REMS Assessment Review Goals, Resources On The Table For PDUFA VII
US FDA proposes formal performance metrics for REMS assessment reviews, which would be part of a larger campaign to streamline the REMS assessment process.
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The prototype pulls information from the electronic record to fill out enrollment and other forms, but stakeholders say it must work for most, if not all, REMS drugs in order to be widely used.
US FDA will incorporate performance goals for reviewing REMS methodological approaches and study protocols as part of PDUFA reauthorization.
Proposed commitment letter language included a look at eliminating REMS, potentially to more clearly outline the process.