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Guidance Title Issue Date FDA Organization Topics Status
Institutional Review Boards Frequently Asked
Questions: Guidance for Institutional
Review Boards and Clinical Investigators		 2025-02-05 OC\Office of the
Chief Medical
Officer\Office of
Clinical Policy		 Good Clinical Practice
(GCP), Pediatric
Product Development		 Final
Evaluation of Sex Differences in Clinical
Investigations: Guidance for Industry		 2025-01-20 OC\Office of the
Chief Medical
Officer\Office of
Clinical Policy		 Good Clinical Practice
(GCP)		 Final
Recommendations to Reduce the Risk of
Transfusion-Transmitted Malaria: Draft
Guidance for Industry		 2025-01-15 CBER Blood, Blood Products Draft
Premarket Approval Application and
Humanitarian Device Exemption Modular
Review: Guidance for Industry and FDA Staff		 2025-01-13 CDRH; CBER Premarket, Final
Accelerated Approval and Considerations for
Determining Whether a Confirmatory Trial is
Underway		 2025-01-07 OCE Draft
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		 2025-01-07 CDRH; CBER Postmarket, Final
Communications From Firms to Health Care
Providers Regarding Scientific Information
on Unapproved Uses of Approved/Cleared
Medical Products: Questions and Answers		 2025-01-06 CVM; CBER; CDRH;
CDER; OC		 Administrative /
Procedural		 Final
Guidance for FDA Staff and Interested
Parties: Evaluating the Public Health
Importance of Food Allergens Other Than the
Major Food Allergens Listed in the Federal
Food, Drug, and Cosmetic Act		 2025-01-06 Human Foods
Program		 Allergens, Labeling Final
Guidance for Industry: Action Levels for
Lead in Processed Food Intended for Babies
and Young Children		 2025-01-06 Human Foods
Program		 Infant Formula &
Foods, Lead		 Final
Guidance for Industry: Questions and Answers
Regarding Food Allergen Labeling (Edition 5)		 2025-01-06 Human Foods
Program		 Allergens, Labeling Final
Interim Policy on Compounding Using Bulk
Drug Substances Under Section 503A of the
Federal Food, Drug, and Cosmetic Act		 2025-01-06 CDER Administrative /
Procedural,
Compounding		 Final
Interim Policy on Compounding Using Bulk
Drug Substances Under Section 503B of the
Federal Food, Drug, and Cosmetic Act		 2025-01-06 CDER Administrative /
Procedural,
Compounding		 Final
Recommendations for Determining Eligibility
of Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps):
Draft Guidance for Industry		 2025-01-06 CBER Tissue Draft
Recommendations to Reduce the Risk of
Transmission of Hepatitis B Virus (HBV) by
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps): Draft
Guidance for Industry		 2025-01-06 CBER Hepatitis B, Tissue Draft
Recommendations to Reduce the Risk of
Transmission of Hepatitis C Virus (HCV) by
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps): Draft
Guidance for Industry		 2025-01-06 CBER Hepatitis C, Tissue Draft
Recommendations to Reduce the Risk of
Transmission of Human Immunodeficiency Virus
(HIV) by Human Cells, Tissues, and Cellular
and Tissue-Based Products (HCT/Ps): Draft
Guidance for Industry		 2025-01-06 CBER HIV/AIDS, Tissue Draft
Validation and Verification of Analytical
Testing Methods Used for Tobacco Products		 2025-01-06 CTP Final
Advanced Manufacturing Technologies
Designation Program		 2024-12-31 CBER; CDER Chemistry,
Manufacturing, and
Controls (CMC),
Pharmaceutical Quality		 Final
E11A Pediatric Extrapolation 2024-12-30 CDER; CBER ICH-Efficacy,
Pediatric Product
Development		 Final
Combined Food and Drug Administration and
Sponsor Oncologic Drugs Advisory Committee
Briefing Document		 2024-12-27 OCE Prescription Drugs,
Oncology		 Draft
Global Unique Device Identification Database
(GUDID): Guidance for Industry and Food and
Drug Administration Staff		 2024-12-17 CDRH GUDID, Labeling, UDI Final
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