Practice Tip: FDA Issues Draft Guidance for REMS

On Sept. 30, 2009, the FDA issued a draft guidance for industry on better understanding and implementing Risk Evaluation and Mitigation Strategies (REMS), which the FDA requires for certain drugs or biologics.

26 minute read February 25, 2010 at 09:17 AM
By
Alan G. Minsk and Lanchi Nguyen
Practice Tip: FDA Issues Draft Guidance for REMS

On Sept. 30, 2009, the Food and Drug Administration (FDA) issued a draft guidance for industry on better understanding and implementing Risk Evaluation and Mitigation Strategies (REMS), which the FDA requires for certain drugs or biologics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

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