The Prescription Drug User Fee Act (PDUFA VI) was first created in response to a bottleneck of new medicine approvals that left patients waiting for years for an under-staffed and under-funded U.S. Food and Drug Administration (FDA or Agency) to review new drug applications. Before PDUFA, it often took the FDA more than two years to review new medicines, and more than 70 percent of medicines were first approved outside of the United States.

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