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Tab 19 - FDA Draft Guidance on Buprenorphine Hydrochloride Buccal 2025

May 1, 2026 - Jul 19, 2026

🟢 Open (1 days left)

Program:CDER

Agency:FDA

Docket ID:FDA-2026-P-4762

Legacy ID:

Reference 3 - Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; Draft Guidance for Industry*, Sept. 2023

Apr 15, 2026 - Jul 19, 2026

🟢 Open (1 days left)

Program:CBER

Agency:FDA

Docket ID:FDA-2026-D-1255

Legacy ID:

Reference 6 - Guidance for Industry and for FDA Reviewers: Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997, issued on August 9, 2000

Nov 25, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CDRH

Agency:FDA

Docket ID:FDA-2025-N-4622

Legacy ID:

Exhibit 11 - FDA Dosage and Administration Guidance Jan. 2023 Rev 1

Nov 12, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CDER

Agency:FDA

Docket ID:FDA-2025-P-6019

Legacy ID:

Summary:

- **Draft Guidance**: This document is a draft for industry, open for public comments within 60 days of Federal Register publication.
- **Purpose**: Provides recommendations for the "Dosage and Administration" section of labeling for human prescription drugs and biological products.
- **Key Sections**: Covers critical information, dosage modifications, administration instructions, and special populations (e.g., pediatric, renal/hepatic impairment).
- **Nonbinding**: Guidance is nonbinding; alternative approaches may be used if compliant with regulations.
- **Contact Info**: Comments can be submitted electronically or via mail to FDA, with specific contact details for CDER and CBER.
- **Availability**: Additional copies and updates can be obtained from FDA�s official websites or offices.

Exhibit 18 - FDA Revising ANDA Labeling Following Revision of the RLD Labeling Guidance Jan. 2024

Nov 12, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CDER

Agency:FDA

Docket ID:FDA-2025-P-6019

Legacy ID:

Summary:

- **Purpose**: Guidance assists ANDA holders in updating labeling after revisions to the RLD (Reference Listed Drug) labeling, ensuring consistency with FDA requirements.
- **Scope**: Applies to prescription and certain OTC generic drugs, covering Prescribing Information, Medication Guides, and container labeling.
- **Monitoring RLD Changes**: ANDA holders must routinely check Drugs@FDA and FDA LISTSERVs for RLD labeling updates to ensure timely revisions.
- **Submission Process**: Revised ANDA labeling must be submitted electronically via the Electronic Submissions Gateway, following eCTD specifications.
- **Types of Submissions**: Vary by ANDA status (unapproved, tentatively approved, or approved) and may require prior approval supplements or other reporting categories.
- **Compliance**: Failure to update labeling promptly may lead to FDA withdrawal of ANDA approval, as generic drugs must match RLD labeling (with permissible differences).

Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency Guidance for Industry and FDA

Sep 23, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CDRH

Agency:FDA

Docket ID:FDA-2023-D-5365

Legacy ID:

Summary:

- Guidance for industry and FDA staff on considering enforcement policies for unapproved in vitro diagnostic tests during a Section 564 declared emergency.
- FDA may issue an enforcement policy indicating its intent not to object to the limited offering of certain unapproved tests to help increase availability, outlining scope, rationale, performance expectations, and duration.
- FDA considers public health need, benefits and risks, availability of alternatives, and risk mitigations when deciding to begin or end an enforcement policy:
- Public health need: testing needs, time sensitivity, transmission levels, potential for asymptomatic infections, population size, morbidity and mortality rates, and type of diagnostic test required.
- Benefits and risks: known or potential benefits and risks, and sufficient mitigations to address risks of false results.
- Alternatives: availability of approved or authorized in vitro diagnostic tests.

Unique Device Identifier Requirements for Combination Products; Draft Guidance for Industry and FDA Staff; Availability

Jun 26, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:OC

Agency:FDA

Docket ID:FDA-2025-D-0176

Legacy ID:

Summary:

- HHS announces a grant for a national communication system, NHTH, to assist victims of severe forms of human trafficking.
- NHTH objectives include operating 24/7 services, providing timely info and referrals to victims, notifying law enforcement, and maintaining an online directory of service providers.
- Grant recipient collects info about signalers and potential victims, reporting in the aggregate to HHS for monitoring, informing anti-trafficking strategies, and providing outcome info to Congress and public.
- Estimated total annual burden hours for this collection is 25,621.
- FDA announces draft guidance for industry and staff on UDI requirements for combination products, available for comments until September 24, 2025.
- FDA also announces modifications to the list of recognized standards for medical devices under the Food and Drug Administration Modernization Act of 1997.

- The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled "Unique Device Identifier (UDI) Requirements for Combination Products."
- The guidance is intended to assist industry and FDA staff in understanding how FDA's unique device identifier (UDI) requirements apply to combination products with device constituent parts.
- The draft guidance outlines the requirements, recommendations, and best practices for UDI labeling and for submission of information to the Global Unique Device Identification Database for combination products.
- The FDA requests public comment on the draft guidance by September 24, 2
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Unique Device Identifier Requirements for Combination Products; Draft Guidance for Industry and FDA Staff

Jun 26, 2025 - Sep 25, 2025

🔴 Closed

Program:OC

Agency:FDA

Docket ID:FDA-2025-D-0176

Legacy ID:

Summary:

- Guidance document for UDI requirements of combination products, open for public comment
- UDI requirements apply to combination products with device constituent parts, except when all device parts are excepted
- FDA recommends using UDI for device parts of single-entity combination products, and NDC for co-packaged products
- For co-packed products, the labeler should submit information for the device part to the GUDID
- Examples of UDI application for single-entity and co-packed combination products are provided
- Comments on the draft guidance should be submitted electronically or in writing within 90 days of publication.

Attachment 4 - Product specific Draft Guidance on Maribavir tablets FDA October 2024

Jun 25, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CDER

Agency:FDA

Docket ID:FDA-2025-P-1926

Legacy ID:

Summary:

- Draft Guidance on Maribavir, non-binding and not for implementation, reflects current FDA thinking.
- Recommended study: single-dose, two-treatment, two-period crossover bioequivalence study with 200 mg Maribavir tablet for healthy male and non-pregnant female subjects.
- Dissolution testing: conduct comparative dissolution testing on 12 dosage units each for test product and RLD, specifications determined upon review of the abbreviated new drug application.
- In vitro feeding tube studies: conduct studies with NG and OG tubes made of three different materials and designs, holding times of 0 and 15 minutes after dispersion, testing strength of 200 mg.
- Dispersion and rinse media: constitute oral suspension with 30 mL of drinking water or sterile water, flush with 15 mL of water before and after enteral administration.
- This draft guidance is recommended May 2023 and revised Oct 2024, with unique agency identifier PSG\_215596.

Reference 3 - �Guidance for Industry and for FDA Reviewers: Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997,� issued on August 9, 2000

Jun 11, 2025 - Jun 18, 2025

🔴 Closed

Program:CDRH

Agency:FDA

Docket ID:FDA-2025-N-1243

Legacy ID:

Summary:

- Guidance issued by U.S. Department of Health and Human Services, Food and Drug Administration (FDA) on August 9, 2000.
- Provides interpretation of Section 216 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) for industry and FDA reviewers.
- Establishes the six-year rule, under which data from a premarket approval application can be used by the FDA after 6 years of approval for various purposes.
- CDRH will apply section 216 to freedata only in PMAs approved after November 28, 1990, the date of enactment of the SMDA.
- Comments and suggestions regarding this document should be submitted to Docket No. 00D-1274 until November 7, 2000, and thereafter to Thinh Nguyen, Center for Devices and Radiological Health.
- The guidance represents FDA's current thinking on the interpretation of section 216 of the Food and Drug Administration Modernization Act of 1997 and does not create or confer any rights.

Attachment B (FDA Final Guidance for Industry on Action Levels for Lead in Food Intended for Babies and Young Children)

May 6, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CFSAN

Agency:FDA

Docket ID:FDA-2021-P-1144

Legacy ID:

Summary:

- This document is a guidance for industry from the FDA regarding action levels for lead in processed food intended for babies and young children.
- The action levels are not binding and are intended to be achievable when control measures are taken to minimize lead presence.
- The action levels for processed foods intended for babies and young children are: 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats; 20 ppb for single-ingredient root vegetables; and 20 ppb for dry infant cereals.
- The guidance is not intended to direct consumers in making food choices and encourages a varied and nutrient-dense diet for children.
- Lead is toxic and can be harmful to vulnerable populations, including infants, young children, and pregnant women.
- The guidance is part of the FDA's Closer to Zero initiative to decrease toxic elements, including lead, in foods over time.

Attachment 5 - FDA Draft Guidance on Meloxicam

Jan 29, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CDER

Agency:FDA

Docket ID:FDA-2025-P-0343

Legacy ID:

Summary:

- This is a draft guidance on Meloxicam, not for implementation, and contains nonbinding recommendations.
- Recommends one in vivo bioequivalence study with pharmacokinetic endpoints for Meloxicam tablet, 15 mg strength.
- Suggests a waiver request of in vivo testing for 7.5 mg strength based on certain conditions.
- Provides dissolution test method and sampling times for Meloxicam drug product.
- Document history includes recommendation in May 2007, finalization in May 2008, and revision in October 2024.
- Unique Agency Identifier: PSG\_020938, if the RLD is not available, refer to the FDA guidance for industry.

Ref 8. FDA Draft Guidance for Industry

Jan 27, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CFSAN

Agency:FDA

Docket ID:FDA-2022-D-0278

Legacy ID:

Summary:

- Guidance for industry on Hazard Analysis and Risk-Based Preventive Controls for Human Food, draft version being distributed for comment purposes.
- Outlines components of a food safety plan, hazard analysis, preventive controls, monitoring, corrective actions, verification, and records.
- Provides guidance on identifying and applying preventive control management components for biological, chemical, and physical hazards.
- Intended for those subject to PCHF requirements in part 117 of 21 CFR, not for those exempt or subject to modified requirements.
- Glossary of terms used in the guidance includes definitions established in 21 CFR 117.3.
- Comment period is 180 days from publication in the Federal Register.

48 FDA Guidance for Industry Use of NAT on samples 2012 UCM327895

Jan 14, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CBER

Agency:FDA

Docket ID:FDA-2022-D-0465

Legacy ID:

Summary:

- Guidance for blood establishments on using FDA-licensed nucleic acid tests (NAT) to screen donors for hepatitis B virus (HBV) DNA and reduce risk of HBV transmission.
- Recommends using HBV NAT in addition to HBsAg and anti-HBc tests for Whole Blood, blood components, Source Plasma, and Source Leukocytes.
- Discusses donor management and requalification, product testing and disposition, and labeling for reactive units.
- HBV NAT can detect infection earlier than HBsAg and anti-HBc tests, reducing risk of transmission from asymptomatic donors in the window period.
- Implementing HBV NAT has the potential to reduce risk of infection to levels similar to HIV and HCV.
- FDA may update testing recommendations as technology advances and more data becomes available.

55 FDA Guidance NAT for HIV-1 and HCV

Jan 14, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CBER

Agency:FDA

Docket ID:FDA-2022-D-0467

Legacy ID:

Summary:

- Guidance for industry on NAT testing for HIV-1 and HCV in blood donors
- Immediate implementation, comments welcome via regulations.gov or mail
- Revised recommendations for HCV reactive donors due to discontinuation of RIBA test
- Updated definition of "Discriminatory NAT" and regulatory citations
- Background discussion includes current estimates of HIV-1 and HCV in blood donations
- Contains nonbinding recommendations on testing algorithms, donor management, and reentry.

166 FDA Guidance Use of NATs on Pooled a Individual Samples Donors

Jan 14, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CBER

Agency:FDA

Docket ID:FDA-2022-D-0467

Legacy ID:

Summary:

- FDA has licensed NAT tests for donor screening of HIV-1 and HCV RNA, which can detect infection at an earlier stage than previously approved tests.
- These NAT tests are now widely available and meet criteria for reducing the risk of communicable disease transmission through blood products.
- Licensed blood and Source Plasma manufacturers are required to report manufacturing changes, including donor testing, to FDA.
- FDA recommends using an FDA licensed donor screening test for the detection of antibodies to HIV-1 and HCV, followed by NAT testing for donations that are negative or non-reactive.
- For HIV-1, if a donation is reactive on a test for the detection of antibodies, additional testing with NAT is not necessary if the donation will be discarded or used in the manufacture of non-injectable products.
- For HCV, if a donation is reactive on a test for the detection of antibodies, additional testing with NAT is recommended if the donation will be used for autologous transfusion or for further manufacturing into injectable products.

95 FDA Guidance Use of NAT Donors of Whole Bld Plasma

Jan 13, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CBER

Agency:FDA

Docket ID:FDA-2022-D-0466

Legacy ID:

Summary:

- FDA has licensed NAT (nucleic acid tests) for donor screening of HIV-1 and HCV RNA.
- These NAT tests can detect infection at an earlier stage than previously approved tests.
- FDA recommends using NAT for donor screening to reduce the risk of transmission of communicable diseases.
- Blood and plasma manufacturers must report changes in donor testing to FDA.
- NAT can be used for both pooled and individual samples from donors of whole blood and blood components.
- Implementation of NAT for donor screening should be in accordance with FDA regulations and guidance.

02 FDA Guidance - CGTP and add Requ Manufacturers HCTPs Dec2011

Jan 12, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CBER

Agency:FDA

Docket ID:FDA-2022-D-0464

Legacy ID:

Summary:

- Guidance document for Current Good Tissue Practice (CGTP) and additional requirements for manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
- CGTP requirements include core CGTP, exemptions and alternatives, quality program establishment and maintenance, personnel, procedures, facilities, environmental control and monitoring, equipment, supplies and reagents, recovery, processing and process controls, process changes, process validation, labeling controls, storage, and receipt, predistribution shipment, and distribution of an HCT/P
- Outlines steps to ensure that contracted establishments comply with CGTP requirements and corrective actions when non-compliance occurs
- Explanation of when CGTP requirements must be followed, even if HCT/Ps are also regulated as a biological product, drug, or device
- Provides information on requesting exemptions or alternatives from CGTP requirements and establishes quality program requirements.
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Reference 28 - FDA. 2024. �Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry (Draft Guidance).� Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-hazard-analysis-and-risk-based-preventive-controls-human-food.

Jan 8, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CFSAN

Agency:FDA

Docket ID:FDA-2024-D-2604

Legacy ID:

Summary:

- This guidance, when finalized, represents FDA's current thinking on Hazard Analysis and Risk-Based Preventive Controls for Human Food.
- It provides guidance on components of a food safety plan, hazard analysis, preventive controls, monitoring, corrective actions, verification, and associated records.
- It aims to help those subject to PCHF requirements comply with specific regulations, identify preventive controls for common hazards, and understand recordkeeping requirements.
- The guidance includes a glossary of terms and definitions, which may change through future rulemaking.
- It is not legally binding, but recommendations should be considered and tailored to specific circumstances for the foods processed.
- Comments and questions can be submitted electronically or in writing to FDA's Technical Assistance Network.

Reference 42 - FDA. 2016. Guidance for Industry: Exempt Infant Formula Production. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-exempt-infant-formula-production.

Jan 8, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CFSAN

Agency:FDA

Docket ID:FDA-2024-D-2604

Legacy ID:

Summary:

- This document, "Guidance for Industry Exempt Infant Formula Production," provides recommendations from the FDA on current good manufacturing practices (CGMPs), quality control procedures, audits, and records and reports for exempt infant formula production.
- Exempt infant formulas are those represented and labeled for use by infants with inborn errors of metabolism, low birth weight, or other unusual medical or dietary problems, and are exempt from certain requirements of the FD&C Act.
- The FDA has established regulations for non-exempt infant formulas, and intends to promulgate regulations for any new terms and conditions for exempt infant formulas in a future rulemaking.
- This guidance recommends that manufacturers of exempt infant formulas follow subparts A, B, C, D, and F of 21 CFR part 106, as amended or established by the final rule published on June 10, 2014, to ensure the production of safe and nutritionally adequate products.
- The FDA recommends these practices to ensure the integrity and nutritional adequacy of exempt infant formulas, which are often the sole source of nutrition for vulnerable infants.
- Comments regarding this guidance can be submitted electronically or in writing to the FDA at any time, and should be identified with the docket number listed in the notice of availability that pub

Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Guidance for Industry; Availability; Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request

Jan 7, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:OC

Agency:FDA

Docket ID:FDA-2008-D-0053

Legacy ID:

Summary:

- The FDA has announced the availability of a final guidance for industry titled 'Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.'
- This guidance outlines the FDA's enforcement policy regarding firm-initiated communications of scientific information on unapproved uses of approved/cleared medical products to healthcare providers.
- The guidance is not currently in effect and is pending the Office of Management and Budget's (OMB) decision on the collection of information.
- The FDA is seeking comments on the collection of information related to the guidance, with written comments due by February 21, 2025.
- Comments may be submitted electronically or in written/paper form, and should include the Docket No. FDA�2008�D�0053.
- The guidance is available for public viewing and comment at <https://www.regulations.gov> and at the Dockets Management Staff in Rockville, MD.

- The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry titled �Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.�
- This guidance describes FDA's enforcement policy regarding certain firm-initiated communications of scientific information on unapproved uses of approved/cleared medical products to health care providers.
- The guidance finalizes the revised draft guidance of the same title issued in October 2023, which itself revised the final guidance issued in January 2009.
- The guidance is not for current implementation and is pending the Office of Management and Budget�s (OMB�s) decision on the collection of information.
- Written comments on the collection of information are being accepted until February 21, 2025.
- The guidance provides recommendations for firms initiating the sharing with health care providers of specific types of firm-initiated communications, referred to as scientific information on unapproved use(s) of approved/cleared medical product communications.

Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Guidance for FDA Staff and Interested Parties; Availability

Jan 7, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CFSAN

Agency:FDA

Docket ID:FDA-2021-N-0553

Legacy ID:

Summary:

- FDA announces availability of final guidance for evaluating public health importance of food allergens other than major allergens listed in the FD&C Act.
- Guidance outlines approach FDA generally intends to take when evaluating public health importance of non-listed food allergens.
- Focus of guidance is primarily IgE-mediated food allergy, but FDA will evaluate other food allergens on a case-by-case basis.
- Regulatory framework of FD&C Act applies to production of food containing food allergen through provisions regarding food labeling, production, and safety of substances added to food.
- FDA considered all comments received during the comment period before developing the final guidance.
- Guidance contains no collection of information, but refers to previously approved FDA collections of information under the Paperwork Reduction Act of 1995.

- FDA announces availability of final guidance for evaluating the public health importance of food allergens other than the major ones listed in the FD&C Act
- Guidance outlines FDA�s general approach when evaluating non-listed food allergens
- Includes scientific factors and information relevant to labeling and production of food containing non-listed food allergens
- Describes recommendations for identifying and evaluating evidence applicable to an evaluation of non-listed food allergens
- Focus is primarily on IgE-mediated food allergies, with potential evaluation of other types of food allergens on a case-by-case basis
- Changes to guidance include clarification on non-IgE-mediated reactions, updated text and reference, and expanded discussion on prevalence data.

Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act: Guidance for FDA Staff and Interested Parties

Jan 7, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CFSAN

Agency:FDA

Docket ID:FDA-2021-N-0553

Legacy ID:

Summary:

- Guidance for FDA staff and interested parties on evaluating the public health importance of food allergens other than the major ones listed in the Federal Food, Drug, and Cosmetic Act.
- Provides recommendations on identifying and evaluating the body of evidence applicable to scientific factors, including IgE-mediated food allergy, prevalence, severity, and allergenic potency.
- Describes FDA's evaluation process, including consideration of information relevant to food labeling and production.
- Outlines the process for interested parties to submit a citizen petition asking FDA to establish regulatory requirements based on the public health importance of a non-listed food allergen.
- Contains nonbinding recommendations and does not establish any rights for any person or binding requirements on FDA or the public.
- Defines terms and abbreviations used in the guidance, including anaphylaxis, allergen cross-contact, allergenic potency, community report, cross-reactivity, food allergen, food allergy, food challenge, food hypersensitivity, food intolerance, frequency dose-response, historical information, IgE-mediated food allergy, interested FDA staff, major food allergen, objective signs of food allergy, oral allergy syndrome, petitioner, pre-market approval, and reasonably certain.

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff

Jan 7, 2025 - Jul 19, 2026

🟢 Open (1 days left)

Program:CDRH

Agency:FDA

Docket ID:FDA-2022-D-0053

Legacy ID:

Summary:

- Guidance for industry and FDA staff on notifying FDA of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act.
- Manufacturers of certain devices must notify FDA of a permanent discontinuance or interruption that is likely to lead to a meaningful disruption in the supply of that device during or in advance of a public health emergency.
- Notifications should include information about the reasons for the discontinuance or interruption, the expected duration, and any measures being taken to mitigate the disruption.
- Manufacturers should use the FDA's 506J Device List to determine if their device is subject to the notification requirements.
- Failure to notify FDA may result in FDA issuing a letter informing the manufacturer of the failure and expediting inspections and premarket review to help mitigate or prevent the shortage.
- For questions regarding 506J notifications, manufacturers should contact CDRHManufacturerShortage@fda.hhs.gov for devices regulated by CDRH or cbershortage@fda.hhs.gov for devices regulated by CBER.

Combined FDA and Sponsor Oncologic Drugs Advisory Committee Briefing Document; Guidance for Industry - Draft Guidance

Dec 30, 2024 - Mar 1, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2024-D-4490

Legacy ID:

Summary:

1. This document is a draft guidance from the Food and Drug Administration (FDA) regarding the use of a combined briefing document for matters before the Oncologic Drugs Advisory Committee (ODAC). It contains nonbinding recommendations and is not for implementation.
2. FDA customarily prepares separate ODAC briefing documents, which can lead to repetition and an increase in documents for committee members to review. Project Point/Counterpoint is an option for advisory committee meetings for oncology products.
3. A combined briefing document includes information that would typically be contained in separate briefing documents prepared by the Sponsor and FDA. It may provide efficiencies by allowing both parties to present their views on key issues in a single document.
4. Sponsors should inform FDA of their interest in using the combined briefing document early in the ODAC process. FDA provides a blank template within two weeks of determining that a product will be discussed at ODAC.
5. The Sponsor completes their sections in the combined briefing document template, explaining their positions and formatting the document to meet 508 compliance standards. They should submit it to the appropriate FDA review division at least eight weeks prior to the scheduled ODAC.
6. FDA reviews all documents submitted by the Sponsor for the NDA/BLA and adds its assessment in separate sections

Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula: Guidance for Industry; Draft Guidance

Dec 4, 2024 - Feb 4, 2025

🔴 Closed

Program:CFSAN

Agency:FDA

Docket ID:FDA-2024-D-1334

Legacy ID:

Summary:

1. This document is a draft guidance from the US Food and Drug Administration (FDA) regarding notifying the agency of permanent discontinuances or interruptions in the manufacture of infant formula.
2. The guidance contains nonbinding recommendations and is distributed for comment purposes only, with a 75-day deadline for submitting comments.
3. Under Section 424(a)(1) of the Federal Food, Drug, and Cosmetic Act, manufacturers must notify FDA of a permanent discontinuance or interruption in manufacture of a critical food, including infant formula, that is likely to lead to a meaningful disruption in supply within 5 business days.
4. The guidance explains that "permanent discontinuance" for infant formula refers to a manufacturer's decision to cease manufacturing and distributing the product indefinitely, and interruptions in manufacturing must be reported if they are reasonably likely to lead to a significant reduction in the supply of the critical food.
5. The document provides recommendations on procedures for submitting notifications and failure to notify FDA, as well as contact information for questions.
6. The guidance applies specifically to infant formula but is relevant to manufacturers of other critical foods as well.

PSG_009170 - Draft Guidance on Primidone

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This is a draft guidance on Primidone tablets by the FDA, not for implementation (November 2024).
* The document represents the current thinking of the FDA and is non-binding.
* Contains recommendations for one in vivo bioequivalence study with pharmacokinetic endpoints.
* Dissolution testing required, conducting comparative dissolution testing on 12 dosage units for all strengths.
* Specifications will be determined upon review of the Abbreviated New Drug Application (ANDA).
* Additional dissolution profile testing for split tablets if necessary, as per FDA guidance on Tablet Scoring.

PSG_010104 - Draft Guidance on Phytonadione

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This is a draft guidance from the Food and Drug Administration (FDA) on using Phytonadione as an active ingredient in oral tablets.
* The document contains nonbinding recommendations and is not for implementation.
* Two in vivo bioequivalence studies with pharmacokinetic endpoints are recommended, one fasting and the other fed.
* For each study, healthy males and non-pregnant, non-lactating females should be used as subjects, and phytonadione levels should be measured in plasma.
* The bioequivalence of Phytonadione (E isomer) should be demonstrated, but data for the Z isomer should also be submitted for comparison purposes.
* Additional information includes dissolution testing requirements, drug substance specifications, and document history.

PSG_011745 - Draft Guidance on Phytonadione

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

1. This document is a draft guidance for FDA's current thinking on Phytonadione in injectable form, not binding or enforceable.
2. Two options for demonstrating bioequivalence: Option 1 - In vitro characterization studies, and Option 2 - Two in vivo bioequivalence studies with pharmacokinetic endpoints.
3. Under Option 1, a generic phytonadione injectable injection product should be qualitatively and quantitatively the same as the reference listed drug regarding inactive ingredients.
4. Applicants must provide physicochemical characterization data to demonstrate the test product is a thermodynamically stable micellar solution under Option 1.
5. For Option 2, applicants must conduct two in vivo bioequivalence studies with pharmacokinetic endpoints for both 10 mg/mL and 1 mg/0.5 mL strengths.
6. Applicants should measure phytonadione in plasma (both E isomer and Z isomer) under Option 2, and meet specific requirements for the Z isomer data submission.

PSG_016084 - Draft Guidance on Allopurinol

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance on the use of Allopurinol in tablet form for oral administration.
* Contains nonbinding recommendations for one in vivo bioequivalence study with pharmacokinetic endpoints.
* Study design is single-dose, two-treatment, two-period crossover in vivo with a strength of 300 mg.
* Subjects are healthy males and non-pregnant, non-lactating females. Analyte to measure is Allopurinol in plasma.
* Waiver request for in vivo testing possible for 100 mg and 200 mg strengths with acceptable bioequivalence study on the 300 mg strength, acceptable in vitro dissolution testing, and proportional similarity of formulations.
* Dissolution testing required on 12 dosage units for each strength using FDA's Dissolution Methods database and specifications determined upon review of the abbreviated new drug application. Additional testing may be necessary for split tablets.

PSG_016084-Sus - Draft Guidance on Allopurinol

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

1. FDA's draft guidance on Allopurinol, recommended for November 2024, contains nonbinding recommendations for two options for bioequivalence studies for the suspension form of Allopurinol.
2. Option 1 requires conducting two in vivo bioequivalence studies with pharmacokinetic endpoints using the designated reference standard (RS) for Allopurinol tablets.
3. Option 2 involves one in vivo bioequivalence study with pharmacokinetic endpoints using the designated RS for Allopurinol suspension, and an additional study under fed conditions may be necessary for high-risk products.
4. Bioequivalence is determined based on a 90% confidence interval for Allopurinol in plasma. A waiver request for in vivo testing is not applicable.
5. Comparative dissolution testing is conducted on 12 dosage units for each of the test product and the RS, and specifications will be determined upon review of the Abbreviated New Drug Application.
6. The document history recommends November 2024, with a unique agency identifier PSG_016084-Sus. This draft guidance represents the current thinking of FDA but is not binding and can be viewed as recommendations unless specific regulatory or statutory requirements are cited.

PSG_017533-Sus - Draft Guidance on Clonazepam

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance from the Food and Drug Administration (FDA) on clonazazepam suspension, not for implementation.
* It contains nonbinding recommendations and does not establish any rights or bind FDA or the public.
* Two options are recommended for demonstrating bioequivalence: Option 1 is conducting two in vivo studies with pharmacokinetic endpoints using the designated reference standard (RS) for clonazepam tablets, and Option 2 is conducting one in vivo study with pharmacokinetic endpoints using the designated RS for clonazepam suspension.
* For both options, a single-dose, two-treatment, two-period crossover in vivo design is suggested, testing 1 mg (5 mL) of the clonazepam suspension against the same dose of the RS.
* Additional comments include ensuring adequate washout periods between treatments and testing on healthy males and non-pregnant, non-lactating females.
* Bioequivalence is based on a 90% confidence interval for clonazepam in plasma, and a waiver request of in vivo testing is not applicable. Comparative dissolution testing on 12 dosage units for each product is necessary, and specifications will be determined upon review of the abbreviated new drug application.

PSG_018687 - Draft Guidance on Labetalol Hydrochloride

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance from the Food and Drug Administration (FDA) on Labetalol Hydrochloride tablets for oral use.
* Contains non-binding recommendations for two options to demonstrate bioequivalence: BCS (Biopharmaceutics Classification System) based biowaiver or one in vivo bioequivalence study with pharmacokinetic endpoints.
* Draft is not binding and can be used as a reference, the FDA's finalized thinking on the topic will represent current guidelines.
* Option 1: BCS Class I-based biowaiver may be considered for all strengths if documentation regarding high solubility, high permeability, and rapid dissolution is provided in the application.
* Option 2: One in vivo bioequivalence study with pharmacokinetic endpoints is required for 200 mg strength, and waiver requests for 100 mg, 300 mg, and 400 mg strengths can be made based on an acceptable bioequivalence study, acceptable in vitro dissolution testing, and proportional similarity of the formulations across all strengths.
* The document was last updated in November 2024.

PSG_020216 - Draft Guidance on Estrogens, Conjugated

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This draft guidance is for developing generic drug products of conjugated estrogens vaginal topical cream derived from pregnant mares' urine.
* Recommendations include demonstrating active ingredient sameness through comparative physicochemical characterizations using USP GC method, FDA LC-MS method, or suitable in-house methods.
* Testing should be conducted on six different batches of RLD creams and six different batches of test drug substance/product.
* Use UHPLC-HRMS for chemical characterization; materials include methanol, water, acetonitrile, ammonium acetate, and steroidal standards like Estrone-3-sulfate, Equilin-3-sulfate, DHES, and Dihydroequiin-3-sulfate-17?.
* Prepare the qualifying standards by preparing a 0.100 mg/mL solution of each standard in methanol; use an ultra-high performance liquid chromatography high resolution mass spectrometer for analysis.
* Report RRt and exact mass for each peak, as well as matching peaks with appropriate peak numbers from Table 2.

PSG_020281 - Draft Guidance on Tramadol Hydrochloride

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance from the Food and Drug Administration (FDA) on Tramadol Hydrochloride tablets, not for implementation.
* Contains nonbinding recommendations, FDA's current thinking on the topic, and does not establish legally enforceable responsibilities.
* Recommends one in vivo bioequivalence study with pharmacokinetic endpoints for Tramadol Hydrochloride tablets (25 mg, 50 mg, 75 mg, 100 mg).
* Study design: Single-dose, two-treatment, two-period crossover in vivo. Monitor vital signs and follow REMS/ETASU protocols.
* Analyte to measure: Tramadol in plasma; bioequivalence based on 90% CI for Tramadol.
* Waiver request for in vivo testing for 25 mg, 50 mg, and 75 mg strengths based on acceptable bioequivalence study (100 mg), acceptable in vitro dissolution testing, and proportional similarity of formulations across all strengths.

PSG_020692 - Draft Guidance on Salmeterol Xinafoate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance on the use of Salmeterol Xinafoate Inhalation Powder, not for implementation (November 2024).
* It contains nonbinding recommendations from the Food and Drug Administration (FDA).
* Two options are provided to demonstrate bioequivalence: Option 1 includes three in vitro bioequivalence studies, one comparative characterization study, and two in vivo bioequivalence studies with pharmacokinetic endpoints. Option 2 includes two in vitro bioequivalence studies, one in vivo bioequivalence study with pharmacokinetic endpoints, and one comparative clinical endpoint bioequivalence study.
* For Option 1, the test product should have no difference in inactive ingredients or formulation aspects that affect the local or systemic availability of Salmeterol Xinafoate. Q1 (qualitative sameness) means using the same inactive ingredient(s), and Q2 (quantitative sameness) means concentrations within � 5% of those used in the reference standard product.
* The FDA recommends conducting three in vitro bioequivalence studies for the T and RS products, using at least three batches each, with no fewer than 10 units from each batch, and performing a single actuation content (SAC) and aerodynamic particle size distribution

PSG_020831 - Draft Guidance on Formoterol Fumarate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document provides draft guidance on Formoterol Fumarate for inhalation, which is not for implementation and contains nonbinding recommendations from the Food and Drug Administration (FDA).
* The recommended studies for demonstrating bioequivalence include two options: option 1 involves six in vitro bioequivalence studies, one comparative characterization study, and two in vivo bioequivalence studies with pharmacokinetic endpoints; or option 2 includes two in vitro bioequivalence studies, one in vivo bioequivalence study with pharmacokinetic endpoints, and one comparative clinical endpoint bioequivalence study.
* For option 1, the test product (T) should have no difference in inactive ingredients or other aspects of the formulation that may affect the local or systematic availability of the active ingredient compared to the reference standard (RS).
* In vitro bioequivalence studies should be conducted on the final device constituent part and final drug constituent formulation intended to be marketed, using at least three batches each for T and RS products with no fewer than 10 units per batch. Three primary stability batches are also recommended.
* Bioequivalence can be demonstrated through population bioequivalence analysis of single actuation content (SAC) or aerodynamic particle size distribution (APSD). For APSD, studies should be

PSG_020833 - Draft Guidance on Fluticasone Propionate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document provides draft guidance on the use of Fluticasone Propionate inhalation powder, but it is not binding and does not establish legally enforceable responsibilities.
* Contains recommendations for two options to demonstrate bioequivalence: Option 1 involves conducting four in vitro bioequivalence studies, one comparative characterization study, and one in vivo bioequivalence study with pharmacokinetic endpoints; Option 2 involves conducting two in vitro bioequivalence studies, one in vivo bioequivalence study with pharmacokinetic endpoints, and one comparative clinical endpoint bioequivalence study.
* Recommends that prospective applicants conduct in vitro bioequivalence studies for all strengths of the test (T) product using three batches each of the T and reference standard (RS) products, and three primary stability batches.
* Details the design and requirements for various types of bioequivalence studies including single actuation content (SAC), aerodynamic particle size distribution (APSD), and dissolution tests.
* Bioequivalence is based on population bioequivalence analysis of ISM or other appropriate statistical analysis for each mouth-throat model-breathing profile combination.
* Submission of cascade impactor profiles, mass median aerodynamic diameter (MMAD), geometric standard deviation (GSD), and

PSG_021077 - Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance from the Food and Drug Administration (FDA) on Fluticasone Propionate and Salmeterol Xinafoate inhalation powder.
* It contains nonbinding recommendations and is not for implementation, with a target date of November 2024.
* The document recommends two options for demonstrating bioequivalence: Option 1 involves conducting four in vitro bioequivalence studies, one comparative characterization study, and two in vivo bioequivalence studies with pharmacokinetic endpoints; or Option 2 involves conducting two in vitro bioequivalence studies, one in vivo bioequivalence study with pharmacokinetic endpoints, and one comparative clinical endpoint bioequivalence study.
* The active ingredients are Fluticasone Propionate and Salmeterol Xinafoate, the dosage form is Powder, and the route is Inhalation.
* The recommended studies include in vitro and in vivo bioequivalence studies to demonstrate equivalent APSD (aerodynamic particle size distribution), impactor-sized mass, and dissolution profiles for fluticasone propionate.
* Bioequivalence is based on population bioequivalence analysis of ISM (impactor-sized mass) or other appropriate statistical analyses for each mouth-throat model-breath

PSG_021184-Cre-0.05P - Draft Guidance on Tazarotene

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document provides nonbinding recommendations for FDA's draft guidance on Tazarotene topical cream 0.05%
* The document is not final and does not establish legally enforceable responsibilities, it only describes the current thinking of FDA
* Two options are available to demonstrate bioequivalence: Option 1 with two in vitro studies or Option 2 with one comparative clinical study
* For option 1, criteria include equivalent formulation composition, same physicochemical and structural attributes, and equivalent rate of active ingredient release
* For option 2, a randomized, double-blind, parallel, placebo-controlled in vivo study is recommended for 84 days to test the proportion of treatment success
* Inclusive criteria include males or non-pregnant females over 18 with stable plaque psoriasis involving at least 2% and no more than 20% BSA, and a minimum plaque elevation of moderate severity. Females must have a negative pregnancy test and agree to use acceptable birth control.

PSG_021190 - Draft Guidance on Buspirone Hydrochloride

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* The document is a draft guidance from the Food and Drug Administration (FDA) on Buspirone Hydrochloride, released in November 2024.
* It contains nonbinding recommendations and is not for implementation. FDA's guidances describe current thinking but are not legally binding.
* The recommended study for Bioequivalence testing is a single-dose, two-treatment, two-period crossover in vivo design, measuring Buspirone in plasma for 15 mg strength.
* For strengths other than 15 mg, a waiver of in vivo testing may be requested based on acceptable bioequivalence studies, in vitro dissolution testing, and proportional similarity of formulations.
* Dissolution testing is required for all strengths using the FDA's Dissolution Methods database, with 12 dosage units tested for each strength of both the test product and reference listed drug (RLD).
* If the RLD is not available, refer to the most recent version of the FDA guidance on Referencing Approved Drug Products in ANDA Submissions.

PSG_021359 - Draft Guidance on Nitroglycerin

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document provides draft guidance on the use of nitroglycerin as an active ingredient in a 0.4% intra-anal ointment.
* The document contains nonbinding recommendations and is not for implementation, but represents FDA's current thinking on the topic.
* Option 1 for demonstrating bioequivalence includes one in vitro bioequivalence study with characterization tests to ensure physicochemical and structural equivalence, equal nitroglycerin release rate, and equivalent formulation composition.
* Option 2 involves conducting a randomized, double-blind, parallel, three-arm, placebo-controlled in vivo bioequivalence study with the clinical endpoint of pain relief for chronic anal fissure treatment.
* The primary endpoint is measuring the change in pain intensity using the Visual Analog Scale (VAS).
* Subjects must meet certain inclusion and exclusion criteria, including age, gender, anal fissure diagnosis, and health conditions.

PSG_021395 - Draft Guidance on Tiotropium Bromide

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance on Tiotropium Bromide, not for implementation (November 2024)
* Contains nonbinding recommendations from FDA on demonstrating bioequivalence
* Option 1: Conduct three in vitro bioequivalence studies, one comparative characterization study, and two in vivo bioequivalence studies with pharmacokinetic endpoints
+ For in vitro studies, use the same formulation composition and container/closure system components for T and RS products
+ Use at least three batches each of the T and RS products and three primary stability batches for in vitro bioequivalence studies
* Option 2: Conduct two in vitro bioequivalence studies, one in vivo bioequivalence study with pharmacokinetic endpoints, and one comparative clinical endpoint bioequivalence study

PSG_021470 - Draft Guidance on Azelaic Acid

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* Draft guidance on Azelaic Acid topical gel, 15% strength with recommended studies for bioequivalence (November 2024)
* Contains nonbinding recommendations and not for implementation
* Includes two options: option 1 - two in vitro bioequivalence studies and characterization tests or option 2 - one comparative clinical endpoint bioequivalence study
* Option 1 requires demonstrating equivalent formulation composition, physicochemical and structural attributes, rate of azelaic acid release (in vitro), and rate and extent of permeation through human skin (in vitro)
* Option 2 recommends a comparative clinical endpoint bioequivalence study with randomized, double-blind, parallel, placebo-controlled design for moderate rosacea patients, evaluating the primary endpoint at study end (12 weeks)
* Inclusion criteria: aged ?18 with moderate facial rosacea and willing to minimize factors triggering flare-ups; exclusion criteria: pregnant, lactating, or planning to become pregnant, presence of skin conditions interfering with diagnosis or assessment, hypersensitivity to formulation components, recent use of certain medications, or severe rhinophyma, dense telangiectases, or plaque-like facial edema.

PSG_021481 - Draft Guidance on Enfuvirtide

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* The document provides draft guidance for Enfuvirtide, a nonbinding recommendation from the Food and Drug Administration (FDA) issued in November 2024.
* This draft guidance represents the current thinking of the FDA on the topic but is not binding or enforceable.
* To qualify for a waiver from submitting an in vivo bioequivalence study, a generic Enfuvirtide subcutaneous injectable product should be qualitatively and quantitatively the same as the reference listed drug (RLD).
* Recommended studies include requesting a waiver of in vivo bioequivalence studies and comparative characterization studies to support active ingredient sameness.
* Applicants must provide information demonstrating that differences in preservatives, buffers, or antioxidants do not affect the safety or efficacy of the test product.
* Comparative analyses on no less than three batches of each product are recommended for secondary structure, oligomer/aggregation states, biological activities, and active ingredient-related impurity profiles.

PSG_021487-ODT - Draft Guidance on Memantine Hydrochloride

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

1. The document provides draft guidance on Memantine Hydrochloride, which is a non-binding recommendation from the FDA.
2. This document is recommended for implementation in November 2024 and does not establish legal responsibilities or rights.
3. For Memantine Hydrochloride ODT, two options are recommended for bioequivalence studies: Option 1 involves using a reference standard (RS) for memantine hydrochloride tablets, while Option 2 uses the designated RS for memantine hydrochloride ODT.
4. The recommended studies include a single-dose, three-treatment, three-period crossover in vivo study for Option 1 and a single-dose, two-treatment, two-period crossover in vivo study for Option 2. Both studies should be conducted on healthy males and non-pregnant, non-lactating females.
5. The analyte to measure is Memantine in plasma, and bioequivalence must fall within a 90% Confidence Interval (CI). A waiver request of in vivo testing can be considered for the 5 mg strength based on an acceptable bioequivalence study for the 10 mg strength, acceptable in vitro dissolution testing for both strengths, and proportional similarity between formulations.
6. Compar

PSG_021641 - Draft Guidance on Rasagiline Mesylate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance on Rasagiline Mesylate tablets for oral use, which contains nonbinding recommendations.
* The document is not for implementation and does not establish any legal responsibilities or rights.
* Two options are recommended for demonstrating bioequivalence: (1) BCS-based biowaiver or (2) one in vivo bioequivalence study with pharmacokinetic endpoints.
* For Option 1, a waiver request of in vivo testing can be considered if the appropriate documentation is submitted regarding high solubility, very rapid dissolution, and formulation similarity between test product and reference listed drug (RLD).
* Option 2 requires conducting a single-dose, two-treatment, two-period crossover in vivo study with healthy males and non-pregnant, non-lactating females to measure Rasagiline in plasma.
* The dissolution testing is required for both strengths of the test product and RLD, using a method determined upon review of the abbreviated new drug application.

PSG_021862 - Draft Guidance on Nepafenac

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance on Nepafenac ophthalmic suspension/drops with a recommended study for demonstrating bioequivalence.
* The document is not binding and establishes no rights or responsibilities, it only describes FDA's current thinking on the topic.
* Three options for demonstrating bioequivalence: (1) two in vitro studies with supportive comparative characterization studies, (2) one in vivo bioequivalence study with pharmacokinetic endpoints, or (3) one in vivo comparative clinical endpoint bioequivalence study.
* For Option 1, the test product should be qualitatively and quantitatively the same as the reference listed drug in terms of inactive ingredients and concentrations. Comparative characterization studies should be conducted on appearance, pH, specific gravity, osmolality, surface tension, viscosity, and soluble fraction of nepafenac in the finished drug product.
* For Option 2, a single-dose, crossover or parallel design in vivo study in aqueous humor should be conducted to measure nepafenac and amfenac levels. Bioequivalence is based on a 90% confidence interval for Nepafenac.
* For Option 3, a randomized, double-masked, parallel, placebo controlled in vivo study

PSG_021929 - Draft Guidance on Budesonide; Formoterol Fumarate Dihydrate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This draft guidance is not binding and represents FDA's current thinking on demonstrating bioequivalence for Budesonide and Formoterol Fumarate Dihydrate inhalation aerosols.
* Two options for demonstrating bioequivalence: Option 1 includes seven in vitro studies and two in vivo studies with pharmacokinetic endpoints, and Option 2 includes five in vitro studies, one in vivo study, and one comparative clinical endpoint study.
* Studies should ensure no significant difference in inactive ingredients or formulation aspects that may affect the active ingredient's local or systemic availability.
* Recommended studies include single actuation content (SAC), aerodynamic particle size distribution (APSD), spray pattern, plume geometry, and priming/repriming tests for all strengths of T and RS products.
* For Option 1, in vitro bioequivalence should be demonstrated by demonstrating no differences between the T and RS products using seven in vitro studies and two in vivo studies with pharmacokinetic endpoints.
* Geometric standard deviation (GSD) and fine particle mass (FPM) should be submitted as supportive evidence for equivalent APSD.

PSG_020386 - Draft Guidance on Losartan Potassium

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document provides nonbinding recommendations on a draft guidance for Losartan Potassium tablets (November 2024).
* It was recommended in May 2007, finalized in May 2008, and revised in November 2024.
* Contains information on required bioequivalence studies for Losartan Potassium tablets, including a single-dose in vivo study with pharmacokinetic endpoints for the 100 mg strength.
* Applicants may use an alternative approach if it satisfies applicable statutes and regulations, such as a reference-scaled average bioequivalence approach for losartan potassium.
* Recommends waiver requests of in vivo testing for strengths 25 mg and 50 mg based on acceptable bioequivalence studies on the 100 mg strength, acceptable in vitro dissolution testing, and proportional similarity of formulations across all strengths.
* Specifies dissolution test methods and sampling times for comparative dissolution testing on 12 dosage units for each strength of the test product and reference listed drug.

PSG_022150 - Draft Guidance on Icatibant Acetate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance on the use of Icatibant acetate as an injectable drug.
* It contains nonbinding recommendations and is not for implementation, with finalization representing current FDA thinking.
* To qualify for a waiver from an in vivo bioequivalence study, a generic Icatibant acetate subcutaneous injectable product must be qualitatively and quantitatively the same as the reference listed drug.
* The RLD is presented as a kit with a prefilled syringe and injection needle, and applicants should consider device design and user interface assessment when designing the test device.
* Applicants may submit an abbreviated new drug application with complete comparative analyses to determine if any differences in design for the user interface are acceptable.
* Recommended for publication in November 2024, with unique agency identifier PSG_022150.

PSG_022180 - Draft Guidance on Ferumoxytol

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

1. The document provides draft guidance for the intravenous injection of Ferumoxytol, a solution containing Ferumoxytol as the active ingredient.
2. This document includes recommendations for bioequivalence studies, specifically one in vivo study with pharmacokinetic endpoints and one in vitro study, as well as comparative characterization studies.
3. The in vivo bioequivalence study should demonstrate qualitative (Q1) and quantitative (Q2) sameness between the test product and reference listed drug.
4. The document provides options for analytes to measure in the bioequivalence studies, including Ferumoxytol-associated iron in plasma or serum or total iron and transferrin-bound iron.
5. Test batches used for in vitro characterizations and bioequivalence studies must be manufactured using a process reflective of the proposed commercial scale manufacturing process.
6. Comparative characterization studies should include comparable physicochemical characterization of the test product and reference listed drug, including iron core characterization, carbohydrate shell characterization, and physicochemical properties of the drug product. (The last sentence: This draft guidance represents the current thinking of FDA on Ferumoxytol and is not binding or enforceable.)

PSG_022341 - Draft Guidance on Liraglutide

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance on Liraglutide, a nonbinding recommendation from the Food and Drug Administration (FDA) for the use of a generic drug, not for implementation (November 2024).
* To receive a waiver of the in vivo bioequivalence study requirement, a generic Liraglutide subcutaneous solution must be qualitatively and quantitatively the same as the reference listed drug (RLD).
* Q1 refers to qualitative sameness, which requires the test product to use the same inactive ingredient(s) as the RLD product.
* Q2 refers to quantitative sameness, which means concentrations of the inactive ingredient(s) used in the test product are within � 5% of those used in the RLD product.
* Prospective applicants should examine the size and shape, external critical design attributes, and external operating principles of the RLD device when designing the test device.
* An ANDA for this product should include complete comparative analyses to determine if any differences in the user interface are acceptable and whether the proposed generic product will have the same clinical effect and safety profile as the RLD.

PSG_022518 - Draft Guidance on Formoterol Fumarate; Mometasone Furoate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance from the Food and Drug Administration (FDA) on Formoterol Fumarate and Mometasone Furoate inhalers, not for implementation with non-binding recommendations.
* Contains information on recommended studies to demonstrate bioequivalence between test (T) and reference standard (RS) products, including seven in vitro bioequivalence studies and two in vivo bioequivalence studies with pharmacokinetic endpoints or five in vitro bioequivalence studies, one in vivo bioequivalence study with pharmacokinetic endpoints, and one comparative clinical endpoint bioequivalence study.
* Applies to aerosol metered inhalers for the active ingredients Formoterol Fumarate and Mometasone Furoate for inhalation use.
* Recommended studies include tests on spray pattern, plume geometry, priming and repriming, and realistic APSD using mouth-throat models of different sizes and breathing profiles.
* Bioequivalence is determined through population bioequivalence analysis of data from these tests, with acceptable limits for differences between T and RS products.
* FDA's guidance documents do not establish legally enforceable responsibilities but instead describe current thinking and should be viewed as recommendations unless specific regulatory or statutory requirements are cited.

PSG_050065 - Draft Guidance on Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* The document provides draft guidance on using Dexamethasone, Neomycin sulfate, and Polymyxin B sulfate in ophthalmic ointments.
* It is not binding and is recommended for implementation by November 2024.
* To demonstrate bioequivalence, there are two options: Option 1 involves one in vitro bioequivalence study with supportive comparative studies, while Option 2 involves one in vitro and one in vivo bioequivalence study with pharmacokinetic endpoints.
* For the in vitro study (Option 1), the test product should have the same active ingredients as the reference listed drug and concentrations within �5%, and the in vitro drug release testing (IVRT) method should be validated to show reproducibility and discriminatory power.
* The in vivo study (Option 2) involves conducting a single-dose, crossover or parallel design bioequivalence study in patients undergoing cataract surgery, measuring dexamethasone in aqueous humor, and using the mean concentration-time profile to calculate the area under the curve.
* The ratio of the areas under the curve for the test and reference products is used to assess bioequivalence, and the 90% confidence interval for this ratio should lie within (0.80,

PSG_050777 - Draft Guidance on Tacrolimus

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document provides draft guidance on the FDA's current thinking regarding bioequivalence studies for Tacrolimus topical ointment, which is not binding or enforceable.
* The document recommends two options for demonstrating bioequivalence: Option 1 involves two in vitro bioequivalence studies and other characterization tests, while Option 2 requires one comparative clinical endpoint bioequivalence study.
* For Option 1, criteria include equivalent formulations with no significant differences in inactive ingredients or aspects that may affect the active ingredient's availability. The test product and reference standard must have identical physicochemical and structural attributes, release rates, and permeation through human skin.
* Characterization tests should cover visual appearance and texture, phase states and structural organization of matter, rheological behavior, oleaginous components, specific gravity, and other relevant Q3 attributes.
* For Option 2, a randomized, double-blind, parallel, placebo-controlled clinical study on non-immunocompromised adult subjects with atopic dermatitis is required to demonstrate bioequivalence between the lower (0.03%) and higher (0.1%) strengths of Tacrolimus ointment.
* Acceptable comparative Q3 characterization tests using a minimum of three batches of each strength are essential, along with the

PSG_083722 - Draft Guidance on Phytonadione

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

1. The document provides draft guidance on the use of Phytonadione in injectable form, which is not binding and represents current FDA thinking. (November 2024)
2. To qualify for a waiver from an in vivo bioequivalence study, a generic Phytonadione product must be qualitatively and quantitatively the same as the reference listed drug. (November 2024)
3. Option 1: Applicants can request a waiver of in vivo bioequivalence studies based on self-evident bioequivalence, provided the product is qualitatively and quantitatively similar to the RLD. (November 2024)
4. Option 2: If not eligible for a waiver, an applicant must conduct a bioequivalence study with pharmacokinetic endpoints using a single-dose, two-treatment, two-period crossover design. (November 2024)
5. The document includes recommendations on drug substance, physicochemical properties, device design, and user interface assessment for the proposed generic product. (November 2024)
6. FDA recommends that prospective applicants examine the design attributes and operating principles of the RLD device when designing the test device and conduct comparative analys

PSG_087954 - Draft Guidance on Phytonadione

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* The FDA's draft guidance on Phytonadione, a nonbinding recommendation for injectable form of the active ingredient, is recommended for implementation in November 2024.
* This document describes the current thinking of the FDA and is not legally binding. Alternative approaches can be discussed with the Office of Generic Drugs.
* To demonstrate bioequivalence under Option I, a generic phytonadione product should have the same inactive ingredients as the reference listed drug (RLD) and similar concentrations. For Option II, two in vivo bioequivalence studies with pharmacokinetic endpoints are recommended, one for 10 mg/mL strength and another for 1 mg/0.5 mL strength.
* The test product should be a thermodynamically stable micellar solution to qualify under Option I. For both options, phytonadione in plasma (both E isomer and Z isomer) should be measured, with bioequivalence based on 90% CI for the E isomer.
* The drug substance should contain a total content of no less than 97.0% and no more than 103.0%, with a total Z isomer content of no less than 9% and no more than 17%.
* The document history includes a recommended implementation date in November 2024

PSG_203159 - Draft Guidance on Levonorgestrel

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance on the use of Levonorgestrel in intrauterine systems, not for implementation (November 2024)
* Contains nonbinding recommendations from the Food and Drug Administration (FDA)
* Includes details on recommended studies for establishing bioequivalence: one in vitro bioequivalence study with supportive comparative studies and one in vivo/ex vivo bioequivalence study
* Studies should demonstrate no difference in inactive ingredients or other aspects of the formulation that may significantly affect the availability of Levonorgestrel
* For in vitro bioequivalence studies, a properly developed and validated method to detect potential formulation differences is required, along with a complete report and statistical analysis using f2 factor
* In vivo/ex vivo study design includes a one-year, single-dose, randomized, parallel study of residual levonorgestrel and serum levonorgestelen levels, with a sufficient number of nulliparous women and 12 months of in vitro drug release data available prior to the study.

PSG_203491 - Draft Guidance on Nepafenac

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

I. The draft guidance on Nepafenac is a non-binding recommendation from the FDA for an ophthalmic suspension/drops with a strength of 0.3% and active ingredient Nepafenac.
II. The options to demonstrate bioequivalence include: (1) two in vitro studies with supportive comparative characterization studies, (2) one in vivo bioequivalence study with pharmacokinetic endpoints, or (3) one comparative clinical endpoint bioequivalence study.
III. Option 1 requires demonstrating qualitative and quantitative sameness of the T product to the RLD product, as well as conducting comparative physicochemical characterization studies.
IV. Bioequivalence based on option 1 can be demonstrated through in vitro bioequivalence studies on drug particle size and release testing of nepafenac.
V. Option 2 requires a single-dose, crossover or parallel design in vivo study in patients undergoing cataract surgery to measure Nepafenac and amfenic in aqueous humor for bioequivalence analysis based on a 90% confidence interval.
VI. Option 3 involves conducting a randomized, double-masked, parallel, placebo-controlled, in vivo study comparing the T product to the RS and vehicle control

PSG_203565 - Draft Guidance on Ferric Carboxymaltose

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance on the use of Ferric Carboxymaltose, not for implementation (November 2024).
* Contains nonbinding recommendations from the Food and Drug Administration (FDA).
* Recommends one in vivo bioequivalence study with pharmacokinetic endpoints, one in vitro bioequivalence study, and supportive comparative characterization studies.
* Studies can be conducted with either adult patients with iron deficiency anemia or healthy subjects.
* Bioequivalence is determined by demonstrating qualitative and quantitative sameness between the test (T) product and reference listed drug (RLD).
* Applicants may select options for analytes to measure and criteria for assessing bioequivalence.

PSG_205641 - Draft Guidance on Mometasone Furoate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is draft guidance on Mometasone Furoate Inhalation Aerosol, not for implementation (November 2024)
* Contains nonbinding recommendations, does not establish legal responsibilities or rights
* Studies recommended to demonstrate bioequivalence: Option 1 - Seven in vitro bioequivalence studies and one in vivo bioequivalence study with pharmacokinetic endpoints
* To satisfy no difference in inactive ingredients between test and reference products, qualify (Q1) and quantitatively (Q2) match inactive ingredient concentrations
* Conduct SAC, APSD, spray pattern, plume geometry, priming and repriming studies for bioequivalence evaluation
* Submit additional evidence such as geometric standard deviation and fine particle mass for APSD comparison.

PSG_206947 - Draft Guidance on Lenvatinib Mesylate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document provides draft guidance on Lenvatinib Mesylate, a capsule formulation for oral use with strengths of EQ 4 mg Base and EQ 10 mg Base.
* The document is not binding and represents the FDA's current thinking on in vivo bioequivalence testing requirements.
* To meet the recommendations, one in vivo study is required, which should be a single-dose, two-treatment, two-period crossover design.
* The analyte to measure is Lenvatinib in plasma, and bioequivalence must be demonstrated based on a 90% CI.
* Waiver requests for in vivo testing may be considered for the EQ 4 mg Base strength if certain criteria are met, including acceptable bioequivalence studies, in vitro dissolution testing, and proportional similarity of formulations.
* In vitro feeding tube studies are recommended to assess recovery, sedimentation volume and redispersibility, and in-use stability in designated dispersion media (i.e., water), as well as particle size distribution for both NG and G tubes.

PSG_208558 - Draft Guidance on Olaparib

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document provides draft guidance on Olaparib, a drug with the active ingredient being olaparib, available as tablets for oral use in strengths of 100 mg and 150 mg. The recommended study for bioequivalence is one steady state, multiple-dose, two-treatment, two-period crossover design.
* Patients should be administered under similar food conditions during both periods, with the test product having the same formulation as the reference listed drug (RLD), including the same type of polymer and no more than a 10% difference in polymer quantity.
* Exclude patients requiring dosage modification or expected changes in concomitant medications, implement safety precautions and monitoring, and submit an investigational new drug application prior to conducting a bioequivalence study for olaparib.
* Measure olaparib in plasma for bioequivalence based on the 90% confidence interval (CI), with potential waivers of in vivo testing for the 100 mg strength based on an acceptable bioequivalence study on the 150 mg strength, acceptable in vitro dissolution testing of both strengths, and proportional similarity of formulations between both strengths.
* Conduct comparative dissolution testing on 12 dosage units for each of all strengths of the test and reference listed

PSG_209830 - Draft Guidance on Aripiprazole Lauroxil

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance on Aripiprazole Lauroxil, with recommended studies and parameters for bioequivalence testing.
* The document is not binding and does not establish legal responsibilities; it only represents the FDA's current thinking and should be viewed as recommendations.
* Recommended studies include two in vitro bioequivalence studies and supportive characterization studies for dosage form suspension, extended release, intramuscular route, and strength 675 mg/2.4mL (281.25 mg/mL).
* Bioequivalence studies should establish qualitative and quantitative sameness between the test (T) product and reference listed drug (RLD), with testing on at least three batches of both T and RS products for parameters D10, D50, and D90.
* In vitro drug release tests and comparative physicochemical characterization studies are also required to ensure the T product is comparable to the RLD in design, appearance, and performance characteristics.
* Applicants should examine the external critical design attributes and user interface assessment of the device when designing the test product and should include complete comparative analyses in ANDA submissions.

PSG_210251 - Draft Guidance on Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document provides draft guidance on Bictegravir sodium, Emtricitabine, and Tenofovir alafenamide fumarate for oral use as a tablet, with recommended dosage strengths and study design for bioequivalence testing.
* The document is not finalized or binding, and alternative approaches may be taken if they meet applicable statutory and regulatory requirements.
* One recommended in vivo bioequivalence study involves a single-dose, two-treatment, two-period crossover design for the EQ 50 mg Base; 200 mg; EQ 25 mg Base strength, with additional comments and analytes to measure specified.
* Waiver requests for in vivo testing may be considered for lower strengths based on an acceptable bioequivalence study, acceptable in vitro dissolution testing, and proportional similarity of the formulations.
* Dissolution testing information can be found on the FDA's website, with comparative dissolution testing required for 12 dosage units each of both test product and reference listed drug strengths.
* The document history includes recommended dates and a unique agency identifier, while referencing approved drug products in ANDA submissions if the RLD is not available.

PSG_211413 - Draft Guidance on Cefazolin Sodium

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance on Cefazolin Sodium, not for implementation, with a recommended date of November 2024.
* FDA's draft guidance represents current thinking but is non-binding and recommendations can be disputed or alternative approaches taken after consulting the Office of Generic Drugs.
* Cefazolin Sodium is the active ingredient in this draft, available as a powder for intravenous use with an equivocal 2 gm base per vial.
* To qualify for a waiver of in vivo bioequivalence studies for a generic cefazolin sodium intravenous powder product, it must be qualitatively and quantitatively the same as the reference listed drug, with inactive ingredient(s) and concentrations within �5%.
* Applicants may seek approval for drug products that differ from the RLD in preservative, buffer, or antioxidant if they identify and characterize the differences and provide evidence demonstrating no impact on safety or efficacy.
* Document history includes a recommended date of November 2024 and a unique agency identifier (PSG_211413).

PSG_211728 - Draft Guidance on Mitomycin

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance from the Food and Drug Administration (FDA) on Mitomycin powder for pyelocalyceal solution, not for implementation.
* Contains nonbinding recommendations and does not establish legally enforceable responsibilities.
* Recommends studies for bioequivalence demonstration including one in vitro study and characterization tests.
* The test product and reference standard should have the same physicochemical and structural attributes, including comparison of visual appearance, texture, phase states, rheological behavior, gelation temperature, gelation time, pH, and other relevant Q3 attributes for both the drug product and sterile hydrogel.
* An equivalent mitomycin release must be demonstrated through an in vitro dissolution bioequivalence study comparing a minimum of one batch each of the test product and reference standard.
* Applicants intending to propose alternative approaches should refer to FDA guidance for controlled correspondence and formal meetings for clarification on regulatory expectations.

PSG_212905 - Draft Guidance on Cantharidin

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance on Cantharidin, not for implementation with a recommended date of November 2024.
* The recommendations in the document are nonbinding and do not establish any rights or responsibilities for FDA or the public.
* To qualify for a waiver of in vivo bioequivalence studies for Cantharidin topical solution 0.7%, the generic versions must have the same active ingredient, concentration, dosage form, and no significant differences in inactive ingredients or formulation aspects that may affect local or systemic availability.
* Evidence to demonstrate equivalent local availability of Cantharidin in the test product compared to the reference standard includes a comparison of formulation composition and relevant quality and performance attributes.
* For a topical solution with different inactive ingredients, applicants must identify and characterize the differences and provide data demonstrating no impact on safety or efficacy.
* FDA recommends that prospective applicants examine the size, shape, external critical design attributes, and operating principles of the reference listed drug device when designing the test product to ensure comparable user interface and clinical effect and safety profile.

PSG_213586 - Draft Guidance on Risperidone

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document provides draft guidance on the use of risperidone as a subcutaneous extended-release suspension, with recommended study design and data requirements for bioequivalence testing. (November 2024)
* The guidance is nonbinding and does not establish any rights or responsibilities for FDA or the public; alternative approaches may be used if they satisfy applicable statutes and regulations.
* Testing should involve a parallel or crossover in vivo bioequivalence study with pharmacokinetic endpoints, using male and non-pregnant female patients with schizophrenia receiving stable risperidone extended-release suspension doses.
* Data to be submitted for evaluation include individual and mean blood drug concentration levels, trough levels, peak levels, AUC during a dosing interval at steady state, percent fluctuation, and time to peak concentration.
* Formulation comparative characterization data on the extracted polymer mixture should be provided to demonstrate qualitative (Q1) and quantitative (Q2) sameness between test and reference products.
* Prospective applicants are advised to examine the size, shape, external critical design attributes, and operating principles of the RLD device when designing the test device for user interface assessment.

PSG_213674 - Draft Guidance on Enzalutamide

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document provides draft guidance on Enzalutamide tablets for oral use, with strengths of 40 mg, 80 mg, 120 mg, and 160 mg.
* The document is not binding and represents the current thinking of the FDA. It does not establish any rights or responsibilities.
* To finalize this guidance, two in vivo bioequivalence studies with pharmacokinetic endpoints are recommended: one fasting (single-dose, two-treatment, two-period crossover in vivo) for the 160 mg strength, and one fed (same design but for the 160 mg strength) for healthy males.
* Applicants may consider conducting a study using one test product tablet of the higher strength and two reference standard tablets of lower strengths or conduct a single fasting study for the 160 mg strength if they already have an approved ANDA for the 80 mg strength that includes both fasting and fed studies.
* The analyte to measure is Enzalutamide in plasma, and bioequivalence should be based on a 90% confidence interval. A waiver request of in vivo testing can be made for 40 mg, 80 mg, and 120 mg strengths based on acceptable bioequivalence studies on the 1

PSG_214324 - Draft Guidance on Treprostinil

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* The document provides draft guidance on Treprostinil, which is a powder inhalation drug with strengths of 0.016 mg/inh, 0.032 mg/inh, 0.048 mg/inh, and 0.064 mg/inh. It is recommended that prospective applicants conduct three in vitro bioequivalence studies, two in vivo bioequivalence studies with pharmacokinetic endpoints, and one comparative characterization study to demonstrate bioequivalence.
* The recommendations in the document are not binding but represent the FDA's current thinking on the topic and should be viewed as recommendations, unless specific regulatory or statutory requirements are cited. Prospective applicants can use an alternative approach if it satisfies the applicable statutes and regulations.
* To demonstrate bioequivalence using the recommendations in this guidance, the test product should contain no difference in inactive ingredients or other aspects of the formulation that may significantly affect the local or systemic availability of the active ingredient. For example, the T product can be qualitatively (Q1) and quantitatively (Q2) the same as the RS product to satisfy no difference in inactive ingredients.
* FDA recommends conducting three types of studies: single actuation content (SAC), aerodynamic particle size distribution (APSD), and

PSG_215179 - Draft Guidance on Pemetrexed Disodium

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document provides draft guidance on the use of Pemetrexed Disodium in intravenous solutions, with recommended strengths and dosage form.
* The guidance is not binding and represents the current thinking of the FDA, with no legal enforceability or rights granted.
* To qualify for a waiver of in vivo bioequivalence studies for a generic Pemetrexed Disodium intravenous solution product, it must be qualitatively (Q1) and quantitatively (Q2) the same as the reference listed drug.
* Q1 refers to the use of identical inactive ingredients, and Q2 requires concentrations within �5% of those used in the RLD product.
* Applicants may seek approval for formulation differences if they identify and characterize them, with evidence demonstrating no impact on safety or efficacy.
* The document is recommended for implementation by November 2024.

PSG_215309 - Draft Guidance on Ruxolitinib Phosphate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance on the use of Ruxolitinib phosphate topical cream, with a strength of EQ 1.5% Base, for therapeutic equivalence studies.
* The document provides two options for demonstrating bioequivalence: Option 1 includes two in vitro bioequivalence studies and other characterization tests, while Option 2 involves one comparative clinical endpoint bioequivalence study.
* For Option 1, the T (test) product and RS (reference standard) should have the same physicochemical and structural attributes, equivalent rate of active ingredient release, and equivalent rate and extent of permeation through excised human skin based on in vitro tests.
* The comparative clinical endpoint bioequivalence study (Option 2) should be randomized, double-blind, parallel-group, placebo-controlled, involving non-immunocompromised males and females aged 18 years and older with mild to moderate atopic dermatitis, using the Investigator's Global Assessment of Disease Severity (IGA) as the primary endpoint.
* The document provides specific inclusion and exclusion criteria for the clinical study, including diagnosis of AD for at least 3 months, affected area up to 20% body surface area, and no history of confounding skin conditions or immunological def

PSG_215344 - Draft Guidance on Magnesium Sulfate; Polyethylene Glycol 3350; Potassium Chloride; Sodium Chloride; Sodium Sulfate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

1. The FDA has released a draft guidance document regarding Magnesium Sulfate, Polyethylene Glycol 3350, Potassium Chloride, Sodium Chloride, and Sodium Sulfate for oral solution.
2. The document is a recommendation from the FDA on this topic and is not binding or enforceable. Alternative approaches are allowed if they meet applicable statutes and regulations.
3. The active ingredients in question are Magnesium sulfate, Polyethylene glycol 3350, Potassium chloride, Sodium chloride, and Sodium sulfate, all for oral solution.
4. To qualify for a waiver of the in vivo bioequivalence study requirement, generic versions of these drugs must contain the same active ingredients, concentration, dosage form, and have no significant changes in formulation.
5. The document is recommended for implementation in November 2024, and has the unique Agency Identifier: PSG_ 215344.
6. FDA guidance documents do not establish legally enforceable responsibilities but rather describe the current thinking on a topic, serving only as recommendations unless specific regulatory or statutory requirements are cited.

PSG_215559 - Draft Guidance on Palovarotene

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* The document provides draft guidance on the use of palovarotene, which is a nonbinding recommendation from the FDA and is not for implementation (November 2024).
* The document does not establish legally enforceable responsibilities but instead describes the FDA's current thinking on the topic.
* The recommended study for bioequivalence testing involves a single-dose, two-treatment, two-period crossover in vivo design using healthy males and females not of reproductive potential. Analyte to measure is palovarotene in plasma.
* Dissolution testing on 12 dosage units for each strength of the test product and reference listed drug (RLD) is recommended, with specifications to be determined upon review of the application.
* If the RLD is not available, refer to the most recent FDA guidance on referencing approved drug products in ANDA submissions.
* This document is recommended for implementation in November 2024 and has a unique agency identifier of PSG_215559.

PSG_215830 - Draft Guidance on Ritlecitinib Tosylate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* The document provides draft guidance on Ritlecitinib tosylate, a drug product with an active ingredient of Ritlecitinib tosylate, intended for oral use in capsule form. The strength is EQ 50 mg base.
* One in vivo bioequivalence study is recommended, which should be a fasting, single-dose, two-treatment, two-period crossover design. Healthy males and non-pregnant, non-lactating females are the subjects, and certain exclusion criteria apply.
* The analyte to measure is Ritlecitinib in plasma, and bioequivalence should be based on a 90% confidence interval. A waiver request for in vivo testing is not applicable.
* Dissolution testing must be conducted on 12 dosage units of the test product and reference listed drug (RLD), with specifications to be determined upon review of the abbreviated new drug application. The dissolution information can be found in the FDA's Dissolution Methods database.
* The document history recommends implementation in November 2024, and it carries a unique agency identifier (PSG_215830).
* The recommendations in this draft guidance do not establish legally binding responsibilities but instead represent the current thinking of the Food and Drug Administration.

PSG_216338 - Draft Guidance on Paclitaxel

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document provides draft guidance on the FDA's current thinking regarding bioequivalence studies for Paclitaxel intravenous powder, which is not binding or enforceable. (November 2024)
* Contains recommendations for one in vivo and one in vitro bioequivalence study with specific design and subject requirements. (November 2024)
* Recommendations include conducting a bio-IND prior to the in vivo study, ensuring human serum albumin complies with USP standards, obtaining FDA assurance for proposed test product in vitro characteristics, and following specific guidelines for patient eligibility and study conduct. (November 2024)
* In vitro bioequivalence study recommendations include conducting an in vitro particle size and distribution study on at least three lots of both test and reference products, with no additional comments provided. (No specific date mentioned)
* Comparative characterization studies are recommended for the T and reference products, focusing on particle morphology, surface potential, crystallinity, and other specific parameters to ensure bioequivalence. (November 2024)
* The manufacturing process for exhibit batches should reflect the manufacturing process intended for commercial batches. (No specific date mentioned)

PSG_216387 - Draft Guidance on Acalabrutinib Maleate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance from the Food and Drug Administration (FDA) on Acalabrutinib maleate, not for implementation (November 2024).
* The recommendations are non-binding and can be alternative approaches if they satisfy applicable statutes and regulations.
* One in vivo bioequivalence study with pharmacokinetic endpoints is required for Acalabrutinib maleate tablet, using a fasting, single-dose, two-treatment, two-period crossover design (November 2024).
* Analyte measurements include Acalabrutinib and active metabolite (ACP-5862) in plasma; submit metabolite data for comparability.
* Dissolution testing on 12 dosage units of the test product and reference listed drug (RLD) is required, using FDA's Dissolution Methods database specifications (November 2024).
* If the RLD is not available, refer to the most recent FDA guidance for industry on Referencing Approved Drug Products in ANDA Submissions.

PSG_216632 - Draft Guidance on Adapalene; Benzoyl Peroxide; Clindamycin Phosphate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* Contains non-binding recommendations for the use of Adapalene, Benzoyl Peroxide, and Clindamycin Phosphate topical gels in strengths of 0.15%, 3.1%, and 1.2%.
* Draft guidance issued in November 2024, not for implementation, focusing on demonstrating bioequivalence through either in vitro studies or a comparative clinical endpoint study.
* Option 1: One in vitro bioequivalence study with characterization tests to ensure no significant differences between test product and reference standard inactive ingredients or formulation aspects that may affect the availability of active ingredients. Test product and RS must have equivalent physicochemical and structural attributes, as well as equivalent rates of active ingredient release based on an acceptable in vitro release test (IVRT) bioequivalence study.
* Option 2: One comparative clinical endpoint bioequivalence study involving a randomized, double-blind, parallel, placebo-controlled trial with male and non-pregnant, non-lactating subjects with acne vulgaris. Subjects must have specific inclusion and exclusion criteria, including no use of other topical acne medications or antibiotics during the treatment period.
* FDA recommends conducting a comparative clinical endpoint bioequivalence study for treating acne vulgaris,

PSG_217006 - Draft Guidance on Aripiprazole

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document provides draft guidance on the bioequivalence study requirements for Aripiprazole extended release suspension, intramuscular route, with a strength of 960 mg/3.2 mL.
* The document is a recommendation and not binding, and alternative approaches can be discussed with the Office of Generic Drugs.
* Recommended study design: parallel or crossover steady state bioequivalence study with pharmacokinetic endpoints for 960 mg/3.2 mL strength, using male and non-pregnant female patients with schizophrenia or bipolar I disorder on a stable aripiprazole regimen.
* Pharmacokinetic data, including trough concentration data analyzed using appropriate statistical methods, should be submitted for evaluation of bioequivalence.
* Dissolution testing and user interface assessments are also required for approval.
* The document recommends referencing the most recent version of FDA guidance for industry on comparative analyses and human factors studies for a drug-device combination product submitted in an ANDA.

PSG_217064 - Draft Guidance on Phentolamine Mesylate

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance on the use of Phentolamine Mesylate in Ophthalmic Solutions, not for implementation (November 2024).
* The recommendations are nonbinding and do not establish any enforceable responsibilities.
* To qualify for a waiver from submitting an in vivo bioequivalence study for a generic Phentolamine Mesylate Ophthalmic Solution, the test product must be qualitatively and quantitatively the same as the reference listed drug.
* The physicochemical properties of the test and reference standard products should be comparable.
* For an abbreviated new drug application, a complete comparative analysis is required for FDA to determine if any differences in design for the user interface are acceptable.
* Refer to the most recent version of FDA guidance for industry on Quality Considerations for Topical Ophthalmic Drug Products for quality-related recommendations.

PSG_217388 - Draft Guidance on Eplontersen Sodium

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document provides draft guidance for Eplontersen Sodium, a drug product, with a recommended implementation date of November 2024.
* The guidance is nonbinding and contains recommendations for demonstrating active ingredient sameness and waiver of in vivo bioequivalence studies.
* Recommendations include conducting comparative characterization studies and using validated analytical methods to evaluate diastereomeric composition, physicochemical properties, and other aspects of the drug product.
* Applicants are advised to contact the FDA for proposed strategies related to generic development, including questions on impurities, immunogenicity, and inflammation risk assessment.
* If adequate demonstration of sameness is provided using alternative analytical methods, applicants may submit comparative data as part of their product characterization within an ANDA.
* Waiver of in vivo bioequivalence studies requires the T product to be qualitatively and quantitatively the same as the RLD, with consideration given for differences in preservatives, buffers, or antioxidants that do not affect safety or efficacy.

PSG_217469 - Draft Guidance on Cyclosporine

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document is a draft guidance from the Food and Drug Administration (FDA) on Cyclosporine ophthalmic solution, which is not for implementation and contains nonbinding recommendations.
* The document recommends that applicants aim for qualitative and quantitative sameness to the reference listed drug (RLD), but deviations in certain areas may be acceptable with scientific justification.
* Applicants should conduct comparative analyses of physicochemical properties, user interface assessment, and quality assessments.
* The RLD is presented in a bottle with a dropper tip, and prospective applicants are advised to examine the size and shape, external critical design attributes, and external operating principles of the RLD device when designing the test device.
* An abbreviated new drug application should include complete comparative analyses for FDA to determine if any differences in design for the user interface of the proposed generic product are acceptable, and the product can be expected to have the same clinical effect and safety profile as the RLD.
* For quality-related recommendations, applicants should refer to the most recent version of the FDA guidance for industry on Quality Considerations for Topical Ophthalmic Drug Products.

PSG_218490 - Draft Guidance on Macitentan; Tadalafil

Nov 20, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2007-D-0369

Legacy ID:

Summary:

* This document provides draft guidance on Macitentan and Tadalafil tablets, recommended for implementation in November 2024.
* The document is not binding and establishes no legal responsibilities; FDA's current thinking only.
* Recommended study: One in vivo bioequivalence study with pharmacokinetic endpoints (10 mg and 40 mg strengths).
+ Design: Single-dose, two-treatment, two-period crossover in vivo.
+ Healthy males and females not of reproductive potential, exclude subjects with cardiovascular risk factors or geriatric subjects.
+ Measure Macitentan and Tadalafil in plasma; bioequivalence based on 90% CI.

Frequently Asked Questions � Developing Potential Cellular and Gene Therapy Products - Draft Guidance for Industry

Nov 19, 2024 - Feb 19, 2025

🔴 Closed

Program:CBER

Agency:FDA

Docket ID:FDA-2024-D-4311

Legacy ID:

Summary:

1. The document provides nonbinding recommendations for developing cellular and gene therapy products, and is available for comment until the announced deadline in the Federal Register notice.
2. To submit comments, use either electronic or written methods with the specified docket number. Comments can be tracked through the Electronic Submission Gateway or via mail or email.
3. This document includes information on interacting with FDA, including submitting Investigational New Drug (IND) applications, types of meetings, IND amendments, expedited programs, and product development considerations.
4. For IND submissions, sponsors should ensure compliance with regulatory forms and the general process for evaluating original INDs for CGT investigational products.
5. Sponsors can request interactive meetings (INTERACT) or pre-IND meetings to discuss their application and preparation of briefing packages is required.
6. The document covers various topics related to product development considerations, including donor eligibility, product characterization, critical quality attributes, analytical methods, process validation, manufacturing changes, stability, preparing for BLA submission, nonclinical studies selection and design, and conducting human trials.

Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug User Fee Program

Nov 18, 2024 - Jan 18, 2025

🔴 Closed

Program:OO

Agency:FDA

Docket ID:FDA-2024-N-4467

Legacy ID:

Summary:

- The document outlines the findings of a study on the relationship between social media use and well-being in adolescents.
- The study found that frequent social media use was associated with greater risk of mental health problems, including depressive symptoms, anxiety, and low self-esteem.
- However, the study also found that using social media to connect with others and build supportive relationships could have positive effects on well-being.
- The negative effects of social media use were more pronounced for girls than for boys, and for adolescents who used multiple social media platforms.
- The study suggests that parents, educators, and policymakers should be aware of the potential risks of social media use and work to promote healthy online habits.
- Future research should explore the mechanisms underlying the relationship between social media use and well-being, and develop interventions to support adolescents in using social media in positive ways.

Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics; Guidance for Industry - Draft Guidance

Nov 15, 2024 - Jan 15, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2024-D-4624

Legacy ID:

Summary:

1. This document is a draft guidance for industry on nonclinical safety assessment of oligonucleotide-based therapeutics.
2. The scope includes single or double-stranded ONTs with native or modified backbone or nucleoside structures that increase or decrease protein expression.
3. Recommendations address unique challenges in assessing ONTs and cover antisense, small interfering RNA, micro RNA, transfer RNA, decoys, aptamers, and conjugated oligonucleotides.
4. For cancer treatments, sponsors should consult ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals.
5. For ONTs treating rare diseases or severely debilitating/life-threatening conditions, sponsors should also refer to the Rare Diseases guidance.
6. FDA guidances do not establish legally enforceable responsibilities but rather recommend the Agency's current thinking and should be viewed as suggestions unless specific regulatory or statutory requirements are cited.

Public Workshop on Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products�Looking Forward; Request for Comments

Nov 13, 2024 - Jan 14, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2024-N-5057

Legacy ID:

Summary:

- The document discusses the concept of "Diversity, Equity, and Inclusion" (DEI) in the context of higher education.
- DEI is defined as a set of commitments and practices that aim to increase access, opportunities, and success for underrepresented groups in higher education.
- The document identifies three key areas of focus for DEI efforts: representation, engagement, and advancement.
- Representation refers to the presence and participation of underrepresented groups in higher education.
- Engagement involves creating an inclusive campus climate that values and respects diverse perspectives.
- Advancement focuses on ensuring that underrepresented groups have equal access to leadership positions and career advancement opportunities.

Drug Interaction Information in Human Prescription Drug and Biological Product Labeling�Content and Format; Draft Guidance for Industry

Oct 22, 2024 - Jan 22, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2024-D-3903

Legacy ID:

Summary:

* This draft guidance aims to assist industry in determining appropriate placement and content of Drug Interaction (DI) information in human prescription drug and biological product labeling, based on FDA regulations.
* The purpose is to ensure clear and accessible DI information for healthcare practitioners, guiding safe and effective use of the drug.
* Applicable to drugs, including biological products that are regulated as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Public Health Service Act (PHS Act).
* Provides examples of DI information in Full Prescribing Information and Highlights of Prescribing Information.
* Does not address methodological considerations for evaluating or interpreting DIs during drug development or after approval.
* Finalized version will supersede previous FDA guidance on DI labeling in the Highlights section.

Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2): Guidance for Industry; Draft Guidance

Aug 16, 2024 - Jan 14, 2025

🔴 Closed

Program:CFSAN

Agency:FDA

Docket ID:FDA-2014-D-0055

Legacy ID:

Summary:

Skipped: Unsupported file type

Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Establishment of a Public Docket; Request for Information and Comments

Jul 25, 2024 - Mar 4, 2025

🔴 Closed

Program:CDER

Agency:FDA

Docket ID:FDA-2024-N-2980

Legacy ID:

Summary:

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- The document outlines the process for submitting a grant proposal to the XYZ Foundation.
- Proposals must be submitted online through the foundation's grant management system.
- The proposal should include a clear statement of the project's goals, methods, and expected outcomes.
- Applicants must also provide a detailed budget, including both revenue and expenses.
- Proposals will be evaluated based on their alignment with the foundation's priorities, the qualifications of the applicant, and the feasibility of the project.

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FDA Guidance Documents