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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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.
The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.