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Zdrowie i gospodarka · 27.08.1999

Prescription Drug User Fee Act (PDUFA) II Five-Year Plan Revision; Availability

The Food and Drug Administration (FDA) is announcing the availability of an internal planning document entitled ``PDUFA II Five- Year Plan: FY 1999 Revision.'' This revised plan updates FDA's anticipated prescription drug user fee revenues and planned expenditures of the fee revenues over the 5-year period from 1998 to 2002. The revised plan to achieve the new goals for the drug review process under the Prescription Drug User Fee Act of 1992 (PDUFA), which was amended and extended through the year 2002 by the Food and Drug Administration Modernization Act of 1997, takes into account changes in revenue projections and work load based on actual revenue and application receipts in fiscal year (FY) 1998. The amended and extended PDUFA is referred to as PDUFA II.

Source: Federal Register — Food and Drug AdministrationOpen original release →