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REMS Reform Looks To Be Theme Of PDUFA V: Stakeholders Call For Standardization, Earlier Notice

Executive Summary

The biggest changes that came out of the FDA Amendments Act, the last round of Prescription Drug User Fee Act reauthorization, were FDA's augmented drug safety authorities, most specifically the Risk Evaluation and Mitigation Strategy tool. Going into the next round of PDUFA negotiations, a major focus will be on improving the implementation of the REMS program

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