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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Financial model is not adequate right now, FDA Commissioner Robert Califf says, so the agency may make regulatory changes to motivate sponsors.
Financial model isn't adequate currently, FDA Commissioner Robert Califf says, and agency may make regulatory changes to motivate sponsors.
US FDA will incorporate performance goals for reviewing REMS methodological approaches and study protocols as part of PDUFA reauthorization.