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GUIDANCE DOCUMENT

Premarketing Risk Assessment Guidance for Industry March 2005

Final

Premarketing Risk Assessment

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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.