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Duration: 40 min. presentation with 15 min. Q&A.
The Prescription Drug and User Fee Act (PDUFA) IV will expire in September 2012. A new version of this legislation, PDUFA V, is expected in the coming months and may have implications for your regulatory strategy and development program. Join David Shoemaker, Ph.D. as he discusses the history of PDUFA and what may be included in the upcoming version.
David Shoemaker, PhD