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Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15 Public Meeting; Request for Comments
The Food and Drug Administration (FDA or the Agency) held a public meeting that provided an overview of the current status of the regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA is seeking this input from a variety of stakeholders––industry, academia, patient advocates, professional societies, and other interested stakeholders––as it fulfills its statutory requirement under the Generic Drug User Fee Amendments of 2012 (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public meeting into account in developing the FY 2014 Regulatory Science Plan.
Date: June 21, 2013
Time: 9:00 a.m. to 5:00 p.m.
Location: FDA White Oak Campus
10903 New Hampshire Avenue,
Bldg. 31, Room 1503 (Great Room)
Silver Spring, Maryland 2099
Agenda: Generic Drug User Fee Amendments of 2012 Regulatory Science Initiatives Part 15 Public Meeting(PDF - 55KB) Robert Lionberger, Acting Deputy Director for Science, Office of Generic Drugs, CDER, FDA(PDF - 237KB) Gordon Johnston, Generic Pharmaceutical Association(PDF - 696KB) Carla Vozone, The European Fine Chemical Group(PDF - 1.4MB) Tod Cooperman, ConsumerLab.com(PDF - 290KB) Robert Price, University of Bath, UK(PDF - 1.9MB) Peter Byron, Virginia Commonwealth University School of Pharmacy(PDF - 805KB) Guenther Hochhaus, University of Florida(PDF - 421KB) Darby Kozak & Hans van der Voorn, Izon Science US Ltd(PDF - 1.5MB) Jacqueline French, American Epilepsy Society, The Epilepsy Foundation(PDF - 200KB) Michel Berg, University of Rochester Medical Center(PDF - 180KB) Tricia Ting, University of Maryland School of Medicine(PDF - 613KB) Rita Alloway, American Society of Transplantation(PDF - 138KB) Jeremy A. Greene, Johns Hopkins Bloomberg School of Public Health(PDF - 3.3MB) Uday Kompella, University of Colorado Denver(PDF - 932KB) Stephen W. Hoag, University of Maryland School of Pharmacy(PDF - 331KB) Jim Polli, University of Maryland School of Pharmacy(PDF - 246KB)
A recording of the webcast can be found at the following (in 4 parts):
- Part 1: https://collaboration.fda.gov/p6mwx3i92u5
- Part 2: https://collaboration.fda.gov/p8w368vj2bj
- Part 3: https://collaboration.fda.gov/p8i9hw6k3bw
- Part 4: https://collaboration.fda.gov/p34q0yfxu8p