PDUFA VI: Then, Now and The Future

The Prescription Drug User Fee Act (PDUFA) provides consistency, certainty and predictability for the U.S. FDA's human drug review program, helping to bring safe and effective medicines to patients.

Established in 1992 to address concerns about unacceptable delays in the FDA’s regulatory review of new medicines for patients, PDUFA has provided greater consistency, certainty and predictability for the FDA’s human drug review program and has helped bring over 1,500 new safe and effective innovative medicines to patients.

PDUFA is a shining example of successful public policy, and its reauthorization will support biopharmaceutical innovation and help to bring the next generation of new medicines and potential cures to patients..

Learn more at phrma.org/PDUFA