FDA Guidance: Development and Use of Risk Minimization Action Plans

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Overview:

This 27-page PDF 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, this paper 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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