FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies
Wed, 30 Sep 2009 11:31:00 -0500

The U.S. Food and Drug Administration today announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics.

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