Question: As part of their risk management strategy for certain drugs, the Food and Drug Administration (FDA) requires a so-called “Risk Evaluation and Mitigation Strategy (REMS)”. What does a REMS include?
Answer: The noted reference states: “A REMS includes at least one of the following component: a Medication Guide, a communication plan for health care providers, and “elements to assure safe use” (ETASUs).” (Gassman AL et al. FDA regulation of prescription drugs. 2017 NEJM 376:674-682 and FDA basics webinar: a brief overview of Risk Evaluation and Mitigation Strategies (REMS). Silver Spring, MD: Food and Drug Administration, September 2, 2016 (http://www.fda.gov/AboutFDA/)
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