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FDAAA Impact Analysis (Year 3): REMS R.I.P.? Not Yet

This article was originally published in RPM Report

Executive Summary

FDA’s reconsideration of its new Risk Evaluation & Mitigation Strategy authority put the brakes on use of the new post-marketing safety tools as 2011 began, and a formal decision not to require REMS for all products with mandatory MedGuides means a significant step down in use of REMS in the future. But that doesn’t mean REMS won’t be routine in the future.

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