PDUFA V: Review Model Evaluators Will Observe All FDA-Sponsor Meetings
This article was originally published in The Pink Sheet Daily
Interim and final assessments will help determine which parts of the new, longer application review help FDA take more first-cycle actions.
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FDA officials suggest allowing late-cycle meeting opt-out and question the impact of the new lengthened review system in interim assessment of the ‘Program.’
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.
Scheduling mid- and late-cycle meetings complicates reviews for FDA, but the fate of the “Program” probably depends on whether industry feels the extra two months produces better outcomes.