1. Pink Sheet

US FDA's FY 2023 User Fees Finally Revealed

 
• By Derrick Gingery

Several fees for prescription drug, generic drug, and biosimilar applications are set to increase, although some also will drop.

Fees
The new user fees were announced five days into FY 2023 after Congress did not renew the programs until 30 September. • Source: Shutterstock

Many US Food and Drug Administration user fees for drugs and biosimilars increased for fiscal year 2023, with a few notable exceptions.

The agency announced the new prescription drug, generic drug, biosimilar and priority review voucher fees on...

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