FDAAA Fading? REMS Use Continues To Decline As Drug Safety Law Matures

FDA’s use of REMS continues to fall to almost undetectable levels, with the agency using the safety tools just a handful of times in the sixth full year of the program. REMS are now very much the exception and not the rule for new products – but still a very important exception.

Six years into the REMS era, it is still an open question what (if any) impact Risk Evaluation & Mitigation Strategies have on reducing the risk of adverse events from prescription drugs.

However, there is one key risk that has declined sharply in the past few years: the risk that a sponsor will be required

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