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

 
• By Brenda Sandburg

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

The US Food and Drug Administration’s prescription drug user fee program exceeded its collection target by more than 4% for cohort year 2021, while biosimilar user fee collections fell short by less than 1% and generic drug user fee collections were 4% less than expected.

The agency recently gave an update on the five-year financial plans of the prescription drug, biosimilar and generic drug user fee programs during a public meeting on financial transparency and...

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