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.

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Product Reviews

More from Pink Sheet

EU’s Life Sciences Strategy Faces Race Against Time, Says Clinical Trials Community

 
• By 

The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.

Quotable: Top Experts On Policy Hot Topics

 

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Leqembi Facing 15% Price Cut In Japan

 
• By 

Japan looks set to press ahead with a reimbursement price cut for Eisai's Alzheimer's drug Leqembi following a cost-effectiveness review, despite differences with the company over methodology.