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• Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Draft Guidance for Industry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

• Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry
  CBER, January 2023 (Updated March 13, 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• Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment; Draft Guidance for Industry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• Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Draft Guidance for Industry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• Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products; Draft Guidance for Industry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

• Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry
  CBER, January 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and Administration Section of Labeling for Human Prescription Drug and Biological Products – Content and Format; Draft Guidance for Industry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• Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff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

• Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Guidance for Industry
  CBER, November 2022

• Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, November 2022

• Cross Labeling Oncology Drugs in Combination Regimens; Guidance for Industry
  CDER/CBER/OCE, November 2022

• Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Guidance for Industry
  CBER, November 2022

• Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Draft Guidance for Industry
  CDER/CBER/OCLiP/OCE, November 2022

• Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Small Entity Compliance Guide; Guidance for Industry
  CBER, November 2022

• Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry
  CDER/CBER, November 2022