USFDA’s User Fee Programs - PDUFA/MDUFA/GDUFA/BsUFA/ADUFA/AGDUFA

The User Fee programs help the Food and Drug Administration (FDA) to fulfill its mission of protecting the public health and accelerating innovation in the industry. The Office of Financial Management (OFM) is responsible for the financial management of the user fee programs.

US FDA’s User Fee programs help FDA to hire and retain sufficient numbers and types of technical and scientific experts to   efficiently conduct reviews of drug/device applications and improving the predictability of review processes.

FDA’s User Fee programs

PDUFA - Prescription Drug User Fee Act

MDUFA - Medical Device User Fee Act

GDUFA - Generic Drug User Fee Act

BsUFA - Biosimilar User Fee Act

ADUFA – Animal Drug User Fee Act

AGDUFA – Animal Generic Drug User Fee Act