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LJN's Product Liability Law & Strategy

March 2010

Practice Tip: FDA Issues Draft Guidance for REMS

Part One of a Two-Part Article

By Alan G. Minsk and Lanchi Nguyen

On Sept. 30, 2009, the FDA issued a draft guidance for industry on better understanding and implementing Risk Evaluation and Mitigation Strategies (REMS), which the FDA requires for certain drugs or biologics.

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