FDA Issues Draft Guidance for Industry on Risk Evaluation and Mitigation Strategies (REMS)

On September 30, 2009, the Food and Drug Administration issued a draft guidance for industry on better understanding and implementing Risk Evaluation and Mitigation Strategies (“REMS”), which FDA requires for certain drugs or biologics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

Click the link below to read the full alert.