Recently Issued Guidance Documents
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A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers; Guidance for Industry
CDER/CBER/CDRH/OCLiP/ORA, April 2023 -
Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
CDER/CBER/CDRH, April 2023 -
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER/CDER/OCP, April 2023 -
Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act; Draft Guidance for Industry
CDER/CBER, April 2023 -
Identification of Medicinal Products — Implementation and Use; Guidance for Industry
CDER/CBER, March 2023 -
Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, March 2023 -
Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry
CBER, August 2020 (Updated March 23, 2023) -
Pharmacogenomic Data Submissions
CDER/CBER/NCTR, March 2023 -
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Guidance for Industry
CDER/CBER, March 2023 -
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Draft Guidance for Industry
CDER/CBER/CDRH/CFSAN/CTP/CVM/ORA/OCLiP, March 2023 -
Investigational COVID-19 Convalescent Plasma; Guidance for Industry
CBER, January 2022 (Updated March 13, 2023) -
Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry
CBER, March 2022 (Updated March 13, 2023) -
Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry
CBER, June 2020 (Updated March 13, 2023) -
Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency; Guidance for Industry
CBER, April 2020 (Updated March 13, 2023) -
Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, February 2023 -
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Draft Guidance for Industry
OPT/CDER/CBER/CDRH, February 2023 -
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products; Draft Guidance for Industry
CDER/CBER, February 2023 -
VDosage and Administration Section of Labeling for Human Prescription Drug and Biological Products - Content and Format; Draft Guidance for Industry
CDER/CBER, January 2023 -
Format and Content of a REMS Document; Guidance for Industry
CDER/CBER, January 2023 -
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe; Guidance for Industry
CDER/CBER, December 2022 -
Drug Products Labeled as Homeopathic; Guidance for FDA Staff and Industry
CDER/CBER, December 2022 -
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, December 2022 -
Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry
CBER, December 2022