Recently Issued Guidance Documents

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• Investigational COVID-19 Convalescent Plasma; Guidance for Industry
  (Updated January 7, 2022)  CBER, January 2022

• Digital Health Technologies for Remote Data Acquisition in Clinical Investigations - Guidance for Industry, Investigators, and Other Stakeholders; Draft Guidance for Industry
  CDER/CBER/CDRH/OCE, December 2021

• Inspection of Injectable Products for Visible Particulates; Draft Guidance for Industry
  CDER/CBER/CVM, December 2021

• Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency; Guidance for Industry and Health Professionals
  CBER, December 2021

• Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment; Draft Guidance for Industry
  CDER/CBER, December 2021

• Development of Anti-Infective Drug Products for the Pediatric Population; Guidance for Industry
  CDER/CBER, December 2021

• Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry
  CDER/CBER, December 2021

• CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports; Guidance for Industry
  CDER/CBER, December 2021

• Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry; Draft Guidance for Industry
  CDER/CBER/OCE, November 2021

• Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments:  Questions and Answers; Guidance for Industry
  CBER, November 2021

• Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry
  CDER/CBER, October 2021

• Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide; Guidance for Industry
  CDER/CBER/CVM, October 2021

• Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Draft Guidance for Industry
  CDER/CBER, October 2021

• Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Guidance for Industry
  CBER/OOPD, September 2021

• Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Draft Guidance for Industry
  CBER, September 2021

• Benefit-Risk Assessment for New Drug and Biological Products; Draft Guidance for Industry
  CDER/CBER, September 2021

• Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry
  CDER/CBER/CDRH, September 2021

• Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry
  CDER/CBER/OCE, September 2021

• Questions and Answers on Biosimilar Development and the BPCI Act; Guidance for Industry
  CDER/CBER, September 2021

• New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3); Draft Guidance for Industry
  CDER/CBER, September 2021

• ICH Q12: Implementation Considerations for FDA-Regulated Products; Draft Guidance for Industry
  CDER/CBER/CDRH, September 2021

• Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency; Guidance for Industry, Investigators, and Institutional Review Boards
  CDER/CBER/CDRH/OC, August 2021

• Notifying FDA of Fatalities Related to Blood Collection or Transfusion; Guidance for Industry
  (Updated August 20, 2021) CBER, August 2021

• FDA Export Certification; Guidance for Industry
  CDER/CBER/CDRH/CFSAN/CVM, August 2021

• Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials; Guidance for Industry
  CDER/CBER, August 2021