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GUIDANCE DOCUMENT

Premarketing Risk Assessment Guidance for Industry March 2005

Download the Final Guidance Document Read the Federal Register Notice
Final
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.2 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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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-2004-D-0121.

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