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Prescription Drugs User FeesInternet URLhttp://www.fda.gov/oc/pdufa/reports.html
Sponsoring AgencyU.S. Food and Drug Administration DescriptionThe Prescription Drug User Fee Act (PDUFA) of 1992 provided FDA with increasing levels of resources for the review of human drug applications. Fees that FDA collected from drug and biologics firms from 1993 to 1997 were to be used to reduce the time required to evaluate certain human drug applications without compromising review quality. FDA has submitted annual Performance and Financial Reports to Congress on progress in streamlining the drug review process and use of PDUFA fees. The original act expired Sept. 30, 1997, but the FDA Modernization Act of 1997 amended and extended PDUFA through Sept. 30, 2002. The amended act is now referred to as PDUFA II and its predecessor as PDUFA I.
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