PDUFA Collections Exceeded Target In FY 2021, While GDUFA Fell Short

The US FDA reports that the prescription drug user fee program met 27 of its 29 commitments by the end of FY 2021 and the biosimilar user fee program is on track to meet 16 of 27 of its performance enhancement goals.

Fees
US FDA user fee collections exceeded the revenue target for one program and fell short for two others • Source: Shutterstock

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