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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PDUFA V: FDA Relaxes Pre-Submission Meeting Requirement
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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.