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US FDA’s New Voucher Fee Reveals Standard, Priority Review Cost Spike

 
• By Derrick Gingery

The number of standard and priority reviews also decreased significantly in FY 2023 compared to the previous year, which caused the fee for redeeming a voucher to rise.

increasing costs
The FDA's cost to review NME NDAs and BLAs in FY 2023 was the second-highest total since FY 2009. • Source: Shutterstock

Hidden behind the nearly doubling of the user fee to redeem a priority review voucher was a substantial decline in novel application assessments and an increase in assessment costs.

Key Takeaways

  • The FY 2025 FDA priority review voucher user fee increased 89% compared to the previous year.

  • Standard and priority novel application assessments fell significantly in FY 2023, which likely helped push the fee higher

The

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