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Costi contabilizzati - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Costi contabilizzati".

Published: Jun 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 13/06/2025.

Published: Jun 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio ZERBAXA - Registro semplificato

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 13/06/2025 è stato istituito il Registro di monitoraggio per il medicinale ZERBAXA per una specifica indicazione terapeutica rimborsata a carico del SSN.

Published: Jun 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio ZAVICEFTA - Registro semplificato

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 13/06/2025 è stato istituito il Registro di monitoraggio per il medicinale ZAVICEFTA per una specifica indicazione terapeutica rimborsata a carico del SSN.

Published: Jun 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio XERAVA - Registro semplificato

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 13/06/2025 è stato istituito il Registro di monitoraggio per il medicinale XERAVA per una specifica indicazione terapeutica rimborsata a carico del SSN.

Published: Jun 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio VABOREM - Registro semplificato

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 13/06/2025 è stato istituito il Registro di monitoraggio per il medicinale VABOREM per una specifica indicazione terapeutica rimborsata a carico del SSN.

Published: Jun 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio SIVEXTRO - Registro semplificato

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 13/06/2025 è stato istituito il Registro di monitoraggio per il medicinale SIVEXTRO per una specifica indicazione terapeutica rimborsata a carico del SSN.

Published: Jun 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio RECARBRIO - Registro semplificato

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 13/06/2025 è stato istituito il Registro di monitoraggio per il medicinale RECARBRIO per una specifica indicazione terapeutica rimborsata a carico del SSN.

Published: Jun 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dati ulteriori - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dati ulteriori ".

Published: Jun 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Precisazioni sulle modalità di sottomissione di variazioni I e II presentate come Worksharing o Super-grouping sui servizi Online di AIFA

Si portano all’attenzione di tutte le aziende farmaceutiche alcuni chiarimenti in merito alla presentazione delle variazioni dei termini di un’Autorizzazione all’Immissione in Commercio (AIC) per medicinali autorizzati secondo procedura nazionale o di mutuo riconoscimento/decentrata (MR/DC).

Published: Jun 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ruolo dirigenti e Atti generali - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Ruolo dirigenti e Atti generali".

Published: Jun 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dati relativi ai premi - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dati relativi ai premi".

Published: Jun 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 16-17-18-19-20 giugno 2025.

Published: Jun 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Jun 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Tassi di assenza - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Tassi di assenza".

Published: Jun 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Commercializzazione dei farmaci per i medicinali di importazione parallela

Determina DTS/15/2025 di rettifica della Determinazione DG/8/2022 in materia di commercializzazione dei farmaci per i medicinali di importazione parallela.

Published: Jun 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Personale non a tempo indeterminato - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Personale non a tempo indeterminato".

Published: Jun 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi politici, di amministrazione, di direzione o di governo - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Published: Jun 10, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Canoni di locazione e affitto - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Canoni di locazione e affitto".

Published: Jun 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Jun 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

The 2025 Independent Research Call on rare diseases is online

Researchers may submit their proposals electronically starting at 10:00 a.m. on Monday, 9 June 2025.

Published: Jun 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Reducing the environmental impact of medicinal products: some activities proposed by European expert working group

The Report was presented at the European Commission Pharmaceutical Committee.

Published: Jun 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) - 2-5 june 2025

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) - 2-5 june 2025.

Published: Jun 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ricognizione medicinali relativamente a officina farmaceutica: Nectar Life Sciences Limited (India)

Si chiede alle Aziende di verificare se, per i medicinali autorizzati per il mercato italiano e/o prodotti per l’esportazione, risulti presente come produttore autorizzato di sostanze attive/intermedi l’officina farmaceutica: Nectar Life Sciences Limited, Unit II, Village Saidpura, Tehsil Dera Bassi, Sahibzada Ajit Singh Nagar, 140 507 India.

Published: Jun 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 06/06/2025.

Published: Jun 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti sanitari - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti sanitari".

Published: Jun 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Tassi di assenza - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Tassi di assenza".

Published: Jun 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Jun 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Piano e Relazione sulla performance - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Piano e Relazione sulla performance".

Published: Jun 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Important update from the PRAC about Ozempic, Rybelsus and Wegovy (semaglutide)

NAION (non-arteritic anterior ischemic optic neuropathy), a serious ocular condition that may cause loss of vision or rapidly worsening eyesight, is a very rare side effect of these medicines.

Published: Jun 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Jun 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

List of innovative drugs by single indication (2024)

At the conclusion of the “Procedure for the revision and validation of the lists of therapeutic indications for innovative medicines by pharmaceutical companies”, the Agency has drawn up a list of medicines which have been recognised as having the requirement of (full) therapeutic innovativeness, for at least one indication.

Published: Jun 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Jun 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Jun 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento del posto di funzione dirigenziale di livello non generale - Ufficio Affari amministrativi generali

Si procede alla pubblicità delle posizioni per il conferimento dell’incarico dirigenziale di livello non generale di direzione dell’Ufficio Affari Amministrativi Generali.

Published: Jun 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Misure correttive per ridurre la presenza di nitrosammine nei medicinali

Si informano i titolari dei medicinali per uso umano che nel press release della seduta del CMDh di maggio 2025 è stato riportato un avviso in merito all'implementazione delle misure correttive necessarie per ridurre la presenza di nitrosammine nei medicinali.

Published: Jun 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA launches the 2025 Independent Research Call on rare diseases

For the promotion of studies on low-prevalence diseases, which often do not attract significant commercial investment.

Published: Jun 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Modifica Registro KALYDECO (FC)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, è stato aggiornato il Registro di Monitoraggio di KALYDECO dedicato al monitoraggio di due specifiche indicazioni terapeutica.

Published: Jun 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Jun 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 30/05/2025.

Published: May 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione straordinaria Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione straordinaria della Commissione Scientifica e Economica (CSE) del 3 giugno 2025.

Published: May 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esiti runione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile gli esiti dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 19-20-21-22-23 maggio 2025.

Published: May 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Map of Clinical Trial Sites

The new map of clinical trial sites, accessible from the public website of the Clinical Trials Information System (CTIS), is now also accessible from the AIFA institutional website.

Published: May 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: May 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: May 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito della procedura di interpello per il conferimento di incarico a dirigenti sanitari

Informativa sull’esito della procedura di interpello per il conferimento di incarichi a dirigenti sanitari, di cui all'avviso dell'8 aprile 2025, prot. n. 43434 -AIFA-UTG-P.

Published: May 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: May 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct communication with healthcare professionals on Mysimba (naltrexone/bupropione)

AIFA, in agreement with the European Medicines Agency and the Marketing Authorisation Holder, informs the Healthcare Professionals on the new recommendations for use of the medicinal product Mysimba, indicated for the management of weight adult patients with obesity or in the presence of weight-related comorbidities.

Published: May 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio SPEXOTRAS - FINLEE (LGG) - Registro semplificato

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 28/05/2025 è stato istituito il Registro di monitoraggio per i medicinali SPEXOTRAS - FINLEE in una specifica indicazione terapeutica rimborsata a carico del Servizio sanitario nazionale.

Published: May 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio SPEXOTRAS - FINLEE (HGG) - Registro semplificato

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 28/05/2025 è stato istituito il Registro di monitoraggio per i medicinali SPEXOTRAS - FINLEE in una specifica indicazione terapeutica rimborsata a carico del Servizio sanitario nazionale.

Published: May 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio SPEVIGO - Registro semplificato

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 28/05/2025 è stato istituito il Registro di monitoraggio per il medicinale SPEVIGO in una specifica indicazione terapeutica rimborsata a carico del Servizio sanitario nazionale.

Published: May 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio DUPIXENT (PN) - Registro semplificato

Published: May 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio CABOMETYX (DTC) - Registro semplificato

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 28/05/2025 è stato istituito il Registro di monitoraggio per il medicinale CABOMETYX in una specifica indicazione terapeutica rimborsata a carico del Servizio sanitario nazionale.

Published: May 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Atti amministrativi generali - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Atti amministrativi generali".

Published: May 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Prevenzione della Corruzione - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Prevenzione della Corruzione".

Published: May 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Piano e Relazione sulla performance - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Piano e Relazione sulla performance".

Published: May 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: May 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Piano triennale per prevenzione della corruzione e della trasparenza - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Piano triennale per prevenzione della corruzione e della trasparenza".

Published: May 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Nisticò: "Medicina di precisione e prescrittomica per migliorare l’efficacia e ridurre gli effetti collaterali delle terapie, ottimizzando le risorse”

Lo ha affermato il Presidente dell’AIFA Robert Nisticò nel suo intervento odierno alla Tavola rotonda “Verso la medicina di precisione”, organizzato presso la Camera dei Deputati dall’Ordine dei medici di Roma.

Published: May 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: May 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione straordinaria Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione straordinaria della Commissione Scientifica e Economica (CSE) del 27 maggio 2025.

Published: May 26, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 23/05/2025.

Published: May 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: May 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

List of class A and H medicinal products at 16 December 2024

AIFA makes available, to healthcare professionals, a list of class A and H medicinal products dispensed by the National Health Service, sorted by active ingredient and trade name.

Published: May 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Managed Entry Agreements (MEA) Registro MAVIRET

Si informano gli utenti dei Registri dei Farmaci sottoposti a monitoraggio che, a partire dal 20/05/2025, i Managed Entry Agreements (MEA), non sono più attive per il registro MAVIRET per una specifica indicazione terapeutica.

Published: May 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Registro di monitoraggio SOLIRIS (SEUa)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 20/05/2025, termina il monitoraggio del Registro SOLIRIS per due specifiche indicazioni terapeutiche.

Published: May 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio MAVIRET (HCV) - Registro semplificato

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 20/05/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale MAVIRET per una specifica indicazione terapeutica.

Published: May 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Registro di monitoraggio SOLIRIS (EPN)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 20/05/2025, termina il monitoraggio del Registro SOLIRIS per una specifica indicazione terapeutica.

Published: May 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro SOLIRIS (MGg est.)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 20/05/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale SOLIRIS per una specifica indicazione terapeutica.

Published: May 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro RYSTIGGO (MGg)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 20/05/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale RYSTIGGO per una specifica indicazione terapeutica.

Published: May 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro IQIRVO

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 20/05/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale IQIRVO per una specifica indicazione terapeutica.

Published: May 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro ELREFXIO

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 20/05/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale ELREFXIO per una specifica indicazione terapeutica.

Published: May 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: May 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 16/05/2025.

Published: May 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 19-20-21-22-23 maggio 2025.

Published: May 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro IMCIVREE (POMC)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 16/05/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale IMCIVREE per una specifica indicazione terapeutica.

Published: May 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro IMCIVREE (BBS)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 16/05/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale IMCIVREE per una specifica indicazione terapeutica.

Published: May 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro ALECENSA ADIUVANTE (NSCLC)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 16/05/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale ALECENSA per una specifica indicazione terapeutica.

Published: May 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Eugenia Cogliandro elected Chair of the European Pharmacopoeia Commission

She will take up her duties during the 182nd session of the EPC on 17 June 2025, for a three-year term.  

Published: May 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

AIFA updates the Transparency Lists

AIFA has published the updated Transparency Lists of generic medicines together with the related reference prices, updated at 15 May 2025.

Published: May 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Il CdA AIFA approva la rimborsabilità di 11 farmaci

Sono un medicinale orfano, 4 nuove molecole chimiche, 2 generici, un farmaco di importazione parallela e 3 estensioni di indicazioni terapeutiche. 

Published: May 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: May 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

List of class A and H medicinal products at 15 October 2024

AIFA makes available, to healthcare professionals, a list of class A and H medicinal products dispensed by the National Health Service, sorted by active ingredient and trade name.

Published: May 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avvio del procedimento di Pay-Back convenzionata 1,83% e della procedura di retrocessione - 2° semestre 2024

Si informano le aziende farmaceutiche che dalle ore 16:00 del 13 maggio 2025 sarà attivo il servizio online “Spending-Pha” per la gestione del procedimento di payback 1,83% II semestre 2024.

Published: May 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avvio del procedimento di Pay-Back convenzionata 1,83% e della procedura di retrocessione - 2° semestre 2024

Si informano le aziende farmaceutiche che dalle ore 16:00 del 13 maggio 2025 sarà attivo il servizio online “Spending-Pha” per la gestione del procedimento di payback 1,83% II semestre 2024.

Published: May 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Nisticò (AIFA): “High drug prices in the US as a result of a fully privatised healthcare system”

“The higher prices of medicines in the United States, condemned by President Trump, are the result of a fully privatised system that contributes to increasing all items of health expenditure. On the contrary, our National Health Service, also thanks to AIFA’s work, is able to obtain among the most favourable prices for medicines among OECD countries”, said AIFA’s President Robert Nisticò.

Published: May 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Direct communication with healthcare professionals on Kisqali (ribociclib)

The Italian Medicines Agency (AIFA), in collaboration with the European Medicines Agency (EMA), communicates a change in the storage conditions and the validity period of the medicine Kisqali (ribociclib).

Published: May 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

EU regulators agree workplan to optimise use of data and artificial intelligence (AI)

Leveraging the power of data for public and animal health.

Published: May 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 09/05/2025.

Published: May 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dati sui pagamenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dati sui pagamenti".

Published: May 9, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines

Following an EU-wide review of available data on finasteride and dutasteride medicines, EMA’s safety committee, PRAC, has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1 and 5 mg tablets.

Published: May 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

EMA starts review of Ixchiq (live attenuated chikungunya vaccine)

MA’s safety committee (PRAC) has started a review of Ixchiq (a live attenuated chikungunya vaccine) following reports of serious adverse events in elderly people. 

Published: May 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: May 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di posti di funzione dirigenziale di livello non generale. Rinnovo dell’incarico di direzione del Settore HTA ed economia del farmaco

Rinnovo dell'incarico di direzione del Settore HTA ed economia del farmaco.

Published: May 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: May 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Bilanci AIFA - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Bilanci AIFA".

Published: May 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Innovative medicines list: AIFA publishes April 2025 update

AIFA updates the list of medicines that, in the opinion of the Scientific and Economic Committee for Medicines (CSE), meet the requirement of full or conditional therapeutic innovativeness.

Published: May 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: May 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ruolo dirigenti e Atti generali - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Ruolo dirigenti e Atti generali".

Published: May 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito avviso per il conferimento del posto di funzione dirigenziale di livello non generale - Ufficio Gestione dei segnali e Ufficio Ispezioni GCP

Si informa che le procedure di interpello per il per il conferimento del posto di funzione dirigenziale di livello non generale di direzione dell’Ufficio Gestione dei segnali e dell’Ufficio Ispezioni GCP si sono concluse con il conferimento degli incarichi dirigenziali, rispettivamente, alla dott.ssa Luisa Stoppa e al dott. Fabrizio Sacco.

Published: May 2, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 02/05/2025.

Published: May 2, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro MULTIFARMACO PPP, per i farmaci sottoposti a programma di prevenzione della gravidanza

Published: Apr 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Registro RONAPREVE profilassi COVID-19

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 30/04/2025 termina il monitoraggio del Registro RONAPREVE per una specifica indicazione terapeutica.

Published: Apr 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Biosimilar medicines in Italy: AIFA reports updated

The Agency publishes the reports on the monitoring of biosimilar drugs in Italy, updated to December 2024.

Published: Apr 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Indicatore di tempestività dei pagamenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Indicatore di tempestività dei pagamenti".

Published: Apr 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Apr 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Monitoring of Pharmaceutical expenditure (January / December 2024)

AIFA has published the documents relating to the monthly monitoring of national and regional pharmaceutical expenditure for the periods January / December 2024.

Published: Apr 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Pharmaceutical expenditure for direct purchases by the Regions slows in the last months of the year but it exceeds the 2024 ‘ceiling’ by 3.6 billion

Considering that several medicines shifted from the innovative fund to the direct purchases one, the trend is in line with previous years. For the NHS approved care regime there was a surplus of 651 million.

Published: Apr 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Nota Informativa Importante su Livopan

LIVOPAN: Rischio di perdita di gas e interruzione dell'erogazione di gas al paziente dovuti al congelamento della valvola quando la portata è superiore a 8 l/min sul connettore Fir Tree per flusso continuo.

Published: Apr 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Nota Informativa Importante su Lipovan

Published: Apr 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro TALZENNA (mCRPC)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 25/04/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale TALZENNA per una specifica indicazione terapeutica.

Published: Apr 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 24/04/2025.

Published: Apr 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Apr 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Direct communication with healthcare professionals on Opzelura (ruxolitinib)

Complaints about the presence of small, visible crystal-like particles in Opzelura (ruxolitinib) cream have been reported. The particles might form out of the active ingredient (ruxolitinib, as the dihydrate).

Published: Apr 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Modifica Registri Aimovig, Ajovy, Aquipta, Emgality e Vyepti (emicrania)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che,  sono stati aggiornati il Registri di Aimovig, Ajovy, Aquipta, Emgality e Vyepti dedicati al monitoraggio di una specifica indicazione terapeutica.

Published: Apr 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Inserimento nuove AIC - Registro Ajovy

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 23/04/2025 sarà possibile utilizzare per l’indicazione di AJOVY uno specifico trattamento.

Published: Apr 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Missione istituzionale a Londra per i vertici AIFA

Il Presidente Nisticò: “Gettiamo le basi per una maggior collaborazione sulla ricerca clinica, l’accesso all’innovazione e la sicurezza dei farmaci”.

Published: Apr 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Comunicazione AIFA su Barbesaclone 25 mg

Nuove e importanti informazioni relative alla produzione e alla distribuzione del medicinale a denominazione generica Barbesaclone 25 mg compresse rivestite - PROROGA SCADENZA.

Published: Apr 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Sunset Clause - Warning di prossima decadenza del 22 aprile 2025

La comunicazione costituisce un pre-avviso di decadenza e contiene un elenco di medicinali in potenziale decadenza per mancata commercializzazione.

Published: Apr 23, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro JEMPERLI - Paziente candidabile terapia sistemica (CE)

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 19/04/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale JEMPERLI per una specifica indicazione terapeutica.

Published: Apr 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Registro di monitoraggio STRIMVELIS

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 20/04/2025 termina il monitoraggio del Registro STRIMVELIS per una specifica indicazione terapeutica.

Published: Apr 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Managed Entry Agreements (MEA) Registro STRIMVELIS

Si informano gli utenti dei Registri dei Farmaci sottoposti a monitoraggio che, a partire dal 20/04/2025, le procedure di applicazione degli accordi di condivisione del rischio, ovvero i Managed Entry Agreements (MEA), non sono più attive per il registro STRIMVELIS per una specifica indicazione terapeutica.

Published: Apr 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione della prescrizione informatizzata tramite il sistema TS del nuovo principio attivo tirzepatide in Nota 100

Si comunica che è stata attivata la prescrizione informatizzata, tramite il sistema Tessera Sanitaria (TS), del medicinale MOUNJARO (tirzepatide).

Published: Apr 22, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esiti runione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile gli esiti dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 7-8-9-10-11 aprile 2025.

Published: Apr 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Modalità di versamento della Tariffa Unica per la sperimentazione clinica

Si forniscono informazioni sulle modalità di versamento della tariffa unica per la sperimentazione clinica (D.M. 30 gennaio 2023).

Published: Apr 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 18/04/2025.

Published: Apr 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Procedura di revisione e validazione degli elenchi delle indicazioni terapeutiche per fProcedure for the review and validation of lists of therapeutic indications for innovative medicines by pharmaceutical companiesarmaci innovativi da parte delle Aziende

The list of medicines that were recognised as innovative in 2024 has been made available only for marketing authorisation holders of medicines with full innovativeness status.

Published: Apr 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Apr 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

"Horizon Scanning: scenario dei medicinali in arrivo”. AIFA pubblica il Rapporto 2025

Il Rapporto Horizon Scanning ha lo scopo di fornire informazioni sui nuovi medicinali e sulle nuove indicazioni che hanno ricevuto un parere positivo dell’Agenzia Europea per i Medicinali (EMA) nel 2024 o che potrebbero riceverlo nell’anno in corso.

Published: Apr 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Payback convenzionata 1,83%: Procedura di revisione dell’anagrafica dei medicinali movimentati nel corso del II semestre dell’anno 2024

Si informano le aziende farmaceutiche che, dalle ore 16:00 del 16 aprile p.v., sarà attivo il servizio online “Spending-Pha” per la procedura di revisione dell’anagrafica dei medicinali oggetto del procedimento di payback 1,83% II semestre 2024.

Published: Apr 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Nomina dei componenti esterni del Comitato per la Valutazione dei Conflitti d’Interessi (CoVCI) dell’Agenzia Italiana del Farmaco

Con Determina Presidenziale 545/2025 sono stati nominati i componenti esterni del Comitato per la Valutazione dei Conflitti d’Interessi.

Published: Apr 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

“Spending-Pha”: nuovo servizio online AIFA per la gestione del procedimento di payback 1,83%

L’AIFA mette a disposizione delle aziende farmaceutiche titolari di AIC il servizio online “Spending-Pha” per la gestione del procedimento di payback 1,83%.

Published: Apr 16, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione straordinaria Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione straordinaria della Commissione Scientifica e Economica (CSE) del 16 aprile 2025.

Published: Apr 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Tavolo tecnico AIFA-Regioni: condiviso metodo di calcolo sull’impatto economico di classe delle glifozine

Il confronto con le Regioni proseguirà sui dati di spesa elaborati in seguito alla conclusione dell’iter di rinegoziazione dei prezzi di questa classe di medicinali.

Published: Apr 15, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

AIFA updates the Transparency Lists

AIFA has published the updated Transparency Lists of generic medicines together with the related reference prices, updated at 14 April 2025.

Published: Apr 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento della composizione del "Tavolo Tecnico di Coordinamento AIFA - Regioni"

Si rende noto che con Determinazione del Direttore tecnico-scientifico dell’AIFA n. 29 dell’11 aprile 2025, è stata aggiornata la composizione del Tavolo Tecnico di Coordinamento AIFA-Regioni.

Published: Apr 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Apr 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 11/04/2025.

Published: Apr 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Il CdA AIFA approva il bando di ricerca indipendente per il 2025 sulle malattie rare

Rivolto a tutti i ricercatori italiani di enti e istituzioni che intendano condurre studi non a fini commerciali.

Published: Apr 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

AIFA Board of Directors approves the reimbursability of 2 medicines

At its extraordinary meeting on 10 April 2025, the Board of Directors of the Italian Medicines Agency decided that an orphan medicine and a new chemical molecule should be eligible for reimbursement by the National Health Service (NHS).

Published: Apr 10, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Apr 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di incarico a dirigenti sanitari

Si procede alla pubblicità per il conferimento dell'incarico dirigenziale sanitario.

Published: Apr 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Apr 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Il CCNCE ha aggiornato le Linee di indirizzo per la raccolta del consenso informato

Il Centro di Coordinamento nazionale dei comitati etici ha recentemente aggiornato l'Allegato 2, a pagina 46, delle "Linee di Indirizzo per la raccolta del consenso informato alla partecipazione a sperimentazioni cliniche".

Published: Apr 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Apr 8, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento del posto di funzione dirigenziale di livello non generale - Ufficio Gestione dei segnali e Ufficio Ispezioni GCP

Si procede alla pubblicità delle posizioni per il conferimento degli incarichi dirigenziali di livello non generale di direzione dell’Ufficio Gestione dei segnali e dell’Ufficio Ispezioni GCP.

Published: Apr 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Innovative medicines list: AIFA publishes March 2025 update

AIFA updates the list of medicines that, in the opinion of the Scientific and Economic Committee for Medicines (CSE), meet the requirement of full or conditional therapeutic innovativeness.

Published: Apr 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Applicazione delle disposizioni normative in tema di maggiorazione della quota di spettanza a favore dei grossisti

Il valore della quota pari allo 0,65% del prezzo al pubblico del medicinale si intende trasferito dal titolare dell’Autorizzazione all’Immissione in Commercio (AIC) al grossista esclusivamente per i medicinali rimborsati dal Servizio Sanitario Nazionale (SSN), di cui alla fascia A, che vengono erogati nell’ambito del canale distributivo relativo all’assistenza farmaceutica convenzionata.

Published: Apr 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ruolo dirigenti e Atti generali - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Ruolo dirigenti e Atti generali".

Published: Apr 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Interactive OsMed: available online the update on consumption and pharmaceutical expenditure in Italy

With just a few clicks, users can access, select and compare tables and graphs from the latest edition of the OsMed Report.

Published: Apr 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Modifica Registro TECENTRIQ ADIUVANTE (NSCLC)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, è stato aggiornato il Registro di Monitoraggio di TECENTRIQ dedicato al monitoraggio di una specifica indicazione terapeutica.

Published: Apr 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Biosimilar medicines in Italy: AIFA reports updated

Published: Apr 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 04/04/2025.

Published: Apr 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Registro di monitoraggio XALKORI (ALK)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 23/03/2025 termina il monitoraggio del Registro XALKORI per per due specifiche indicazioni terapeutiche.

Published: Apr 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro MULTIFARMACO PPP, per i farmaci sottoposti a programma di prevenzione della gravidanza

Published: Apr 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Monitoring of Pharmaceutical expenditure (January / November 2024)

AIFA has published the documents relating to the monthly monitoring of national and regional pharmaceutical expenditure for the periods January / November 2024.

Published: Apr 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 07-08-09-10-11 aprile 2025.

Published: Apr 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA ospita il primo workshop 2025 dell’HMA Permanent Secretariat

Nisticò: “Importante fare rete su temi strategici”.

Published: Apr 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Titolari di incarichi politici, di amministrazione, di direzione o di governo - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Published: Apr 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Apr 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ripiano dello sfondamento del tetto della spesa farmaceutica per gli acquisti diretti per l'anno 2023 - Aggiornamento pagamenti

Si comunica che, dall'entrata in vigore del provvedimento di ripiano di cui alla determina AIFA n. 205/2025, sul totale dovuto e pari ad euro 1.640.532.614,00, è stato corrisposto ad oggi l'importo di euro 1.610.656.451,32, pari al 98,18%. Il residuo attualmente dovuto risulta pari ad euro 29.876.162,30.

Published: Apr 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 17-18-19-20-21 marzo 2025.

Published: Apr 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA Board approves reimbursement of 10 drugs

Orphan drugs for rare diseases (1), new chemical molecules (1), generic medicines (3) and extensions of therapeutic indications (5).

Published: Apr 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Communication on the national management of Follow-UP questionnaires

Following the publication by the European Medicines Agency (EMA) of the ‘Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)’, effective from 1 February 2025, the Italian Medicines Agency (AIFA) would like to provide clarification on the nature and management of the Specific AR FUQs.

Published: Apr 2, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Trova Norme Farmaco per la consultazione delle determine AIFA

Il portale Trova Norme Farmaco (TNF), sviluppato da AIFA in collaborazione con l’Istituto Poligrafico e Zecca dello Stato e accessibile anche dal sito istituzionale dell’Agenzia, amplia la propria operatività con l’obiettivo di semplificare e automatizzare i processi di pubblicazione dei provvedimenti dell’Agenzia e favorirne la consultazione.

Published: Apr 2, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Apr 2, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Hepatitis C: update of 31 March 2025 concerning enrolled patients

AIFA has published the updated weekly data concerning treatments with new second-generation direct acting antiviral agents (DAAs) for chronic hepatitis C, as collected by AIFA Monitoring registries.

Published: Apr 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Tariffe ISTAT

Si avvisano le Aziende che, dal 1° aprile 2025, le tariffe contenute nell’allegato 1 del D.M. 6 dicembre 2016 sono automaticamente aggiornate sulla base dell'indice ISTAT.

Published: Apr 1, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento Registro MULTIFARMACO PPP, per i farmaci sottoposti a programma di prevenzione della gravidanza

Published: Mar 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione straordinaria Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione straordinaria della Commissione Scientifica e Economica (CSE) del 31 marzo 2025.

Published: Mar 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

EMA concludes review of weight management medicine Mysimba

EMA’s human medicines committee (CHMP) has finalised its review of Mysimba (naltrexone / bupropion), a medicine used for weight management in adults, concerning the potential long-term cardiovascular risk.

Published: Mar 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 28/03/2025.

Published: Mar 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Mar 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito avviso per il conferimento del posto di funzione dirigenziale di livello non generale - Ufficio Sperimentazione Clinica e Ufficio Farmacovigilanza

Si informa che le procedure di interpello per il conferimento del posto di funzione dirigenziale di livello non generale dell’Ufficio Sperimentazione Clinica e dell’Ufficio Farmacovigilanza, si sono concluse con il conferimento, rispettivamente, al dott. Fabrizio Galliccia e alla dott.ssa Laura Sottosanti, dirigenti di ruolo dell’Agenzia Italiana del Farmaco.

Published: Mar 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Hepatitis C: update of 24 March 2025 concerning enrolled patients

AIFA has published the updated weekly data concerning treatments with new second-generation direct acting antiviral agents (DAAs) for chronic hepatitis C, as collected by AIFA Monitoring registries.

Published: Mar 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Modulo richiesta proroga documentazione integrativa prima LoQ - AIC nazionale

Published: Mar 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti sanitari - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti sanitari".

Published: Mar 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Mar 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Mar 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esiti avviso per il conferimento di posti di funzione dirigenziale di livello non generale. Rinnovo degli incarichi di direzione di: AAM - AVPM - AISP - ISF - IS

Si informa che la procedura di interpello per il conferimento di posti di funzione dirigenziale di livello non generale si è conclusa.

Published: Mar 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro OPDIVO NEOADIUVANTE (NSCLC)

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 25/03/2025 è possibile utilizzare il medicinale OPDIVO, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Mar 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro OPDIVO (melanoma adiuvante)

Published: Mar 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso pubblico per la nomina dei componenti esterni del Comitato per la valutazione dei conflitti d’interessi

E’ indetta una procedura per l'acquisizione di manifestazioni d'interesse finalizzata alla nomina dei componenti esterni del Comitato per la Valutazione dei Conflitti d’Interessi (CoVCI).

Published: Mar 26, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 21/03/2025.

Published: Mar 21, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Managed Entry Agreements (MEA) Registro VOSEVI

Si informano gli utenti dei Registri dei Farmaci sottoposti a monitoraggio che, a partire dal 21/03/2025, le procedure di applicazione degli accordi di condivisione del rischio, ovvero i Managed Entry Agreements (MEA), non sono più attive per il registro VOSEVI per una specifica indicazione terapeutica.

Published: Mar 21, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio VOSEVI (HCV) - Registro semplificato

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 21/03/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale VOSEVI per una specifica indicazione terapeutica.

Published: Mar 21, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro TALVEY

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 21/03/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale TALVEY per una specifica indicazione terapeutica.

Published: Mar 21, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA pubblica il monitoraggio delle estensioni di indicazione e posologia approvate da EMA

Il documento illustra il monitoraggio condotto su tutte le variazioni relative a nuove indicazioni terapeutiche e/o nuove posologie approvate nel corso del 2023.

Published: Mar 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Mar 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Mar 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Online il nuovo “Regolamento per la prevenzione e gestione dei conflitti di interesse all’interno dell’Agenzia Italiana del Farmaco”

Adottato dal Consiglio di amministrazione dell'AIFA con delibera n. 9 del  12 febbraio 2025.

Published: Mar 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Hepatitis C: update of 17 March 2025 concerning enrolled patients

AIFA has published the updated weekly data concerning treatments with new second-generation direct acting antiviral agents (DAAs) for chronic hepatitis C, as collected by AIFA Monitoring registries.

Published: Mar 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA updates the Transparency Lists

AIFA has published the updated Transparency Lists of generic medicines together with the related reference prices, updated at 17 March 2025.

Published: Mar 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti dirigenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti dirigenti".

Published: Mar 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - PT web EDISTRIDE (MRC)

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 15/03/2025 è possibile utilizzare il medicinale EDISTRIDE, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Mar 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro EDISTRIDE (MRC)

Published: Mar 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - PT web EDISTRIDE (HF)

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 15/03/2025 è possibile utilizzare il medicinale EDISTRIDE, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Mar 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro EDISTRIDE (HF)

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 15/03/2025 è possibile utilizzare il medicinale EDISTRIDE, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Mar 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Mar 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Mar 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esito avviso per il conferimento del posto di funzione dirigenziale di livello non generale - Ufficio Ispezioni GVP

Si informa che la procedura di interpello per il conferimento del posto di funzione dirigenziale di livello non generale dell’Ufficio Ispezioni GVP, si è conclusa con il conferimento, ai sensi dell'art. 19, comma 5, d.lgs. 165/2001, dell’incarico dirigenziale alla dott.ssa Elena Giovani, dirigente farmacista di II fascia dei ruoli dell’Agenzia italiana del farmaco.

Published: Mar 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ordine del giorno riunione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 17-18-19-20-21 marzo 2025.

Published: Mar 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 14/03/2025.

Published: Mar 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro EBVALLO

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 14/03/2025 è possibile utilizzare il medicinale EBVALLO, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Mar 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Procedura di applicazione Managed Entry Agreement - EBVALLO

Si informano gli utenti dei Registri di Monitoraggio AIFA che dal 14/03/2025 è attiva, sulla piattaforma dei Registri, la procedura telematica di applicazione dell’accordo di condivisione del rischio per il medicinale EBVALLO.

Published: Mar 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Comunicazione AIFA su Barbesaclone 100 mg

Nuove e importanti informazioni relative alla produzione e alla distribuzione del medicinale a denominazione generica Barbesaclone 100mg compresse rivestite - PROROGA SCADENZA.

Published: Mar 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Unregulated advanced therapy medicinal products pose serious risks to health

EMA and the Heads of Medicines Agencies (HMA) are warning the public about the dangers of unregulated advanced therapy medicinal products (ATMPs) offered to patients in the European Union.

Published: Mar 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

CCNCE: Webinar su Dichiarazione di Helsinki

Il CCNCE rende disponibili le presentazioni del Webinar sulla Dichiarazione di Helsinki, che si è svolto il 6 marzo 2025 in presenza del Segretario Nazionale della World Medical Association, Otmar Kloiber.

Published: Mar 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA public consultation on criteria for the attribution of therapeutic innovativeness

The Italian Medicines Agency is launching a public consultation on the document ‘Evaluation criteria for the attribution of therapeutic innovativeness and on the management of anti-infective agents for multi-drug resistant infections’.

Published: Mar 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

AIFA public consultation on criteria for attribution of therapeutic innovativeness

The deadline for submission is 18:00 on 22 March 2025.

Published: Mar 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Hepatitis C: update of 10 March 2025 concerning enrolled patients

AIFA has published the updated weekly data concerning treatments with new second-generation direct acting antiviral agents (DAAs) for chronic hepatitis C, as collected by AIFA Monitoring registries.

Published: Mar 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 07/03/2025.

Published: Mar 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

EMA procurement procedure for research projects on quality, safety, and efficacy of medicines

EMA is launching an open procurement procedure for all organisations capable of performing high-impact research on quality, safety, and efficacy of medicines to promote human and animal health in the EU.

Published: Mar 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Piano triennale per prevenzione della corruzione e della trasparenza - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Piano triennale per prevenzione della corruzione e della trasparenza".

Published: Mar 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Piano e Relazione sulla performance - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Piano e Relazione sulla performance".

Published: Mar 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Prevenzione della Corruzione - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Prevenzione della Corruzione".

Published: Mar 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Mar 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Il CdA AIFA approva la rimborsabilità di 8 farmaci

Sarà rimborsabile il farmaco per la progeria, la malattia rara di cui era affetto Sammy Basso.

Published: Mar 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Ordine del giorno riunione straordinaria Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione straordinaria della Commissione Scientifica e Economica (CSE) del 6 marzo 2025.

Published: Mar 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Innovative medicines list: AIFA publishes February 2025 update

AIFA updates the list of medicines that, in the opinion of the Scientific and Economic Committee for Medicines (CSE), meet the requirement of full or conditional therapeutic innovativeness.

Published: Mar 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Procedura di applicazione Managed Entry Agreement - PLUVICTO

Si informano gli utenti dei Registri di Monitoraggio AIFA che dal 04/03/2025 è attiva, sulla piattaforma dei Registri, la procedura telematica di applicazione dell’accordo di condivisione del rischio per il medicinale PLUVICTO.

Published: Mar 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro PLUVICTO

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 04/03/2025, è possibile utilizzare il medicinale PLUVICTO, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Mar 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Modifica Registro TRODELVY (TNBC)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che è stato aggiornato il Registro di Monitoraggio di Trodelvy dedicato al monitoraggio di una specifica indicazione terapeutica.

Published: Mar 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro KEYTRUDA NEOADIUVANTE ADIUVANTE (NSCLC)

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 04/03/2025 è possibile utilizzare il medicinale KEYTRUDA, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Mar 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro KEYTRUDA ADIUVANTE (RCC)

Published: Mar 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro TRODELVY (Carcinoma mammario HR+/HER2-)

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 04/03/2025, è possibile utilizzare il medicinale TRODELVY, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Mar 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro KEYTRUDA ADIUVANTE (BTC)

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 04/03/2025 è possibile utilizzare il medicinale KEYTRUDA, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Mar 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro KEYTRUDA HER2+

Published: Mar 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Hepatitis C: update of 3 March 2025 concerning enrolled patients

AIFA has published the updated weekly data concerning treatments with new second-generation direct acting antiviral agents (DAAs) for chronic hepatitis C, as collected by AIFA Monitoring registries.

Published: Mar 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

List of class A and H medicinal products at 16 September 2024

AIFA makes available, to healthcare professionals, a list of class A and H medicinal products dispensed by the National Health Service, sorted by active ingredient and trade name.

Published: Mar 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Self-certification and 7% contribution

Please note that all pharmaceutical companies must provide their self-certification to the Italian Medicines Agency (AIFA) no later than 30 April 2025.

Published: Mar 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Mar 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi politici, di amministrazione, di direzione o di governo - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Published: Mar 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

An AIFA “traffic-light” app to promote the appropriate use of antibiotics

It is a simple and flexible consultation tool, available to doctors as a support in antibiotic prescription, but also available to citizens.

Published: Mar 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

2025 AIFA Report on Antibiotics

Rising consumption and misuse push up bacterial resistance to antibiotics.

Published: Mar 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Modifica Registri KEYTRUDA (RCC)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, sono stati aggiornati i Registri di Monitoraggio di Keytruda dedicati al monitoraggio di due indicazioni terapeutiche.

Published: Mar 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Modifica Registri OPDIVO (RCC)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, sono stati aggiornati i Registri di Monitoraggio di Opdivo dedicati al monitoraggio di tre indicazioni terapeutiche.

Published: Mar 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Posti di funzione disponibili - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

Published: Mar 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento di posti di funzione dirigenziale di livello non generale. Rinnovo degli incarichi di direzione di: AAM - AVPM - AISP - ISF - IS - GVP

Rinnovo degli incarichi di direzione di: AAM - AVPM - AISP - ISF - IS - GVP.

Published: Mar 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Avviso per il conferimento del posto di funzione dirigenziale di livello non generale - Ufficio Sperimentazione Clinica e Ufficio Farmacovigilanza

Si procede alla pubblicità delle posizioni per il conferimento degli incarichi dirigenziali di livello non generale di direzione dell’Ufficio Sperimentazione Clinica e dell’Ufficio di Farmacovigilanza.

Published: Mar 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Esiti runione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile gli esiti dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 17-18-19-20-21 febbraio 2025.

Published: Feb 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Hepatitis C: update of 24 February 2025 concerning enrolled patients

L'Agenzia Italiana del Farmaco rende disponibile l’aggiornamento settimanale dei dati relativi ai trattamenti con i nuovi farmaci ad azione antivirale diretta di seconda generazione (DAAs) per la cura dell’epatite C cronica, raccolti dai Registri di monitoraggio AIFA.

Published: Feb 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Paolo Foggi confermato Chair dello Scientific Advice Working Party dell’EMA

Il Presidente Nisticò: “Importante riconoscimento alla professionalità dell’Agenzia, presente in ruoli chiave nella scena regolatoria europea”.

Published: Feb 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 28/02/2025.

Published: Feb 28, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Save the date - Rapporto sull’uso degli antibiotici in Italia

Interverranno: Robert Nisticò (Presidente AIFA), Pierluigi Russo (Direttore Tecnico-Scientifico AIFA), Maria Rosaria Campitiello (Capo Dipartimento della prevenzione, della ricerca e delle emergenze sanitarie del Ministero della Salute) e Massimo Andreoni (Direttore scientifico SIMIT).

Published: Feb 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA pubblica i Rapporti regionali 2023 sull'uso dei farmaci

Rapporti regionali sul consumo dei farmaci, un'analisi approfondita a livello territoriale in Italia.

Published: Feb 27, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Accesso civico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Accesso civico".

Published: Feb 25, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Farmaci per il trattamento del diabete mellito tipo 2: rimborsabilità del nuovo principio attivo tirzepatide

Rimborsato per il trattamento del diabete mellito tipo 2 nell’adulto il medicinale MOUNJARO (tirzepatide), first in class dei doppi agonisti recettoriali GIP/GLP-1.

Published: Feb 24, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 21/02/2025.

Published: Feb 21, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Feb 21, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Biosimilar medicines in Italy: AIFA reports updated

The analyses of consumption and expenditure trends and regional variability are online.

Published: Feb 21, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Atti amministrativi generali - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Atti amministrativi generali".

Published: Feb 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Feb 20, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Feb 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Audizione in Commissione Scientifica ed Economica del 18/02/2025

La Commissione Scientifica ed Economica dell'AIFA ha udito, il 18 febbraio 2025, il Direttore generale dell’AISM e il coordinatore del gruppo sclerosi multipla della SIN.

Published: Feb 19, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ruolo dirigenti e Atti generali - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Ruolo dirigenti e Atti generali".

Published: Feb 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi politici, di amministrazione, di direzione o di governo - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Published: Feb 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA and the Malta Medicines Authority sign a memorandum of understanding

President Nisticò: ‘Pharmaceuticals is a strategic sector, let's face the challenges together’.

Published: Feb 18, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Attivazione web e pubblicazione schede di monitoraggio - Registro RUBRACA PRIMA LINEA

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 16/02/2025 è possibile utilizzare il medicinale RUBRACA, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Feb 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA updates the Transparency Lists

AIFA has published the updated Transparency Lists of generic medicines together with the related reference prices, updated at 17 February 2025.

Published: Feb 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Hepatitis C: update of 17 February 2025 concerning enrolled patients

Published: Feb 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Feb 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Autorizzazione Convegni e Congressi - chiarimenti su "Consuntivazione eventi conclusi"

AIFA precisa che la comunicazione del 13 febbraio 2025, sulla consuntivazione degli eventi conclusi, fa riferimento a tutti gli eventi per i quali corre l’obbligo di inserire il consuntivo analitico delle spese. Per quelli ancora in ancora in corso o per i quali la data di fine è inferiore ai termini previsti dalla FAQ 28, saranno fornite ulteriori indicazioni sulla modalità di comunicazione del consuntivo dopo la dismissione dell'applicativo ACC.

Published: Feb 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA President, Robert Nisticò: ‘With Interceptor, an important step forward towards increasingly targeted and effective therapies’

Results of the study on biomarkers to predict Alzheimer's disease presented at ISS.

Published: Feb 17, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Ordine del giorno riunione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 17-18-19-20-21 febbraio 2025.

Published: Feb 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 14/02/2025.

Published: Feb 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

List of class A and H medicinal products at 1 August 2024

AIFA makes available, to healthcare professionals, a list of class A and H medicinal products dispensed by the National Health Service, sorted by active ingredient and trade name.

Published: Feb 14, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Italian Medicines Agency's online services will be unavailable due to scheduled maintenance

We inform users that AIFA's online services will be unavailable from Thursday, February 20, 2025, at 8:00 PM until Monday, February 24, 2025, at 8:00 AM.

Published: Feb 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro LYNPARZA (mCRPC)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, partire dal 13/02/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale LYPARZA per una specifica indicazione terapeutica.

Published: Feb 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro EVRYSDI

Si informano gli utenti dei Registri Farmaci sottoposti a Monitoraggio che, a partire dal 13/02/2025 è possibile utilizzare il medicinale EVRYSDI, in regime di rimborsabilità SSN, per una specifica indicazione terapeutica.

Published: Feb 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio EPCLUSA (HCV) - Registro semplificato

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 13/02/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale EPCLUSA per una specifica indicazione rimborsata.

Published: Feb 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Chiusura Managed Entry Agreements (MEA) Registro EPCLUSA

Si informano gli utenti dei Registri dei Farmaci sottoposti a monitoraggio che, a partire dal 13/02/2025, le procedure di applicazione degli accordi di condivisione del rischio, ovvero i Managed Entry Agreements (MEA), non sono più attive per il registro EPCLUSA per una specifica indicazione terapeutica.

Published: Feb 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA Board of Directors approves the reimbursability of 6 medicines

At its meeting on 12 February 2025, the Board of Directors of the Italian Medicines Agency (AIFA) approved the reimbursability by the National Health Service of 6 medicines including orphan drugs for rare diseases (1), generic medicines (3) and extensions of therapeutic indications (2).

Published: Feb 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Feb 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Autorizzazione Convegni e Congressi - Consuntivazione eventi conclusi

Si informano tutte Aziende farmaceutiche che, in vista della dismissione dell’applicativo Autorizzazione Convegni e Congressi nella versione precedente all'avvio esercizio della nuova piattaforma, è necessario provvedere entro il 20/02/2025 all'inserimento del consuntivo analitico delle spese all'interno delle pratiche per tutti gli eventi conclusi.

Published: Feb 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Ripiano della spesa farmaceutica per acquisti diretti per l’anno 2023

L’Agenzia Italiana del Farmaco (AIFA) ha adottato la Determina n. 205/2025 concernente l’attribuzione delle singole quote di ripiano della spesa farmaceutica per acquisti diretti per l’anno 2023.

Published: Feb 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Monitoring of Pharmaceutical expenditure (January / October 2024)

AIFA has published the documents relating to the monthly monitoring of national and regional pharmaceutical expenditure for the periods January / October 2024.

Published: Feb 13, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Biosimilar medicines in Italy: AIFA reports updated

The analyses of consumption and expenditure trends and regional variability are online.

Published: Feb 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi politici, di amministrazione, di direzione o di governo - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Published: Feb 12, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Feb 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Feb 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Hepatitis C: update of 10 February 2025 concerning enrolled patients

Published: Feb 11, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti dirigenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti dirigenti".

Published: Feb 10, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

List of class A and H medicinal products at 15 July 2024

AIFA makes available, to healthcare professionals, a list of class A and H medicinal products dispensed by the National Health Service, sorted by active ingredient and trade name.

Published: Feb 10, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Procedura di applicazione Managed Entry Agreement - LOARGYS

Si informano gli utenti dei Registri di Monitoraggio AIFA che dal 08/02/2025 è attiva, sulla piattaforma dei Registri, la procedura telematica di applicazione dell’accordo di condivisione del rischio per il medicinale LOARGYS.

Published: Feb 10, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro LOARGYS

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 08/02/2025, è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale LOARGYS per una specifica indicazione terapeutica.

Published: Feb 10, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Verifica dei dati trasmessi alla banca dati per la tracciabilità del farmaco relativi all’anno 2024

Si avvisano tutti i titolari AIC che  è consentito loro l'accesso completo alla banca dati centrale del farmaco per la tracciabilità al fine di verificare i dati relativi alle forniture a carico del Servizio Sanitario Nazionale comprensive dell'indicazione del mittente e del destinatario.

Published: Feb 10, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 07/02/2025.

Published: Feb 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

Published: Feb 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Feb 7, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Titolari di incarichi politici, di amministrazione, di direzione o di governo - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Published: Feb 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Feb 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Comunicazione alle Regioni su accesso ai fondi per i farmaci innovativi

Le dispensazioni inserite nella piattaforma dei Registri di monitoraggio AIFA rappresentano la fonte in base alla quale viene definita la ripartizione regionale delle risorse del fondo.

Published: Feb 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Pubblicazione dei provvedimenti di classificazione e rimborsabilità su TrovaNormeFarmaco

L'efficacia decorrerà dal giorno successivo alla pubblicazione dell'avviso sulla Gazzetta Ufficiale.

Published: Feb 6, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Qinlock® (ripretinib). Disponibile il report tecnico scientifico

L’Agenzia Italiana del Farmaco rende disponibile un report tecnico-scientifico sul medicinale Qinlock® (ripretinib).

Published: Feb 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Innovative medicines list: AIFA publishes January 2025 update

AIFA updates the list of medicines that, in the opinion of the Scientific and Economic Committee for Medicines (CSE), meet the requirement of full or conditional therapeutic innovativeness.

Published: Feb 5, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Aggiornamento elenchi medicinali omeopatici al 31 dicembre 2024

Aggiornamento degli elenchi dei medicinali omeopatici autorizzati alla commercializzazione sul territorio italiano, alla data del 31 dicembre 2024, con riferimento ai prodotti che ricadono nella disciplina della Legge 190/2014.

Published: Feb 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti dirigenti - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti dirigenti".

Published: Feb 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Monitoring of Pharmaceutical expenditure - January / September 2024

AIFA has published the documents relating to the monthly monitoring of national and regional pharmaceutical expenditure for the periods January / September 2024.

Published: Feb 4, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Hepatitis C: update of 3 February 2025 concerning enrolled patients

AIFA has published the updated weekly data concerning treatments with new second-generation direct acting antiviral agents (DAAs) for chronic hepatitis C, as collected by AIFA Monitoring registries.

Published: Feb 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Dirigenti II Fascia - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Dirigenti II Fascia".

Published: Feb 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA Ascolta, a direct line with patient associations

The new project of the Italian Medicines Agency.

Published: Feb 3, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

Aggiornamento "Diario di bordo sulla Trasparenza"

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 31/01/2025.

Published: Jan 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro TIBSOVO (LMA)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 31/01/2025 è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale TIBSOVO per una specifica indicazione terapeutica.

Published: Jan 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Attivazione web e pubblicazione schede di monitoraggio - Registro TIBSOVO (CCA)

Si informano gli utenti dei Registri dei Farmaci sottoposti a Monitoraggio che, a partire dal 31/01/2025, è possibile utilizzare, in regime di rimborsabilità SSN, il medicinale TIBSOVO per una specifica indicazione terapeutica.

Published: Jan 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Piano e Relazione sulla performance - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Piano e Relazione sulla performance".

Published: Jan 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Piano triennale per prevenzione della corruzione e della trasparenza - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Piano triennale per prevenzione della corruzione e della trasparenza".

Published: Jan 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Prevenzione della Corruzione - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Prevenzione della Corruzione".

Published: Jan 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Atti degli Organismi indipendenti di valutazione - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Atti degli Organismi indipendenti di valutazione".

Published: Jan 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Jan 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Sistema misurazione valutazione Performance - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Sistema misurazione valutazione Performance".

Published: Jan 31, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

Provvedimenti organi indirizzo-politico - aggiornamento sezione

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Published: Jan 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy NEWS

AIFA, the times of the procedures for admission to reimbursement of medicines are shortened

AIFA monitoring shows that in just under a year, the time for submitting and approving dossiers has been significantly reduced.

Published: Jan 30, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

AIFA Board of Directors approves the reimbursability of 13 medicines

The Board of Directors approved the admission to reimbursement by the NHS of 13 medicines, including orphan drugs for rare diseases (1), new medicines of chemical origin (3), generic medicines (2), extensions of therapeutic indications (6 medicine for 12 new therapeutic indications) and biosimilars (1).

Published: Jan 29, 2025 | Category: AIFA-Italy | Name: AIFA-Italy Press Releases

[SONOTA]Recent Publications by PMDA Staff updated

Published: Feb 20, 2025 | Category: PMDA | Name: PMDA Top News

[SHINSA]English translation of review report: HemeSight Analysis Program

Published: Feb 19, 2025 | Category: PMDA | Name: PMDA Top News

[IBENTO][IBENTO]PMDA-ATC Pediatric Review Seminar 2025

Published: Feb 19, 2025 | Category: PMDA | Name: PMDA Top News

[SHINSA]Consideration in the development of drugs for pulmonary arterial hypertension (Early Consideration) posted

Published: Feb 17, 2025 | Category: PMDA | Name: PMDA Top News

[SHINSA]Consideration in the development of drugs for pulmonary arterial hypertension (Early Consideration) posted

Published: Feb 17, 2025 | Category: PMDA | Name: PMDA Top News

[SHINSA]English Translation of Review Report: Vyvgart (Partial Change Approval)

Published: Feb 14, 2025 | Category: PMDA | Name: PMDA Top News

[SHINSA]Information on biosimilars is updated

Published: Feb 14, 2025 | Category: PMDA | Name: PMDA Top News

[ANZEN]PMDA Risk Communication: Axicabtagene ciloleucel, etc. posted

Published: Feb 7, 2025 | Category: PMDA | Name: PMDA Top News

[ANZEN]PMDA Risk Communication: Desmopressin acetate hydrate, etc. posted

Published: Feb 7, 2025 | Category: PMDA | Name: PMDA Top News

[SHINSA]GMP / GCTP Annual Report FY 2023 posted

Published: Feb 7, 2025 | Category: PMDA | Name: PMDA Top News

[ANZEN]PMDA Medical Safety Information: Cases of Air Embolism Due to the Use of Central Venous Catheters (No. 71) posted

Published: Feb 5, 2025 | Category: PMDA | Name: PMDA Top News

[KOKUSAI]PMDA Updates (January 2025 posted

Published: Jan 30, 2025 | Category: PMDA | Name: PMDA Top News

[ANZEN]Revisions of PRECAUTIONS: Ethical combination drugs (Brand name: Twinpal Injection), etc. posted

Published: Jan 29, 2025 | Category: PMDA | Name: PMDA Top News

[IBENTO][IBENTO]PMDA-ATC Medical Devices Webinar 2025 for AMDC

Published: Jan 29, 2025 | Category: PMDA | Name: PMDA Top News

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FDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses

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FDA Proposes Rule to Modernize Drug Manufacturing Registration

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