The Prescription Drug User Fee Act (PDUFA) has helped the U.S. Food and Drug Administration (FDA or Agency) fulfill its central mission – to protect and advance public health – by allowing the Agency to keep pace with the number and complexity of innovative medicines entering the review pipeline. In large part because of PDUFA, the United States leads the world in the introduction of innovative new medicines, and the FDA’s human drug review program is the global gold standard for regulatory review and approval.

Since 1992 when the program was first enacted, PDUFA has helped enable timely access to more than 1,700 new drugs and biologics including treatments for cancer, rare diseases, cardiovascular, neurological and infectious diseases.

PDUFA continues to play a critical role in strengthening the FDA’s ability to review human drug applications. The program also provides biopharmaceutical companies with greater regulatory predictability, which fosters industry investment in research and development. At each five-year reauthorization of PDUFA, FDA and the biopharmaceutical industry can advance initiatives that further support innovation and enhance the regulatory review process and that are captured in the PDUFA goals letter.