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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Transfusion-Transmitted Malaria: Draft
Guidance for Industry		 2025-01-15 CBER Blood, Blood Products Draft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
Technical Specifications for Submitting
Clinical Trial Data Sets for Treatment of
Noncirrhotic Nonalcoholic Steatohepatitis
(NASH): Guidance for Industry Technical
Specifications Document		 2024-12-13 CDER Final
Guidance for Industry: Registration and
Listing of Cosmetic Product Facilities and
Products		 2024-12-11 OC\Office of the
Chief Scientist		 Final
Standardized Format for Electronic
Submission of NDA and BLA Content for the
Planning of Bioresearch Monitoring (BIMO)
Inspections for CDER Submissions Guidance
for Industry		 2024-12-06 CDER Electronic
Submissions,		 Final
Accelerated Approval – Expedited Program
for Serious Conditions		 2024-12-05 CDER Draft
CVM GFI #49 Evaluating Target Animal Safety
and Effectiveness of Antibacterial New
Animal Drugs for Bovine Mastitis		 2024-12-04 CVM Premarket, Animal
Drugs, Clinical -
Antimicrobial, Target
Animal –
Effectiveness, Target
Animal – Safety,
Investigational New
Animal Drug (INAD),
New Animal Drug
Application (NADA)		 Draft
Draft Guidance for Industry: Notifying FDA
of a Permanent Discontinuance in the
Manufacture or an Interruption of the
Manufacture of an Infant Formula		 2024-12-02 Human Foods
Program		 Infant Formula & Foods Draft
Use of Circulating Tumor Deoxyribonucleic
Acid for Early-Stage Solid Tumor Drug
Development; Guidance for Industry;
Availability		 2024-11-27 OCE Final
Assessment of Ovarian Toxicity in
Premenopausal Adults During Drug Development
for Oncologic Products		 2024-11-26 OCE; CDER; CBER Draft
Transitional Enforcement Policy for Ethylene
Oxide Sterilization Facility Changes for
Class III Devices: Guidance for Industry
and Food and Drug Administration Staff		 2024-11-26 CDRH Premarket Approval
(PMA), HUD/HDE		 Final
Orthopedic Non-Spinal Bone Plates, Screws,
and Washers - Premarket Notification
(510(k)) Submissions: Guidance for Industry
and Food and Drug Administration Staff		 2024-11-22 CDRH\Office of
Product Evaluation
and Quality\Office
of Health
Technology VI -
Orthopedic Devices		 Premarket, 510(k),
Orthopedic		 Final
Orthopedic Non-Spinal Metallic Bone Screws
and Washers - Performance Criteria for
Safety and Performance Based Pathway:
Guidance for Industry and Food and Drug
Administration Staff		 2024-11-22 CDRH Premarket, 510(k),
Orthopedic		 Final
510(k) Third Party Review Program and Third
Party Emergency Use Authorization (EUA)
Review: Guidance for Industry, Food and
Drug Administration Staff, and Third Party
Review Organizations		 2024-11-21 CDRH Premarket, 510(k),
Administrative /
Procedural		 Final
Frequently Asked Questions — Developing
Potential Cellular and Gene Therapy Products		 2024-11-18 CBER Gene Therapy,
Pediatric Product
Development		 Draft
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