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美国仿制药用户付费制度8月18日会议纪要
FDA-Industry Generic Drug User Fee (GDUF) Negotiations Meeting
August 18, 2011, 9:00-3:00pm
FDA White Oak Campus
Silver Spring, MD
_______________________________________________________________________
Purpose
To finalize changes to a draft letter of performance commitments and goals, discuss
operationalizing fee structures for the generic drug user fee act (GDUFA) program, and
discuss legislative language.
Participants
Generic Pharmaceutical Association (GPhA)
Debbie Jaskot (phone) Teva North America
Charlie Mayr (phone) Watson Pharmaceuticals
Marci McClintic-Coates (phone) Mylan Labs
Tom Moutvic (phone) Sagent Pharmaceuticals
Lara Ramsburg Mylan Labs
Rich Stec Perrigo
European Fine Chemicals Group (EFCG)
Carla Vozone (phone) Hovione
Bulk Pharmaceutical Task Force (BPTF) of the Society of Chemical Manufacturers
and Affiliates (SOCMA)
Alan Nicholls Copperhead Chemical Company, Inc.
Brant Zell (phone) Polypeptide Laboratories
FDA
Leslie Ball Center for Drug Evaluation and Research (CDER)
Peter Beckerman Office of the Commissioner (OC)
Lisa Berry Office of Commissioner (OC)
Hilmar Hamann Center for Drug Evaluation and Research (CDER)
Brian Hasselbalch Center for Drug Evaluation and Research (CDER)
Mike Jones Center for Drug Evaluation and Research (CDER)
Kevin Laser Center for Drug Evaluation and Research (CDER)
Mari Long Office of the Commissioner (OC)
Marie Angeline O’Shea Center for Drug Evaluation and Research (CDER)
Suzanne Pattee Center for Drug Evaluation and
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