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PDUFA V 'Program' First-Cycle Approval Rates Significantly Higher For All Applications

 
• By Sue Sutter

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.

FDA entrance sign 2016

The current FDA review model for new molecular entities and novel biologics is delivering on its promise of more first-cycle approvals and greater review efficiencies, a new analysis shows.

First-cycle approval rates for standard and priority applications, as well as total applications, reviewed under the Prescription Drug User Fee Act V "Program" are statistically significantly higher compared to a...

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