Executive FDA Leadership Reviews & Previews PDUFA Reauthorization

The current US Prescription Drug User Fee Act, commonly referred to as PDUFA V, will sunset at the end of 2017.  At the first Public Meeting on PDUFA Reauthorization, Center for Drug Evaluation and Research Director Dr. Janet Woodcock said, “PDUFA has been generally considered successful. We continue to meet or exceed nearly all our application review goals…And these accomplishments are, in part, made possible by the resources provided by this program.” In this exclusive podcast, Dr. Woodcock and Dr. Theresa Mullin, Director of FDA’s Office of Strategic Programs, discuss PDUFA, the need for reauthorization into PDUFA VI, and its progress since the initial 1992 legislative authorization. Update: Dr. Woodcock will also share her expert regulatory insights through her Keynote Address at Advancing the Science of Study Endpoints; she will be joined by Dr. Mark McClellan, Director, Duke-Robert J. Margolis Center for Health Policy, Duke University, to share their perspectives on the development of study endpoints, Where Are We Now and Where Are We Going?