Recently Issued Guidance Documents

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• 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• New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3); Draft Guidance for Industry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• ICH Q12: Implementation Considerations for FDA-Regulated Products; Draft Guidance for Industry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

• 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

• Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI); Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER July 2021

• Field Alert Report Submission: Questions and Answers; Guidance for Industry
  CDER/CBER, July 2021

• Providing Regulatory Submissions in Alternate Electronic Format; Guidance for Industry
  CDER/CBER, July 2021

• Evaluating Cancer Drugs in Patients with Central Nervous System Metastases; Guidance for Industry
  OCE/CDER/CBER, July 2021

• Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies; Draft Guidance for Industry
  CDER/CBER, June 2021

• Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings; Draft Guidance for Industry
  OCE/CDER/CBER, June 2021

• Premenopausal Women with Breast Cancer: Developing Drugs for Treatment; Guidance for Industry
  OCE/CDER/CBER, June 2021

• Providing Regulatory Submissions in Electronic Format - Standardized Study Data; Guidance for Industry
  CDER/CBER, June 2021

• Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry
  CBER/CDER, June 2021

• Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, June 2021

• Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Guidance for Industry
  CDER/CBER, June 2021

• Enhanced Drug Distribution Security at the Package Level under the Drug Supply Chain Security Act; Draft Guidance for Industry
  CDER/CBER, June 2021

• Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry
  CDER/CBER, June 2021

• Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry
  CDER/CBER/ORA, June 2021

• Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages, Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, May 2021

• Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry
  (Updated May 25, 2021) CBER, May 2021

• Bispecific Antibody Development Programs; Guidance for Industry
  CDER/CBER, May 2021

• Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products; Draft Guidance for Industry
  CDER/CBER, May 2021

• Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1); Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1)
  CDER/CBER/OGCP, May 2021

• Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection, and Withdrawal of Guidance titled “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components”
  CBER, May 2021

• COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers; Guidance for Industry
  CDER/CBER, March 2021

• Investigational COVID-19 Convalescent Plasma; Guidance for Industry
  (Updated February 11, 2021)  CBER, February 2021