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Evolving Perspectives on Managing the Risks of Medical Products
October 7, 2002

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Table of Contents

Evolving Perspectives on Managing the Risks of Medical Products

Outline

PDUFA3 and Risk Management

Risk Management Guidance

Risk Management Efforts to Date

Current Risk Management Tools

Current Risk Management Tools

Current Risk Management Tools

Risk Management Examples

Example: Rezulin

Example: Accutane

Example: Mifeprex

Example: Clozapine

Risk Management Questions

Author:

Anne Trontell, M.D. M.P.H.
FDA CDER Office of Drug Safety

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FDA/Center for Drug Evaluation and Research
Last Updated: October 8, 2002
Originator: OTCOM/DLIS
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