Adverse Events and Product Deviation Guidances

Return to General Biologics Guidances

 

|2011 | 2009 | 2008 | 2006 | 2001 | 1997 |

Title	Organization(s)	Date
2011
Draft Guidance for Industry: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic  (PDF - 246KB)  (This guidance revises the draft guidance of the same title published in December 2008)	OCET/CDER/CBER/CFSAN/CDRH	January 2011
2009
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
2008
Draft Guidance for Industry: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic  (PDF - 246KB)	OCET/CDER/CBER/CFSAN/CDRH	December 2008
Draft Guidance for Industry:Providing Regulatory Submissions in Electronic Format – Postmarketing Individual Case Safety Reports (PDF - 107KB)	CDER/CBER	June 2008
2006
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
2001
Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines  (PDF - 375KB)	CDER/CBER	March 2001
1997
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