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GUIDANCE DOCUMENT

Development and Use of Risk Minimization Action Plans Guidance for Industry March 2005

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2004-D-0441
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This document provides guidance to industry on the development, implementation, and evaluation of risk minimization action plans for prescription drug products, including biological drug products. In particular, it gives guidance on (1) initiating and designing plans called risk minimization action plans or RiskMAPs to minimize identified product risks, (2) selecting and developing tools to minimize those risks, (3) evaluating RiskMAPs and monitoring tools, and (4) communicating with FDA about RiskMAPs, and (5) the recommended components of a RiskMAP submission to FDA.

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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-0441.

 
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