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).
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).