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In this section: Prescription Drug User Fee Amendments

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

FDA Backgrounder on FDAMA

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

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