Experts: REMS Process Likely to See Changes With PDUFA Reauthorization

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. Among the first of the casualties is likely to be the FDA’s much-maligned medication guides, which have been criticized as ineffective in educating patients about drug-related risks, David Feigal, former director of the Center for Devices and Radiological Health and now a principal with the consulting firm NDA Partners, said.
Drug Industry Daily