First-Cycle Approval Rate Already High; Can PDUFA V Actually Boost It?

FDA official says the rate of approving applications in the first review cycle may not increase much more, even as the new review model, intended to promote more first-cycle approvals, has yet to finish with its inaugural applications.

FDA already may be nearing the peak of its ability to approve applications during the first review cycle, less than a year into use of a new review system intended for that purpose.

The agency’s first-cycle approval rate, which measures the portion of submitted applications successfully cleared before their first user fee goal date, is so high now that FDA is wondering whether...

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