Adverse Events and Product Deviation Guidances

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• Providing Submissions in Electronic Format - Postmarketing Safety Reports for Vaccines - Guidance for Industry
  CBER, August 2015

• Draft Guidance for Industry: Providing Submissions in Electronic Format - Postmarketing Safety Reports
  CDER/CBER, June 2014

• Guidance for Industry: E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide - Data Elements and Message Specification (version 5.01)
  CDER/CBER, February 2014

• Guidance for Industry: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
  OCET/CDER/CBER/CFSAN/CDRH, February 2012

• Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs - Improving Human Subject Protection
  OC/CDER/CBER/CDRH/GCPP, January 2009

• Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components; Guidance for Industry
  CBER/CDER, October 2006

• Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products - Content and Format
  CDER/CBER, January 2006

• Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines
  CDER/CBER, March 2001

• Guidance for Industry: Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report
  CDER/CBER, August 1997