REMS, Risk, and Reward

REMS, while not to be confused with R.E.M., the Athens, Georgia-based rock and roll band, is becoming almost as ubiquitous and as influential on its respective audience. REMS, or Risk Evaluation and Mitigation Strategy, is a new tool that Congress provided the Food and Drug Administration to ensure the safe use of certain types of prescription drug products. REMS is an extension of Congress and FDA’s renewed emphasis on drug safety and proactive risk management. FDA may require a drug manufacturer to include a REMS in its new drug application when the agency concludes this is necessary to ensure that the benefits of the drug outweigh the risks of the drug.

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