For nearly 25 years, the Prescription Drug User Fee Act (PDUFA) has provided greater consistency, certainty and predictability for the U.S. Food and Drug Administration’s (FDA) human drug review program and has helped bring safe and effective, innovative medicines to patients. Because of PDUFA, the United States now leads the world in the introduction of new medicines and the FDA human drug review program is the global gold standard for regulatory review and approval.