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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User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.
'Indirect and direct review roles' would be added with user fee funds after the PDUFA program is reauthorized.
User fee reauthorization negotiators from US FDA and industry divide into subgroups to tackle specific issues before moving to the broader agreement.