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FDAAA Impact Analysis (Year 5): The REMS Paradox

This article was originally published in RPM Report

Executive Summary

FDA is approving new molecules at the fastest rate of the REMS era, while actually imposing REMS obligations less frequently than ever. That is good news for sponsors—but it doesn’t make a lot of sense if the REMS are working as intended. After five years, the role of REMS is still very much a work in progress.

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