Sentinel Could Be Used For Pregnancy Safety Studies Under PDUFA VII
User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.
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US FDA will incorporate performance goals for reviewing REMS methodological approaches and study protocols as part of PDUFA reauthorization.
Sponsor representatives also want postmarketing discussions moved to earlier in the assessment cycle.
Other subgroups negotiating specific issues for the user fee reauthorization have indicated that agreements are close.