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PDUFA V: FDA Application Completeness Crackdown Continues

Executive Summary

FDA remains firm in its push for application completeness in PDUFA V, despite its willingness to add two new review cycle meetings with sponsors.

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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.

PDUFA Communications Hurt By Sequestration As Late-Stage Meetings Begin

Twenty sponsors now have applications in the new review model, but none have reached the approval decision stage; industry officials say it still is too early to draw conclusions.

Buying Time: Industry Sacrifices Early To Gain Later With PDUFA V Review Model

NMEs and novel biologics will see reviews allotted two additional months under the revised model launching Oct. 1. Industry expects to gain more communication and first-cycle approvals, while FDA hopes it can receive more complete applications at submission and improve transparency.

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