Recently Issued Guidance Documents

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

• Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry
  (Updated February 22, 2021) CBER, February 2021

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

• Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19); Guidance for Industry
  CDER/CBER/CVM, January 2021

• Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency; Guidance for Industry
  CBER, January 2021

• Safer Technologies Program for Medical Devices; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, January 2021

• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, January 2021

• Human Gene Therapy for Neurodegenerative Diseases; Draft Guidance for Industry
  CBER, January 2021

• Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Guidance for Industry
  CDER/CBER, December 2020

• Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Guidance for Industry
  (Updated December 17, 2020)  CBER, December 2020

• Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products; Guidance for Industry
  CBER/CDER, December 2020

• Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry
  CDER/CBER, December 2020

• Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry
  CDER/CBER, December 2020

• Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis; Guidance for Industry
  CBER, December 2020

• Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017; Guidance for Industry
  CDER/CBER, November 2020

• Qualification Process for Drug Development Tools; Guidance for Industry and FDA Staff
  CDER/CBER, November 2020

• Cross Labeling Oncology Drugs in Combination Regimens; Draft Guidance for Industry
  OCE/CDER/CBER, November 2020

• Electromagnetic Compatibility (EMC) of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, November 2020

• Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products; Guidance for Industry
  CBER/CDER, December 2020

• Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs; Guidance for Industry
  CDER/CBER, November 2020

• Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, November 2020

• Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies; Guidance for Industry
  CDER/CBER/ORA, October 2020

• Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry; Draft Guidance for Industry
  CDER/CBER, October 2020

• Testing for Biotin Interference in In Vitro Diagnostic Devices; Guidance for Industry
  CBER/CDRH, October 2020