The Prescription Drug User Fee Act (PDUFA) of 1992 provided FDA with greater resources for the review of human drug and biologic applications. Fees that FDA collected from drug and biologics firms were used to reduce the time required to evaluate 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 September 30, 1997, but the FDA Modernization Act of 1997 amended and extended PDUFA through September 30, 2000. The amended act is now referred to as PDUFA II and its predecessor as PDUFA I.
EXPECTED DATE OF COMPLETION:09/30/2001
AGENCY SPONSOR: Food and Drug Administration
FEDERAL CONTACT: Dennis Hill, 301-827-5255
PIC ID: 6079.6
PERFORMER: Office of Policy, Planning, and Legislation, FDA, Rockville MD