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Home » Experts See Changes to REMS With PDUFA Reauthorization
Experts See Changes to REMS With PDUFA Reauthorization
October 29, 2010
With drugmakers urging changes to the FDA’s risk evaluation and mitigation strategies (REMS) ahead of the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA), experts are predicting that several features common to the programs could become a thing of the past.