Recently Issued Guidance Documents

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• Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers; Guidance for Industry
  CDER/CBER/CDRH/CVM/CFSAN/CTP/ORA, May 2023

• Study Data Technical Conformance Guide - Technical Specifications Document; Guidance for Industry
  CDER/CBER, May 2023

• Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information; Draft Guidance for Industry
  CDER/CBER, May 2023

• Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Draft Guidance for Industry
  CDER/CBER, May 2023

• Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act; Draft Guidance for Industry
  CDER/CBER, May 2023

• Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components; Guidance for Industry
  CBER, May 2023

• Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry
  CBER, May 2023

• Decentralized Clinical Trials for Drugs, Biological Products, and Devices; Draft Guidance for Industry, Investigators, and Other Stakeholders
  CDER/CBER/CDRH/OCE, May 2023

• 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Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders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Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff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in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act; Draft Guidance for Industry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

• 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