Zdrowie i gospodarka · 10.07.1998
Prescription Drug User Fee Act, ``PDUFA II Five-Year Plan;'' Availability
The Food and Drug Administration (FDA) is announcing the availability of an internal planning document entitled ``PDUFA II Five- Year Plan.'' This plan is intended to show FDA's anticipated prescription drug user fee revenues and planned expenditures of the fee revenues over the 5-year period from 1998 through 2002. The plan is designed to assist in achieving 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 (FDAMA). The amended and extended PDUFA is referred to as PDUFA II.