Dissecting The Rules Of Generic Drug User Fee Amendments

May 9, 2013By: Suchira Ghosh Download PDF

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.