PhRMA, BIO’s PDUFA V Application Tracker Could Inform “Course Corrections”
This article was originally published in The Pink Sheet Daily
Members will enter data into secure database, allowing trade groups to gauge trends and problems with the PDUFA V application review program – and giving industry a stronger negotiating position for the next user fee round.
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Data may help industry stake out its negotiating position as formal talks near for user fee reauthorization.
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.