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GUIDANCE DOCUMENT

Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report August 1997

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1997-D-0445
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The FDA has undertaken a major effort to clarify and revise its regulations regarding pre- and postmarketing safety reporting requirements for human drug and biological products. With regard to the postmarketing safety reporting regulations for human drug and licensed biological products, the Agency published a proposed rule in the Federal Register of October 27, 1994 (59 FR 54046), to amend these requirements, as well as others, to implement international standards, and to facilitate the reporting of adverse experiences. The FDA is still considering comments submitted in response to this proposed rule and will be finalizing the proposed amendments based on those comments as well as on recommendations developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and by the World Health Organization's Council for International Organizations of Medical Sciences (CIOMS).

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1997-D-0445.

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