BsUFA IV: Fiscal Years 2028-2032

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

The Committee will discuss new drug application (NDA) 215244, for elamipretide hydrochloride injection, submitted by Stealth BioTherapeutics Inc., for the treatment of Barth Syndrome.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Innovative drugs often mean new treatment options for patients and advances in health care for the American public.

Innovative drugs often mean new treatment options for patients and advances in health care for the American public.

FDA Drug Alerts and Statements