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

 
• By Michael McCaughan

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.

By Michael McCaughan

In January 2010, every single original new drug application cleared by the Food & Drug Administration included a Risk Evaluation & Mitigation Strategy. In February 2011, not a single one...

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