Surprise! PDUFA Fees Dropping In FY 2021
A more than 2% drop for NDAs and BLAs in FY 2021, while program fees will increase more than 3%.
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In part because assessment costs plummeted in FY 2019, the FY 2021 fee to redeem a priority review voucher will be 37% less than the previous year.
The US FDA fee for a new drug or biologics license application requiring clinical data will jump to $2.94m in October.
The agency is considering how to move forward as Pfizer studies a third shot after missing an efficacy endpoint in children age 2 to 5.