PDUFA Legislation and Background: PDUFA II
The FDA Modernization Act of 1997, enacted on November 21, 1997, reauthorized the Prescription Drug User Fee Act of 1992 for five more years (PDUFA II).
Legislation
Background
- Letter from Donna Shalala: Goals Pertaining to the Reauthorization of the Prescription Drug User Fee Act (11/12/1997)
- Letter Enclosure: PDUFA Reauthorization Performance Goals and Procedures