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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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.
While the prescription drug user fee agreement between industry and the US FDA is almost done, generic renewal talks remain ongoing, and biosimilar talks have not started.