GDUFA Paid Facilities List (May 21, 2026 15:52)
This list contains GDUFA facility payments received by the Agency. Data are extract fro...

Generic Drug User Fee Amendments (May 21, 2026 15:23)
This page features news and information for industry and stakeholders about GDUFA, its ...

Prescription Drug User Fee Amendments (May 21, 2026 14:59)
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authoriz...

Human Drug Compounding Outsourcing Facility Fees (May 21, 2026 14:58)
Human Drug Compounding Outsourcing Facility Fees

BsUFA IV: Fiscal Years 2028-2032 (May 21, 2026 13:27)
On September 30, 2022, the President signed into law the FDA User Fee Reauthorization A...

Prescription-to-Nonprescription (Rx-to-OTC) Switches (May 21, 2026 11:54)
A sponsor of a nonprescription drug product may seek to market a prescription drug prod...

Drug Application Process for Nonprescription Drugs (May 21, 2026 11:52)
There are two regulatory pathways to bring a nonprescription drug to market in the U.S....