US FDA Priority Review Voucher Fee Continues Drop In FY 2020
Executive Summary
Sponsors will pay 12% less to redeem a voucher in FY 2020, which is charged on top of the traditional PDUFA user fee.
You may also be interested in...
Priority Review Voucher Programs Poised For US Legislative Attention In 2020
Unless reauthorized by Congress, the rare pediatric disease program will begin to expire in September; renewal could bring bigger changes across the three PRV programs, including an FDA-requested clarification of biologic products eligible for vouchers and reforms suggested by sponsors and other stakeholders in a recent GAO report.
Priority Review Vouchers Post Lower Average Approval Times Than Priority NMEs
US FDA’s priority review voucher program delivers for most sponsors, a Pink Sheet analysis finds; PRVs reliably produce faster approval than priority-reviewed new drugs overall.
Everything's Special At US FDA: Priority NDA/BLA Filings Surge
The FY 2018 PDUFA performance report also indicates that applications with standard assessments fell compared to long-term averages.