Dissecting The Rules Of Generic Drug User Fee Amendments

Law360, New York (May 9, 2013, 12:26 PM EDT) -- The Generic Drug User Fee Amendments (GDUFA), which were enacted as part of the comprehensive U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) in July 2012, changed the practice of generic drug sponsors in a multitude of ways, most notably, the requirement of various types of fees associated with the filing of an application for approval of a generic drug with the FDA.

The GDUFA also sets forth various other requirements intended to improve the efficiency and quality of the generic drug approval process....
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