Late-Cycle Approval Predictions Not A Good Idea, FDA Says
OND Director John Jenkins says the late-cycle meeting in the new PDUFA review model will offer a lot of information to sponsors, but likely will not be predictive of application approvability.
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Longer application review time has been producing the improved communication sponsors expected, but modifications to the user fee program have yet to make inspections go smoother.
Concept would allow more time for sponsors to make launch plans and could help improve communication under GDUFA.
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.