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Practice Tip: FDA Issues Draft Guidance for REMS

By Alan G. Minsk and Lanchi Nguyen

On Sept. 30, 2009, the Food and Drug Administration (FDA) issued a draft guidance for industry on better understanding and implementing Risk Evaluation and Mitigation Strategies (REMS), which the FDA requires for certain drugs or biologics when the Agency believes additional precautions are necessary to ensure that the benefits of a drug or biologic outweigh its risks. The FDA is placing increased reliance on its REMS authority and, as a result, REMS assessments and implementation have placed increased demands on time, money, and resources for sponsors and for physicians and hospitals.

The draft document, Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modification (“REMS Guidance“), reveals the Agency's current thinking on the format and content that manufacturers should use in developing proposed REMS.

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