PDUFA Application Fee Nears $3m Threshold In FY 2020
The US FDA fee for a new drug or biologics license application requiring clinical data will jump to $2.94m in October.
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But the agency chose to fund only a small fraction of them, in part because of its hiring ability, and in part because all those employees would have cost an additional $98.7m in user fee revenue.
A more than 2% drop for NDAs and BLAs in FY 2021, while program fees will increase more than 3%.