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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The FDA announced the prescription drug user fees for FY 2021 late on 29 July.

NDA and BLA sponsors received a welcome surprise late 29 July, when the US Food and Drug Administration announced that application user fees would decrease more than 2% in fiscal year 2021 compared to the current year.

Applications requiring clinical data will be more than $67,000 less, according to a Federal Register notice scheduled to be published 3 August. Applications not requiring clinical data will see a more than $33,000 fee decrease. (See table below.)

Both fees still will be higher than those in FY 2019. (Also see "PDUFA Application Fee Nears $3m Threshold In FY 2020" - Pink Sheet, 1 Aug, 2019.)

Program fees will increase more than $11,000 compared to FY 2020. All three rates will go into effect 1 October.

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