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The REMS Era Begins: FDA Applies Soft Touch With New Drug Safety Tools

This article was originally published in RPM Report

Executive Summary

Congress gave FDA some tough new tools to regulate drugs in September, but no one could know for sure how FDA would use them. Now there is some actual real world experience to judge by: a half-dozen drugs approved by FDA are subject to either a Risk Evaluation & Mitiagation Strategy or a mandatory post-marketing commitment. So far, the news is good for drug developers.

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

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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