美国仿制药用户付费制度8月18日会议纪要.pdfVIP

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