PDUFA V Reviews Are ‘Best Ever’ For Some Sponsors, Maybe Not FDA
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.’
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Sponsor-FDA Communications In IND Phase Will Get Outside Review
US FDA seeks White House approval for to contract for interviews with 100 to 150 active commercial IND holders.
User Fees: Should US FDA Incur Penalties For Missed Deadlines?
Sen. Burr asks FDA whether fee revenue should be rebated for not meeting some PDUFA V goals.
PDUFA V 'Program' First-Cycle Approval Rates Significantly Higher For All Applications
Success of review model for new molecular entities and novel biologics should bolster US FDA and industry's stance that Congress reauthorize the user fee program without tinkering with the negotiated agreement, which retains the 'Program' but builds in more flexibility.