The Food and Drug Administration Reauthorization Act (FDARA), recently signed into law, includes the first reauthorization of the Generic Drug User Fee Amendments (GDUFA II). Congress enacted GDUFA in 2012 to ensure that patients have access to safe, affordable generic drugs, while also enabling FDA to assess industry user fees to cover the review of generic drug applications. The reauthorization substantially alters the fee structure of this program. In this webinar, panelists will discuss relevant aspects of FDARA and the GDUFA II Commitment Letter, highlight major changes to the program, and discuss the effects on the generics industry.
Brian R. McCormick, General Counsel, Regulatory and Lifecycle, TEVA Pharmaceuticals USA, Inc.
David Gaugh, Senior Vice President of Sciences and Regulatory Affairs, Association for Accessible Medicines
Moderated by Frederick (Rick) Ball, Partner, Duane Morris LLP, and Member, FDLI Board of Directors