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FDA May Require NDA Pre-Filing Meeting Under PDUFA V Review Model; Pilot Launching Soon

Executive Summary

The new application review process being negotiated as part of the PDUFA V reauthorization is nearing the pilot stage and could require sponsors to have the bulk of their information ready before submission.

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

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PDUFA V: FDA Relaxes Pre-Submission Meeting Requirement

Sponsors may have negotiated a four-month reprieve for the required pre-submission meeting in the proposed new application review system expected to be implemented with PDUFA V.

PDUFA V: FDA Relaxes Pre-Submission Meeting Requirement

Sponsors may have negotiated a four-month reprieve for the required pre-submission meeting in the proposed new application review system expected to be implemented with PDUFA V.

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