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

This article was originally published in RPM Report

Executive Summary

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.

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