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Mantapath Consulting

Revolutionizing Regulatory Consultancy

Innovative strategies to transform your drug development paradigm

Mantapath Consulting
FDA Public Meeting: FDA-Led Patient-Focused Drug Development Meeting for Nonhealing Chronic Wounds
Aug 25, 2026
šŸŸ¢ Upcoming (37 days)
Meeting
July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee
Jul 23, 2026 ā€“ Jul 24, 2026
šŸŸ¢ Upcoming (4 days)
Advisory Committee Meeting
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments
Jun 23, 2026
šŸ”“ Past
Meeting
Advancing Generic Drug Development: Bioequivalence Challenges for Patient-Centric Oral Formulations
Jun 11, 2026
šŸ”“ Past
Webcast
Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop
Jun 8, 2026 ā€“ Jun 9, 2026
šŸ”“ Past
Workshop
FDA/MHRA/Health Canada Symposium: Regulatory perspectives in good clinical practice, bioequivalence and good pharmacovigilance practice
Jun 2, 2026 ā€“ Jun 4, 2026
šŸ”“ Past
Workshop
Eco-NAMs Webinar Series | In Silico Approaches to Replace Acute Fish Toxicity
May 28, 2026
šŸ”“ Past
Webcast
Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
May 19, 2026 ā€“ May 20, 2026
šŸ”“ Past
Conference
Advancing Novel Surrogate Endpoints For Rare Disease Drug Development Workshop
May 18, 2026
šŸ”“ Past
Public
Optimizing Pregnancy Registries Public Workshop
May 7, 2026 ā€“ May 8, 2026
šŸ”“ Past
Public
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
May 5, 2026 ā€“ May 6, 2026
šŸ”“ Past
Workshop
OTC Monograph Drug User Fee Amendments (OMUFA): Understanding FY 2026 User Fees and Registration
May 5, 2026
šŸ”“ Past
Webcast
April 30, 2026: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
Apr 30, 2026
šŸ”“ Past
Advisory Committee Meeting
FDA Webinar on the RCT-DUPLICATE Initiative: Emulating Randomized Clinical Trials with Non-Randomized Real-World Data Studies
Apr 29, 2026
šŸ”“ Past
Webcast
FDA Public Meeting on Increasing Access to Nonprescription Drugs
Apr 23, 2026
šŸ”“ Past
Meeting
Generic Drugs Forum (GDF) 2026
Apr 22, 2026 ā€“ Apr 23, 2026
šŸ”“ Past
Forum
Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers
Apr 15, 2026
šŸ”“ Past
Webcast
Eco-NAMs Webinar Series | Gill Cell-Line Assay for Acute Fish Toxicity Prediction
Jan 28, 2026
šŸ”“ Past
Webcast
FDA Information Session on Generic Drug Research Needs & Opportunities for FY 2026
Jan 21, 2026
šŸ”“ Past
Virtual
Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine
Dec 16, 2025
šŸ”“ Past
Workshop
Quality and Regulatory Predictability: Shaping USP Standards
Dec 11, 2025
šŸ”“ Past
Workshop
Pediatric Developmental Safety Assessment: New Approach Methods
Dec 5, 2025
šŸ”“ Past
Workshop
Public Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA)
Dec 3, 2025
šŸ”“ Past
Meeting
17th Annual Sentinel Initiative Public Workshop
Nov 6, 2025
šŸ”“ Past
Public
POSTPONED - 17th Annual Sentinel Initiative Public Workshop
Nov 6, 2025
šŸ”“ Past
Public
CANCELED - 17th Annual Sentinel Initiative Public Workshop
Nov 6, 2025
šŸ”“ Past
Public
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
Oct 15, 2025 ā€“ Oct 16, 2025
šŸ”“ Past
Workshop
Advancing Generic Drug Development: Translating Science to Approval 2025
Oct 7, 2025 ā€“ Oct 8, 2025
šŸ”“ Past
Workshop
FDA Public Meeting: Onshoring Manufacturing of Drugs and Biological Products
Sep 30, 2025
šŸ”“ Past
Meeting
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments
Sep 30, 2025
šŸ”“ Past
Meeting
Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment Public Meeting
Sep 24, 2025
šŸ”“ Past
Meeting
FDA/Center for Research on Complex Generics (CRCG) Workshop on Mastering Particle Size Analysis: A Step-By-Step Illustration of Techniques and Best Practices
Sep 23, 2025 ā€“ Sep 24, 2025
šŸ”“ Past
Workshop
FDA Public Workshop: Future Needs for the Development of Interchangeable Products
Sep 19, 2025
šŸ”“ Past
Workshop
Patient-Focused Drug Development: Workshop #2 to Discuss Methodologic and Other Challenges Related to Patient Experience Data
Sep 18, 2025 ā€“ Sep 19, 2025
šŸ”“ Past
Workshop
FDA Public Meeting: BsUFA III Regulatory Science Program Interim Public Meeting
Sep 18, 2025
šŸ”“ Past
Meeting
Assessing Novel Efficacy Endpoints in Ophthalmologic Rare Disease Drug and Biologics Development
Sep 17, 2025
šŸ”“ Past
Workshop
ICH M13B Webinar: Navigating the Draft ICH M13B Additional Strengths Biowaiver Guideline
Sep 11, 2025
šŸ”“ Past
Virtual
FDAā€™s Sixth Online Controlled Substances Summit
Sep 11, 2025
šŸ”“ Past
Meeting
Eco-NAMs Webinar Series | State of the Science for Bioaccumulation: An Integrated, Weight of Evidence Approach
Sep 10, 2025
šŸ”“ Past
Virtual
Lessons Learned From the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program
Sep 10, 2025
šŸ”“ Past
Workshop
Compounding Quality Center of Excellence | Annual Conference
Aug 25, 2025 ā€“ Aug 28, 2025
šŸ”“ Past
Conference
Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population
Jul 23, 2025
šŸ”“ Past
Meeting
July 18, 2025: Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement
Jul 18, 2025
šŸ”“ Past
Advisory Committee Meeting
July 17, 2025: Meeting of the Oncologic Drugs Advisory Committee
Jul 17, 2025
šŸ”“ Past
Advisory Committee Meeting
Public Meeting on the Reauthorization of the Prescription Drug User Fee Act (PDUFA)
Jul 14, 2025
šŸ”“ Past
Meeting
Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA)
Jul 11, 2025
šŸ”“ Past
Public
Fiscal Year 2025 Generic Drug Science and Research Initiatives Public Workshop
Jun 3, 2025 ā€“ Jun 4, 2025
šŸ”“ Past
Workshop
Primary Mitochondrial Diseases Virtual Public Workshop
May 22, 2025
šŸ”“ Past
Workshop
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration
May 20, 2025
šŸ”“ Past
Virtual
FDA CDER Overview: Certificates of Confidentiality
May 7, 2025
šŸ”“ Past
Virtual
CDER Bioresearch Monitoring: Electronic Submission Requirements for New Drug and Biologic Licensing Applications
May 6, 2025
šŸ”“ Past
Virtual
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
May 5, 2025
šŸ”“ Past
Advisory Committee Meeting
Implementing FDAā€™s IVPT Guidance Recommendations: A Step-By-Step Illustration
Apr 29, 2025 ā€“ Apr 30, 2025
šŸ”“ Past
Workshop
Generic Drugs Forum (GDF) 2025
Apr 9, 2025 ā€“ Apr 10, 2025
šŸ”“ Past
Forum
Optimizing Pregnancy Registries
Mar 27, 2025 ā€“ Mar 28, 2025
šŸ”“ Past
Public
POSTPONED - Optimizing Pregnancy Registries
Mar 27, 2025 ā€“ Mar 28, 2025
šŸ”“ Past
Public
FDA/PQRI Workshop: ANDA Quality with CDERā€™s Office of Pharmaceutical Quality
Mar 20, 2025 ā€“ Mar 21, 2025
šŸ”“ Past
Workshop
Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions
Mar 13, 2025
šŸ”“ Past
Virtual
Navigating Controlled Correspondences to Support Generic Drug Development
Feb 27, 2025
šŸ”“ Past
Virtual
February 24, 2025 Meeting of the Cardiovascular and Renal Drugs Advisory Committee
Feb 24, 2025
šŸ”“ Past
Advisory Committee Meeting
BsUFA III Regulatory Science Pilot Program: Progress Update
Jan 22, 2025
šŸ”“ Past
Virtual
UPDATED PUBLIC PARTICIPATION INFORMATION: January 10, 2025: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement
Jan 10, 2025
šŸ”“ Past
Advisory Committee Meeting
Patient-Focused Drug Development: Workshop to Discuss Methodologic and Other Challenges Related to Patient Experience Data
Dec 13, 2024
šŸ”“ Past
Virtual
Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products
Dec 12, 2024
šŸ”“ Past
Public
FDA Clinical Investigator Training Course (CITC) 2024
Dec 10, 2024 ā€“ Dec 12, 2024
šŸ”“ Past
Conference
UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee
Dec 4, 2024
šŸ”“ Past
Advisory Committee Meeting
Navigating the Transition to Low Global Warming Potential Propellants
Dec 4, 2024 ā€“ Dec 5, 2024
šŸ”“ Past
Workshop
Clinical Pharmacology Considerations for Novel Therapeutic Modalities
Dec 4, 2024
šŸ”“ Past
Virtual
M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms - Implementing the Final Guidance
Nov 21, 2024
šŸ”“ Past
Virtual
Public Meeting on the Recommendations for the Over-the-Counter Monograph Drug User Fee Program (OMUFA) Reauthorization - 11/20/2024
Nov 20, 2024
šŸ”“ Past
Meeting
UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: November 19, 2024: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Psychopharmacologic Drugs Advisory Committee Meeting Announcement
Nov 19, 2024
šŸ”“ Past
Advisory Committee Meeting
Nonprescription Analgesic/Antipyretic Drug Development in Children 2 to Less Than 12 Years of Age
Nov 15, 2024
šŸ”“ Past
Public
Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies
Nov 12, 2024
šŸ”“ Past
Virtual
16th Annual Sentinel Initiative Public Workshop
Nov 7, 2024
šŸ”“ Past
Public
Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation
Nov 7, 2024
šŸ”“ Past
Virtual
Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities and Bioequivalence Assessment for Reformulated Drug Products
Nov 6, 2024 ā€“ Nov 7, 2024
šŸ”“ Past
Workshop
2024 Scientific Computing and Digital Transformation Symposium
Nov 4, 2024 ā€“ Nov 6, 2024
šŸ”“ Past
Conference
UPDATED MEETING TIME INFORMATION: October 31, 2024: Meeting of Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
Oct 31, 2024
šŸ”“ Past
Advisory Committee Meeting
October 29, 2024: Meeting of the Pharmacy Compounding Advisory Committee
Oct 29, 2024
šŸ”“ Past
Advisory Committee Meeting
Opportunities to Improve Dose-Finding and Optimization for Rare Disease Drug Development
Oct 29, 2024
šŸ”“ Past
Workshop
2024 DIA/FDA Oligonucleotide-Based Therapeutics Conference
Oct 28, 2024 ā€“ Oct 30, 2024
šŸ”“ Past
Conference
Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub
Oct 16, 2024
šŸ”“ Past
Meeting
Global IDMP Implementation - Getting Closer to the Goal
Oct 16, 2024
šŸ”“ Past
Virtual
FDA-CDER and HESI | Nitrosamine Ames Data Review and Method Development Workshop
Oct 15, 2024 ā€“ Oct 16, 2024
šŸ”“ Past
Meeting
October 10, 2024: Meeting of the Cardiovascular and Renal Drugs Advisory Committee
Oct 10, 2024
šŸ”“ Past
Advisory Committee Meeting
ICH M12 Drug-Drug Interaction Studies Final Guidance
Oct 9, 2024
šŸ”“ Past
Virtual
Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products
Oct 7, 2024 ā€“ Oct 8, 2024
šŸ”“ Past
Public
Proteinuria and GFR as Clinical Trial Endpoints in Focal Segmental Glomerulosclerosis: A Scientific Workshop
Oct 7, 2024 ā€“ Oct 8, 2024
šŸ”“ Past
Workshop
Guidance Development and Regulatory Assessment of Generic Topical and Dermal Drug Products
Oct 3, 2024
šŸ”“ Past
Workshop
September 26, 2024: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
Sep 26, 2024
šŸ”“ Past
Advisory Committee Meeting
Advancing Generic Drug Development: Translating Science to Approval 2024
Sep 24, 2024 ā€“ Sep 25, 2024
šŸ”“ Past
Workshop
UPDATED AGENDA INFORMATION: September 13, 2024: Meeting of the Gastrointestinal Drugs Advisory Committee Meeting Announcement
Sep 13, 2024
šŸ”“ Past
Advisory Committee Meeting
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024
Sep 12, 2024
šŸ”“ Past
Conference
ANDA Submissions ā€“ Amendments to Abbreviated New Drug Applications under GDUFA
Sep 10, 2024
šŸ”“ Past
Virtual
2024 PDA/ FDA Joint Regulatory Conference
Sep 9, 2024 ā€“ Sep 11, 2024
šŸ”“ Past
Conference
September 9, 2024: Meeting of the Antimicrobial Drugs Advisory Committee Meeting Announcement
Sep 9, 2024
šŸ”“ Past
Advisory Committee Meeting
ADEPT-9: Public Workshop on Enhancing Diversity in Therapeutics Development for Pediatric Patients
Sep 6, 2024
šŸ”“ Past
Public
Advancing Treatments for Post-Traumatic Stress Disorder (PTSD)
Sep 6, 2024
šŸ”“ Past
Meeting
FDA | NIH : Regulatory Doā€™s and Donā€™ts: Tips from FDA
Sep 4, 2024
šŸ”“ Past
Virtual
2024 Compounding Quality Center of Excellence Annual Conference
Aug 21, 2024 ā€“ Aug 23, 2024
šŸ”“ Past
Conference
Evaluating the Negative Symptoms of Schizophrenia in Clinical Trials
Aug 16, 2024
šŸ”“ Past
Meeting
Evaluating Excipient Safety in Pediatric Populations: Current Thinking from a Bioequivalence Perspective
Aug 8, 2024
šŸ”“ Past
Conference
UPDATED PUBLIC PARTICIPATION INFORMATION: August 2, 2024: Meeting of the Genetic Metabolic Diseases Advisory Committee Meeting Announcement
Aug 2, 2024
šŸ”“ Past
Advisory Committee Meeting
Environmental Monitoring in Compounding
Jul 30, 2024
šŸ”“ Past
Virtual
Dataset-JSON Pilot Report and Next Steps
Jul 25, 2024
šŸ”“ Past
Virtual
UPDATED AGENDA INFORMATION : July 25, 2024 Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
Jul 25, 2024
šŸ”“ Past
Advisory Committee Meeting
FDAā€™s Fifth Online Controlled Substances Summit
Jul 25, 2024 ā€“ Jul 26, 2024
šŸ”“ Past
Virtual
Introduction to FDAā€™s Office of Trade and Global Partnerships
Jul 23, 2024
šŸ”“ Past
Virtual
Public Workshop: Best Practices for Meeting Management Under PDUFA VII
Jul 22, 2024
šŸ”“ Past
Workshop
Office of Pharmaceutical Quality (OPQ) Reorganization
Jul 11, 2024
šŸ”“ Past
Virtual
Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products
Jul 11, 2024 ā€“ Jul 12, 2024
šŸ”“ Past
Public
Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest
Jun 27, 2024
šŸ”“ Past
Meeting
Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule
Jun 26, 2024
šŸ”“ Past
Virtual
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration
Jun 18, 2024
šŸ”“ Past
Virtual
Partnership for DSCSA Governance (PDG)/FDA Joint Public Meeting: DSCSA Stabilization Period Midway Checkpoint
Jun 17, 2024 ā€“ Jun 18, 2024
šŸ”“ Past
Conference
OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice
Jun 13, 2024
šŸ”“ Past
Workshop
UPDATED PUBLIC PARTICIPATION INFORMATION: June 10, 2024: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement
Jun 10, 2024
šŸ”“ Past
Advisory Committee Meeting
2024 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments
Jun 6, 2024
šŸ”“ Past
Meeting
UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: June 4, 2024: Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement
Jun 4, 2024
šŸ”“ Past
Advisory Committee Meeting
FDA/PHUSE Computational Science Symposium
Jun 3, 2024 ā€“ Jun 5, 2024
šŸ”“ Past
Workshop
Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development
May 29, 2024 ā€“ May 30, 2024
šŸ”“ Past
Conference
May 24, 2024 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
May 24, 2024
šŸ”“ Past
Advisory Committee Meeting
May 22, 2024: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting Announcement
May 22, 2024
šŸ”“ Past
Advisory Committee Meeting
Fiscal Year 2024 Generic Drug Science and Research Initiatives Public Workshop
May 20, 2024 ā€“ May 21, 2024
šŸ”“ Past
Workshop
Statistical Considerations for Premarketing Risk Assessment
May 16, 2024
šŸ”“ Past
Virtual
Natural History Studies and Registries in the Development of Rare Disease Treatments
May 13, 2024
šŸ”“ Past
Workshop
Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval
May 9, 2024
šŸ”“ Past
Virtual
Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment | Role and Opportunities
May 8, 2024 ā€“ May 9, 2024
šŸ”“ Past
Public
Drug Development Considerations for the Treatment of Neonatal Enterovirus Infection and Congenital Cytomegalovirus Infection--Virtual Public Workshop
May 7, 2024 ā€“ May 8, 2024
šŸ”“ Past
Public
FDA/CRCG Workshop: Considerations and Potential Regulatory Applications for a Model Master File
May 2, 2024 ā€“ May 3, 2024
šŸ”“ Past
Public
Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Psychopharmacologic Drugs Advisory Committee
Apr 25, 2024
šŸ”“ Past
Advisory Committee Meeting
Streamlining Drug Development and Improving Public Health through Quantitative Medicine: An Introduction to the CDER Quantitative Medicine Center of Excellence
Apr 25, 2024
šŸ”“ Past
Virtual
Facilitating Generic Drug Product Development through Product-Specific Guidances
Apr 25, 2024
šŸ”“ Past
Virtual
Drug Development Considerations for Empiric Antibacterial Therapy in Febrile Neutropenic Patients
Apr 23, 2024
šŸ”“ Past
Public
PQRI Workshop: Challenges and Opportunities for Modified Release Oral Drug Product Development
Apr 18, 2024
šŸ”“ Past
Workshop
PQRI/EUFEPS Global Bioequivalence Harmonisation Initiative (GBHI): 6th International Workshop
Apr 16, 2024 ā€“ Apr 17, 2024
šŸ”“ Past
Workshop
April 12, 2024 Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
Apr 12, 2024
šŸ”“ Past
Advisory Committee Meeting
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access
Apr 10, 2024 ā€“ Apr 11, 2024
šŸ”“ Past
Conference
Enhancing Adoption of Innovative Clinical Trial Approaches
Mar 19, 2024 ā€“ Mar 20, 2024
šŸ”“ Past
Public
March 15, 2024: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
Mar 15, 2024
šŸ”“ Past
Advisory Committee Meeting
March 14, 2024: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
Mar 14, 2024
šŸ”“ Past
Advisory Committee Meeting
Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes
Mar 7, 2024
šŸ”“ Past
Virtual
Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice
Mar 5, 2024
šŸ”“ Past
Workshop
UPDATED AGENDA INFORMATION: March 5, 2024: Meeting of the Medical Imaging Drugs Advisory Committee Meeting Announcement
Mar 5, 2024
šŸ”“ Past
Advisory Committee Meeting
Product Quality Research Institute (PQRI) Workshop: MIDD Approaches in Pediatric Formulation Development
Feb 28, 2024 ā€“ Feb 29, 2024
šŸ”“ Past
Public
Expanding Generic Drug Access Through International Engagements
Feb 28, 2024
šŸ”“ Past
Virtual
FDA/CDER and American Association of Pharmaceutical Scientists (AAPS) Hybrid Public Workshop
Feb 26, 2024
šŸ”“ Past
Public
Joint US FDA ā€“ Health Canada ICH Public Meeting
Feb 22, 2024
šŸ”“ Past
Virtual
FDA/CDER Office of Clinical Pharmacology and American Association for Cancer Research Public Workshop
Feb 15, 2024 ā€“ Feb 16, 2024
šŸ”“ Past
Public
A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium
Feb 13, 2024 ā€“ Feb 15, 2024
šŸ”“ Past
Symposium
Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches
Jan 31, 2024
šŸ”“ Past
Public
Public Workshop: Advancing Psychedelic Clinical Study Design
Jan 31, 2024 ā€“ Feb 1, 2024
šŸ”“ Past
Workshop
Advancing Drug Development for the Prevention of Spontaneous Preterm Birth
Jan 23, 2024 ā€“ Jan 24, 2024
šŸ”“ Past
Public
A Deep Dive: FDAā€™s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs
Jan 18, 2024
šŸ”“ Past
Virtual
Public Meeting on Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement
Dec 14, 2023
šŸ”“ Past
Virtual
Adult Attention-Deficit/Hyperactivity Disorder: Diagnosis, Treatment, and Implications for Drug Development Workshop
Dec 12, 2023 ā€“ Dec 13, 2023
šŸ”“ Past
Workshop
Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources
Dec 12, 2023 ā€“ Dec 13, 2023
šŸ”“ Past
Virtual
FDA Clinical Investigator Training Course (CITC) 2023
Dec 6, 2023 ā€“ Dec 7, 2023
šŸ”“ Past
Conference
Advancing the Development of Pediatric Therapeutics (ADEPT) 8 Workshop on Drug Dosing in Pediatric Patients with Renal Impairment
Nov 30, 2023 ā€“ Dec 1, 2023
šŸ”“ Past
Workshop
Discussing Approaches to Enhance Clinical Study Diversity Public Workshop
Nov 29, 2023 ā€“ Nov 30, 2023
šŸ”“ Past
Webcast
Toward Global IDMP Implementation: A Focus on Global Use Cases
Nov 28, 2023
šŸ”“ Past
Virtual
November 17, 2023: Meeting of the Pulmonary-Allergy Drugs Advisory Committee
Nov 17, 2023
šŸ”“ Past
Advisory Committee Meeting
November 16, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
Nov 16, 2023
šŸ”“ Past
Advisory Committee Meeting
Common Issues with SEND Data Submitted for Safety Pharmacology Studies
Nov 16, 2023
šŸ”“ Past
Virtual
Positron Emission Tomography: Product Quality Regulatory Submissions, Facility Inspections, and Benefit-Risk Considerations
Nov 13, 2023 ā€“ Nov 14, 2023
šŸ”“ Past
Public
FDA Office of Clinical Pharmacology and International Society of Pharmacometrics (ISoP) Public Workshop: Using Modeling and Simulation to Select Dosages for Combination Therapies and New Indications
Nov 9, 2023
šŸ”“ Past
Workshop
Endpoints and Trial Designs to Advance Drug Development in Kidney Transplantation
Nov 9, 2023
šŸ”“ Past
Public
Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing
Oct 31, 2023 ā€“ Nov 1, 2023
šŸ”“ Past
Symposium
Defining 'Candy-Like' Nonprescription Drug Products
Oct 30, 2023
šŸ”“ Past
Workshop
FDA/CTTI Meeting on Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies
Oct 18, 2023 ā€“ Oct 19, 2023
šŸ”“ Past
Public
FDA | CTTI Meeting on Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies
Oct 18, 2023 ā€“ Oct 19, 2023
šŸ”“ Past
Public
BsUFA III Regulatory Science Pilot Program
Oct 16, 2023
šŸ”“ Past
Virtual
FDA/CDER Office of Clinical Pharmacology and International Society of Pharmacometrics (ISoP) Public Workshop: Using Modeling and Simulation to Evaluate the Effects of Intrinsic and Extrinsic Factors
Oct 16, 2023
šŸ”“ Past
Workshop
Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development
Oct 12, 2023
šŸ”“ Past
Workshop
2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials
Oct 11, 2023
šŸ”“ Past
Symposium
October 5, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
Oct 5, 2023
šŸ”“ Past
Advisory Committee Meeting
Mitigating Risks from Human Xylazine Exposure
Oct 4, 2023
šŸ”“ Past
Public
October 4, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
Oct 4, 2023
šŸ”“ Past
Advisory Committee Meeting
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023
Sep 28, 2023
šŸ”“ Past
Conference
Public Meeting on the Reauthorization of the Over-the-Counter Monograph Drug User Fee Program (OMUFA) - 09/28/2023
Sep 28, 2023
šŸ”“ Past
Meeting
FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing
Sep 26, 2023 ā€“ Sep 27, 2023
šŸ”“ Past
Public
UPDATED PUBLIC PARTICIPATION INFORMATION: September 21, 2023 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
Sep 21, 2023
šŸ”“ Past
Advisory Committee Meeting
2023 PDA/ FDA Joint Regulatory Conference
Sep 18, 2023 ā€“ Sep 20, 2023
šŸ”“ Past
Conference
Use of Biomarkers for Diagnosing and Assessing Treatment Response in Noncirrhotic NASH Trials
Sep 18, 2023 ā€“ Sep 19, 2023
šŸ”“ Past
Conference
FDA/PHUSE Computational Science Symposium (CSS)
Sep 18, 2023 ā€“ Sep 20, 2023
šŸ”“ Past
Public
UPDATED PUBLIC PARTICIPATION INFORMATION: September 13, 2023: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
Sep 13, 2023
šŸ”“ Past
Advisory Committee Meeting
Advancing Generic Drug Development: Translating Science to Approval 2023
Sep 13, 2023 ā€“ Sep 14, 2023
šŸ”“ Past
Conference
Increasing the Efficiency of Biosimilar Development Programs - Reevaluating the Need for Comparative Clinical Efficacy Studies
Sep 12, 2023 ā€“ Sep 13, 2023
šŸ”“ Past
Virtual
2023 Scientific Computing Days
Sep 12, 2023 ā€“ Sep 13, 2023
šŸ”“ Past
Conference
UPDATED: September 11-12, 2023: Meeting of the Nonprescription Drugs Advisory Committee Meeting Announcement
Sep 11, 2023 ā€“ Sep 12, 2023
šŸ”“ Past
Advisory Committee Meeting
Compounding Quality Center of Excellence Annual Conference
Sep 11, 2023 ā€“ Sep 13, 2023
šŸ”“ Past
Conference
Understanding FDA Inspections and Data
Sep 6, 2023
šŸ”“ Past
Virtual
OTC Monograph Reform: OMOR Format and Content & Electronic Submissions
Aug 22, 2023
šŸ”“ Past
Virtual
August 1, 2023: Meeting of the Medical Imaging Drugs Advisory Committee Meeting Announcement
Aug 1, 2023
šŸ”“ Past
Advisory Committee Meeting
June 28, 2023 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
Jun 28, 2023
šŸ”“ Past
Advisory Committee Meeting
FDA WORKSHOP: 8th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop
Jun 27, 2023
šŸ”“ Past
Virtual
Decentralized Clinical Trials (DCT) Draft Guidance
Jun 20, 2023
šŸ”“ Past
Virtual
June 16, 2023: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting Announcement
Jun 16, 2023
šŸ”“ Past
Advisory Committee Meeting
Mitigation Strategies for Nitrosamine Drug Substance Related Impurities: Quality and Bioequivalence Considerations for Generic Products
Jun 15, 2023
šŸ”“ Past
Public
Overview: Clinical Pharmacology Considerations for Food Effect Studies
Jun 15, 2023
šŸ”“ Past
Virtual
UPDATED INFORMATION: June 9, 2023: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement
Jun 9, 2023
šŸ”“ Past
Advisory Committee Meeting
2023 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments
Jun 8, 2023
šŸ”“ Past
Meeting
June 8, 2023: Meeting of the Antimicrobial Drugs Advisory Committee Meeting Announcement
Jun 8, 2023
šŸ”“ Past
Advisory Committee Meeting
FDA CDER and CBER & Duke-Margolis Center for Health Policy | Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development
Jun 7, 2023 ā€“ Jun 8, 2023
šŸ”“ Past
Public
Regulatory Education for Industry (REdI) Annual Conference 2023
Jun 5, 2023 ā€“ Jun 9, 2023
šŸ”“ Past
Virtual
FDA/HESI Research Roadmap Planning on Hazard and Risk Assessment of Nitrosamine Impurities in Drugs
May 31, 2023 ā€“ Jun 1, 2023
šŸ”“ Past
Workshop
An Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)
May 24, 2023
šŸ”“ Past
Virtual
May 19, 2023: Meeting of the Gastrointestinal Drugs Advisory Committee Meeting Announcement
May 19, 2023
šŸ”“ Past
Advisory Committee Meeting
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration
May 16, 2023
šŸ”“ Past
Virtual
A Deep Dive: GDUFA III Scientific Meetings
May 15, 2023
šŸ”“ Past
Virtual
Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop
May 11, 2023 ā€“ May 12, 2023
šŸ”“ Past
Workshop
May 11, 2023: Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement
May 11, 2023
šŸ”“ Past
Advisory Committee Meeting
Creating a Roadmap to Quantitative Systems Pharmacology-Informed Rare Disease Drug Development
May 11, 2023
šŸ”“ Past
Virtual
FDA/CRCG Drug-Device Combination Products 101: Identifying, Developing, and Evaluating Drug-Device Combination Products
May 10, 2023
šŸ”“ Past
Public
Considerations for Buprenorphine Initiation and Maintenance Care
May 10, 2023 ā€“ May 11, 2023
šŸ”“ Past
Virtual
May 9-10, 2023: Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement
May 9, 2023 ā€“ May 10, 2023
šŸ”“ Past
Advisory Committee Meeting
Public Webinar Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making ā€“ Draft Guidance
May 4, 2023
šŸ”“ Past
Virtual
FDA CDER & JHU CERSI Workshop | Addressing Challenges in the Design and Analysis of Rare Disease Clinical Trials: Considerations and Tools
May 2, 2023 ā€“ May 3, 2023
šŸ”“ Past
Public
Navigating the First ICH Generic Drug Draft Guideline ā€œM13A Bioequivalence for Immediate-Release Solid Oral Dosage Formsā€
May 2, 2023
šŸ”“ Past
Virtual
April 28, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
Apr 28, 2023
šŸ”“ Past
Advisory Committee Meeting
FDA | United States Pharmacopeia (USP) Asia-Pacific Economic Cooperation (APEC) Medical Product Supply Chain Dialogue
Apr 25, 2023 ā€“ Apr 26, 2023
šŸ”“ Past
Workshop
ReuniĆ³n pĆŗblica sobre el desarrollo de medicamentos centrados en el paciente contra el COVID-19 persistente
Apr 25, 2023
šŸ”“ Past
Virtual
Public Meeting on Patient-Focused Drug Development for Long COVID
Apr 25, 2023
šŸ”“ Past
Virtual
Electronic Systems, Electronic Records, and Electronic Signatures Webinar
Apr 25, 2023
šŸ”“ Past
Virtual
FDA/CRCG Considerations for and Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Generic Orally Inhaled Drug Products
Apr 20, 2023 ā€“ Apr 21, 2023
šŸ”“ Past
Public
April 19, 2023: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement
Apr 19, 2023
šŸ”“ Past
Advisory Committee Meeting
FDAā€™s Dosage and Administration Section of Labeling Draft Guidance
Apr 19, 2023 ā€“ Apr 20, 2023
šŸ”“ Past
Virtual
UPDATED INFORMATION: April 17, 2023: Meeting of the Antimicrobial Drugs Advisory Committee Meeting Announcement
Apr 17, 2023
šŸ”“ Past
Advisory Committee Meeting
April 14, 2023: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement
Apr 14, 2023
šŸ”“ Past
Advisory Committee Meeting
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF
Apr 12, 2023 ā€“ Apr 13, 2023
šŸ”“ Past
Virtual
UPDATED INFORMATION: April 12, 2023: Meeting of the Nonprescription Drugs Advisory Committee Meeting Announcement
Apr 12, 2023
šŸ”“ Past
Advisory Committee Meeting
Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards
Apr 4, 2023 ā€“ Nov 7, 2023
šŸ”“ Past
Public
17th Annual FDA/DIA Biostatistics Industry and Regulator Forum, 2023
Mar 29, 2023 ā€“ Mar 31, 2023
šŸ”“ Past
Public
March 28-29, 2023: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee Meeting Announcement
Mar 28, 2023 ā€“ Mar 29, 2023
šŸ”“ Past
Advisory Committee Meeting
Public Workshop: Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review
Mar 28, 2023 ā€“ Mar 29, 2023
šŸ”“ Past
Public
March 28, 2023: Conversations on Cancer: ā€œAdvancing a More Equal Future for AA & NHPI Patients with Cancerā€
Mar 28, 2023
šŸ”“ Past
Virtual
UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: March 22, 2023: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement
Mar 22, 2023
šŸ”“ Past
Advisory Committee Meeting
CANCELLED: March 20, 2023: Joint Meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Announcement
Mar 20, 2023
šŸ”“ Past
Advisory Committee Meeting
UPDATED INFORMATION: March 16, 2023: Antimicrobial Drugs Advisory Committee Meeting Announcement
Mar 16, 2023
šŸ”“ Past
Advisory Committee Meeting
A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence
Mar 14, 2023
šŸ”“ Past
Virtual
March 9, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
Mar 9, 2023
šŸ”“ Past
Advisory Committee Meeting
Understanding Fatal Overdoses to Inform Product Development and Public Health Interventions to Manage Overdose
Mar 8, 2023 ā€“ Mar 9, 2023
šŸ”“ Past
Virtual
Joint US FDA ā€“ Health Canada ICH Public Meeting
Feb 24, 2023
šŸ”“ Past
Virtual
Application of Artificial Intelligence and Machine Learning for Precision Medicine
Feb 17, 2023
šŸ”“ Past
Virtual
February 15, 2023: Joint Meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement
Feb 15, 2023
šŸ”“ Past
Advisory Committee Meeting
Overview: Clinical Pharmacology Considerations for Neonatal Studies
Feb 15, 2023
šŸ”“ Past
Virtual
UPDATED INFORMATION: February 9, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
Feb 9, 2023
šŸ”“ Past
Advisory Committee Meeting
Overview of FDAā€™s Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use
Feb 1, 2023
šŸ”“ Past
Virtual
FDAā€™s Labeling Resources for Human Prescription Drugs
Jan 26, 2023
šŸ”“ Past
Virtual
UPDATED PUBLIC PARTICIPATION INFORMATION: January 24, 2023: Antimicrobial Drugs Advisory Committee Meeting Announcement
Jan 24, 2023
šŸ”“ Past
Advisory Committee Meeting
Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards
Jan 13, 2023
šŸ”“ Past
Virtual
January 9, 2023: Dermatologic and Ophthalmic Drugs Advisory Committee Meeting
Jan 9, 2023
šŸ”“ Past
Advisory Committee Meeting
Efficacy of Monoclonal Antibodies in the Context of Rapidly Evolving SARS-CoV-2 Variants
Dec 15, 2022
šŸ”“ Past
Virtual
UPDATED INFORMATION : December 14, 2022: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
Dec 14, 2022
šŸ”“ Past
Advisory Committee Meeting
What to Expect after an Inspection: 483s, Responses and Beyond
Dec 14, 2022
šŸ”“ Past
Virtual
December 13, 2022: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
Dec 13, 2022
šŸ”“ Past
Advisory Committee Meeting
The Drug Supply Chain Security Act (DSCSA) Implementation and Readiness Efforts for 2023
Dec 7, 2022 ā€“ Dec 8, 2022
šŸ”“ Past
Public
FDA Clinical Investigator Training Course (CITC) 2022
Dec 7, 2022 ā€“ Dec 8, 2022
šŸ”“ Past
Virtual
Excipients and Formulation Assessments of Complex Generic Products: Best Practices and Lessons Learned Webinar
Dec 6, 2022
šŸ”“ Past
Public
Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions
Nov 30, 2022
šŸ”“ Past
Conference
UPDATED INFORMATION : November 22, 2022: Meeting of the Oncologic Drugs Advisory Committee Announcement
Nov 22, 2022
šŸ”“ Past
Advisory Committee Meeting
POSTPONED: November 18, 2022 Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement
Nov 18, 2022
šŸ”“ Past
Advisory Committee Meeting
FDA-CDER-CDRH, SNMMI, and MITA Workshop: Quantitative Brain Amyloid PET Imaging-Technical Considerations
Nov 17, 2022
šŸ”“ Past
Public
Proposed Rule: Revising the National Drug Code Format and Drug Label Barcode Requirements
Nov 17, 2022
šŸ”“ Past
Virtual
November 16, 2022 Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
Nov 16, 2022
šŸ”“ Past
Advisory Committee Meeting
14th Annual Sentinel Initiative Public Workshop
Nov 15, 2022 ā€“ Nov 16, 2022
šŸ”“ Past
Workshop
FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement
Nov 14, 2022 ā€“ Nov 16, 2022
šŸ”“ Past
Virtual
Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches
Nov 9, 2022
šŸ”“ Past
Virtual
UPDATED AGENDA AND PUBLIC PARTICIPATION INFORMATION: November 9, 2022 Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement
Nov 9, 2022
šŸ”“ Past
Advisory Committee Meeting
FDA/IMS Joint Workshop: Future of Drug Development in Multiple Myeloma
Nov 8, 2022 ā€“ Nov 9, 2022
šŸ”“ Past
Public
Updated Information: November 8, 2022: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement
Nov 8, 2022
šŸ”“ Past
Advisory Committee Meeting
Formulation Characterization and Cutaneous Pharmacokinetics to Facilitate Generic Topical Product Development
Nov 3, 2022
šŸ”“ Past
Workshop
November 2-3, 2022: Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement
Nov 2, 2022 ā€“ Nov 3, 2022
šŸ”“ Past
Advisory Committee Meeting
POSTPONED: October 31, 2022: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
Oct 31, 2022
šŸ”“ Past
Advisory Committee Meeting
UPDATED AGENDA INFORMATION: October 28, 2022: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
Oct 28, 2022
šŸ”“ Past
Advisory Committee Meeting
Best Practices for Utilizing Modeling Approaches to Support Generic Product Development
Oct 27, 2022 ā€“ Oct 28, 2022
šŸ”“ Past
Public
UPDATED CONTACT INFORMATION: October 26, 2022 Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
Oct 26, 2022
šŸ”“ Past
Advisory Committee Meeting
An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs ā€“ General Considerations
Oct 26, 2022
šŸ”“ Past
Webcast
UPDATED INFORMATION: October 17 ā€“ 19, 2022: Hearing Announcement involving the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee
Oct 17, 2022 ā€“ Oct 19, 2022
šŸ”“ Past
Advisory Committee Meeting
UPDATED PUBLIC PARTICIPATION INFORMATION: October 17 -19, 2022: Hearing Announcement involving the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee
Oct 17, 2022 ā€“ Oct 19, 2022
šŸ”“ Past
Public Hearing
FDA NanoDay Symposium 2022
Oct 11, 2022
šŸ”“ Past
Symposium
Challenges and Opportunities for REMS Integration, Innovation, and Modernization
Oct 11, 2022
šŸ”“ Past
Workshop
Study Data Standards Update for CBER: Your Guide to a Successful Submission
Oct 5, 2022
šŸ”“ Past
Webcast
FDA AAPS EUFEPS 5th Annual GBHI Meeting
Sep 28, 2022 ā€“ Sep 29, 2022
šŸ”“ Past
Public
September 22-23, 2022: Meeting of the Oncologic Drugs Advisory Committee Announcement
Sep 22, 2022 ā€“ Sep 23, 2022
šŸ”“ Past
Advisory Committee Meeting
Advancing Generic Drug Development: Translating Science to Approval
Sep 20, 2022 ā€“ Sep 21, 2022
šŸ”“ Past
Workshop
FDA Workshop: Increasing the Efficiency of Biosimilar Development Programs
Sep 19, 2022
šŸ”“ Past
Virtual
FDA/PHUSE Computational Science Symposium
Sep 19, 2022 ā€“ Sep 21, 2022
šŸ”“ Past
Symposium
Advancing Pre-Market Safety Analytics
Sep 14, 2022
šŸ”“ Past
Virtual
2022 PDA/ FDA Joint Regulatory Conference
Sep 12, 2022 ā€“ Sep 14, 2022
šŸ”“ Past
Public
Public Webinar - Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments ā€“ Draft Guidance
Sep 9, 2022
šŸ”“ Past
Webcast
Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act
Sep 8, 2022
šŸ”“ Past
Virtual
Successfully Navigating the USPTO and FDA
Sep 8, 2022
šŸ”“ Past
Virtual
2022 Scientific Computing Days
Sep 7, 2022 ā€“ Sep 8, 2022
šŸ”“ Past
Virtual
September 7, 2022: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement
Sep 7, 2022
šŸ”“ Past
Advisory Committee Meeting
Compounding Quality Center of Excellence Annual Conference
Sep 6, 2022 ā€“ Sep 8, 2022
šŸ”“ Past
Virtual
Drug Development Considerations for the Prevention of Healthcare-Associated Infections
Aug 30, 2022
šŸ”“ Past
Workshop
Regulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines
Aug 16, 2022 ā€“ Aug 18, 2022
šŸ”“ Past
Virtual
Best Practices for Topical Generic Product Development and ANDA Submission
Aug 11, 2022
šŸ”“ Past
Virtual
Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
Aug 10, 2022
šŸ”“ Past
Virtual
Endpoint Considerations to Facilitate Drug Development for Niemann-Pick Type C (NPC): Key Themes and Future Directions from the January 2022 Public Workshop
Aug 4, 2022
šŸ”“ Past
Virtual
Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials: Lessons Learned about Data Collection and Analysis
Jul 25, 2022
šŸ”“ Past
Virtual
Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites
Jul 19, 2022 ā€“ Jul 20, 2022
šŸ”“ Past
Virtual
Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials: Who to Ask and How to Ask
Jun 30, 2022
šŸ”“ Past
Virtual
June 17, 2022 Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement
Jun 17, 2022
šŸ”“ Past
Advisory Committee Meeting
June 8, 2022: Meeting of the Pharmacy Compounding Advisory Committee Meeting Announcement
Jun 8, 2022
šŸ”“ Past
Advisory Committee Meeting
2022 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments
Jun 7, 2022
šŸ”“ Past
Meeting
Regulatory Education for Industry (REdI) Annual Conference 2022
Jun 6, 2022 ā€“ Jun 10, 2022
šŸ”“ Past
Virtual
Development Considerations of Antimicrobial Drugs for the Treatment of Uncomplicated Urinary Tract Infections (UTI) (Virtual)
Jun 3, 2022
šŸ”“ Past
Workshop
FDA and Duke-Margolis Virtual Public Workshop - Translational Science in Drug Development: Surrogate Endpoints, Biomarkers, and More
May 24, 2022 ā€“ May 25, 2022
šŸ”“ Past
Virtual
Quality Management Maturity Workshop
May 24, 2022 ā€“ May 25, 2022
šŸ”“ Past
Virtual
FDA & American College of Rheumatology (ACR) Virtual Summit
May 17, 2022 ā€“ May 18, 2022
šŸ”“ Past
Virtual
FDA CDER & NIH NCATS Regulatory Fitness in Rare Disease Clinical Trials Workshop
May 16, 2022 ā€“ May 17, 2022
šŸ”“ Past
Virtual
Pharmacokinetic Evaluation in Pregnancy- VIRTUAL PUBLIC WORKSHOP
May 16, 2022 ā€“ May 17, 2022
šŸ”“ Past
Virtual
FDA-ASCO Hematology and Oncology Fellows Day Workshop
May 16, 2022
šŸ”“ Past
Workshop
May 11-12, 2022: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting Announcement
May 11, 2022 ā€“ May 12, 2022
šŸ”“ Past
Advisory Committee Meeting
US-Canada Regional ICH Consultation
May 11, 2022
šŸ”“ Past
Virtual
FY 2022 Generic Drug Science and Research Initiatives Public Workshop
May 9, 2022 ā€“ May 10, 2022
šŸ”“ Past
Virtual
FDA Workshop on the Role of Phytosterols in PNALD/IFALD
May 6, 2022
šŸ”“ Past
Virtual
Getting the Dose Right: Optimizing Dose Selection Strategies in Oncology ā€“ An FDA-ASCO Virtual Workshop
May 3, 2022 ā€“ May 5, 2022
šŸ”“ Past
Workshop
Public Workshop: FDA Wound Healing Scientific Workshop
Apr 28, 2022 ā€“ Apr 29, 2022
šŸ”“ Past
Workshop
Generic Drugs Forum 2022: The Current State of Generic Drugs
Apr 26, 2022 ā€“ Apr 27, 2022
šŸ”“ Past
Webcast
2022 FDA/DIA Oligonucleotide-based Therapeutics Conference
Apr 25, 2022 ā€“ Apr 27, 2022
šŸ”“ Past
Conference
UPDATED INFORMATION April 21-22, 2022: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
Apr 21, 2022 ā€“ Apr 22, 2022
šŸ”“ Past
Advisory Committee Meeting
Biosimilars: A Decade of Experience and Future Directionsā€”Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology
Apr 13, 2022
šŸ”“ Past
Webcast
Proposed Rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
Apr 13, 2022
šŸ”“ Past
Virtual
The 16th Annual FDA/DIA Biostatistics Industry and Regulator Forum 2022 (CDER Co-Sponsorship)
Apr 6, 2022 ā€“ Apr 8, 2022
šŸ”“ Past
Forum
FDA Inspections of Outsourcing Facilities
Apr 6, 2022
šŸ”“ Past
Webcast
Immunogenicity Information in Labeling
Apr 5, 2022
šŸ”“ Past
Webcast
Identifying Key Competencies for Opioid Prescriber Education
Apr 4, 2022 ā€“ Apr 5, 2022
šŸ”“ Past
Virtual
UPDATED MEETING TIME AND OPEN PUBLIC HEARING TIME: March 30, 2022: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement
Mar 30, 2022
šŸ”“ Past
Advisory Committee Meeting
Naloxone Access: Answering Questions
Mar 29, 2022
šŸ”“ Past
Public
OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings
Mar 29, 2022
šŸ”“ Past
Webcast
FDA Public Meeting: Identification of Concepts and Terminology for Multi-Component Biomarkers
Mar 23, 2022 ā€“ Mar 24, 2022
šŸ”“ Past
Workshop
Public Meeting: Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act
Mar 22, 2022
šŸ”“ Past
Virtual
FDA-EMA Parallel Scientific Advice (PSA) Program
Mar 16, 2022
šŸ”“ Past
Webcast
FDA PDUFA Hiring and Retention Final Assessment Public Meeting
Mar 15, 2022
šŸ”“ Past
Meeting
FDA, MHRA, and Health Canada Good Clinical Practice Workshop: Global Clinical Trials - Considerations and Lessons Learned from the Changing Landscape (2022)
Mar 7, 2022 ā€“ Mar 9, 2022
šŸ”“ Past
Virtual
46th International Good Manufacturing Practices Conference
Mar 7, 2022 ā€“ Mar 10, 2022
šŸ”“ Past
Virtual
Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
Feb 24, 2022
šŸ”“ Past
Webcast
CDER BIMO GCP Compliance and Enforcement
Feb 16, 2022
šŸ”“ Past
Webcast
February 15, 2022: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee
Feb 15, 2022
šŸ”“ Past
Advisory Committee Meeting
February 10, 2022: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
Feb 10, 2022
šŸ”“ Past
Advisory Committee Meeting
Digital Health Technologies (DHTs) for Remote Data Acquisition Draft Guidance
Feb 10, 2022
šŸ”“ Past
Webcast
Toward Global Identification of Medicinal Products (IDMP) Implementation: A Focus on Biologics
Jan 27, 2022
šŸ”“ Past
Webcast
Endpoint Considerations to Facilitate Drug Development for Niemann-Pick Type C (NPC) Public Workshop
Jan 24, 2022 ā€“ Jan 25, 2022
šŸ”“ Past
Workshop
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