US FDA Priority Review Voucher Fee Continues Drop In FY 2020
Sponsors will pay 12% less to redeem a voucher in FY 2020, which is charged on top of the traditional PDUFA user fee.
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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.
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.
The FY 2018 PDUFA performance report also indicates that applications with standard assessments fell compared to long-term averages.