Premarketing Risk Assessment

Docket Number:: FDA-2004-D-0121
Issued by:: Guidance Issuing Office

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

This document provides guidance to industry on good risk assessment practices during the development of prescription drug products, including biological drug products. This is one of three guidances that were developed to address risk management activities. Specifically, this document discusses the generation, acquisition, analysis, and presentation of premarketing safety data.

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All written comments should be identified with this document's docket number: FDA-2004-D-0121.

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Premarketing Risk Assessment

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