GDUFA Legislation

On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA).  This new law includes the Generic Drug User Fee Amendments of 2012 (GDUFA) which is designed to speed access to safe and effective generic drugs to the public.  GDUFA authorizes the Food and Drug Administration (FDA) to collect fees from drug companies that submit marketing applications for certain generic human drug applications, certain drug master files, and certain facilities.

• Generic Drug User Fee Amendments of 2012; Pub. L. 112-144, Title III
• FDA User Fee Corrections Act of 2012 signed into law Oct. 5, 2012 to enable collection of FY 2013 GDUFA user fees without enactment of an appropriations Act
• GDUFA Commitment Letter: Human Generic Drug Performance Goals and Procedures Fiscal Years 2013 through 2017