Adverse Events and Product Deviation Guidances

Should you find a link that does not work within any Guidance document, Rule or other document posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact FDA. 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Submissions in Electronic Format - Postmarketing Safety Reports for Vaccines - Guidance for Industry CBER, August 2015 Draft Guidance for Industry: Providing Submissions in Electronic Format - Postmarketing Safety Reports CDER/CBER, June 2014 Guidance for Industry: E2B(R3) Electronic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 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Section of Labeling for Human Prescription Drug and Biological Products - Content and Format CDER/CBER, January 2006 Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines CDER/CBER, March 2001 Guidance for Industry: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