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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REMS Integration Into Electronic Health Records To Be Tested By US FDA In Software Pilot
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.
PDUFA VII Will Fund Pregnancy Postmarket Safety Update, Sentinel Upgrades, REMS Standardization
US FDA will incorporate performance goals for reviewing REMS methodological approaches and study protocols as part of PDUFA reauthorization.
PDUFA VII Could Increase Transparency Of REMS Release Process
Proposed commitment letter language included a look at eliminating REMS, potentially to more clearly outline the process.