On Sept. 22, 2022, the President signed into law the U.S. Food and Drug Administration (FDA) User Fee Reauthorization Act, which reauthorized the Prescription Drug User Fee Act of 2017 (PDUFA) and provided for the continued timely review of new drug and biologic license applications.

The PDUFA was created by Congress in 1992 and authorizes FDA to collect user fees from persons that submit certain human drug applications for review or that are named in approved applications as the sponsor of certain prescription drug products.

Since the passage of PDUFA, user fees have played an important role in expediting the drug review and approval process.