REMS, Risk and Reward

REMS, or Risk Evaluation and Mitigation Strategy, is a new tool that Congress provided the FDA to ensure the safe use of certain types of prescription drug products. The 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 its risks.

23 minute read September 29, 2009 at 11:27 AM
By
Alan Minsk And Lanchi Nguyen
REMS, Risk and Reward

REMS, while not to be confused with R.E.M., the Athens, GA-based rock band, is becoming almost as ubiquitous and as influential on its respective audience.

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