Vaccines, Blood & Biologics
Adverse Events and Product Deviation Guidances
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- Guidance for Industry: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic (PDF - 218KB)
OCET/CDER/CBER/CFSAN/CDRH, February 2012.
Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs — Improving Human Subject Protection(PDF - 61KB)
OC/CDER/CBER/CDRH/GCPP, January 2009
- Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Postmarketing Individual Case Safety Reports (PDF - 90KB)
CDER/CBER, June 2008
Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components
CBER/CDER, October 2006
- Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 52KB)
CDER/CBER, January 2006
- Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (PDF - 375KB)
CDER/CBER, March 2001
- Guidance for Industry: Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (PDF - 95KB)
CDER/CBER, August 1997