For nearly 30 years, the Prescription Drug User Fee Act (PDUFA) has played a critical role in strengthening the U.S. Food and Drug Administration’s (FDA) ability to help ensure the availability of safe and effective medicines. First created in response to a bottleneck in the drug approval system that left patients waiting for years for an under-staffed and under-funded FDA to review new drug applications, PDUFA has helped meet urgent patient needs for more timely review and approval of life-saving medicines.

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.

Read more about this important legislation with this fact sheet from PhRMA.