Theravance / INDUSTRY PRESENTATIONS Develco Pharma Schweiz AG / Head Clinical Project Management Develco Pharma Schweiz AG / Regulatory Nonclinical Cubist Pharmaceuticals Inc. / Salix Pharmaceuticals Inc. / PhD Pharmacology Theravance Inc. / MD Clarifying Questions BREAK INDUSTRY PRESENTATION Theravance Inc. / Hertz / Clinical Research Cubist Pharmaceuticals Inc. / Regulatory Affairs Cubist Pharmaceuticals Inc. / BREAK INDUSTRY PRESENTATION - COLLABORATIVE Clarifying Questions INDUSTRY PRESENTATIONS Cubist Pharmaceuticals Inc. / AstraZeneca / PharmD / PhD Associate / DPM / DABT / /
Event
FDA Phase / Product Recall / Product Issues / /
Facility
Clinical Research Florida International University Herbert Wertheim College / FDA White Oak Campus / White Oak Conference Center / Medicine University of Colorado Denver Clarifying Questions INDUSTRY PRESENTATION / /
office of Drug Evaluation / office of New Drugs / Food and Drug Administration / office of Surveillance / University of Colorado / Anesthetic and Analgesic Drug Products Advisory Committee / Food and Drug Administration Center for Drug Evaluation / Safety Outcomes Acting Team Leader Division / Medicine University / Medicare / MPH Chairperson / Florida International University / Division of Gastroenterology and Inborn Errors Products / FDA / Division of Analgesia / Anesthesia and Addiction Products / Information Office / Center for Drug Evaluation and Research / Advisory Committee / /
Person
David Madigan / Sukhminder K. Sandhu / Helmut H. Albrecht / Cynthia Wong / Mark Sostek / Kate Lane / Anne Burnett Tandy / James Ramsay / Mary Parks / Solomon Iyasu / Sonia Hernandez-Diaz / Susan Krivacic / Clara Y. Kim / Milton Packer / Peter W. F. Wilson / Steven Solga / Marvin A. Konstam / Charles W. Emala Sr. / Rafael V. Miguel / Timothy O. Lipman / Richard L. Leff / Craig Paterson / David S. Craig / Brendan M. Everett / Robert P. Fiorentino / Jennifer G. Higgins / Gary A. Walco / Randall Flick (Chairperson) / Mu-Opioid Antagonists Donna Griebel / William Mezzanotte / Michael Proschan / Tobias Gerhard / Alan D. Kaye / Randall P. Flick / Brian T. Bateman / Mitchell S. Cappell / John R. Teerlink / Sharon Hertz / H. Ware / Julie Beitz / Oral Naloxone / Stephanie L. Begansky / Linda A. Feagins / Lee Techner / Pamela Golden / Molecular Pharmacology / William P. Forbes / Jennifer Liscouski / Vesna Jevtovic-Todorovic / Gavril Pasternack / Mori Krantz / Henry R. Kranzler / Axelopran David Beattie / Ursula Wesselmann / Donna Griebel / Randall Flick / William B. White / /
Position
Neurology and Laboratory Head / Development and Chief Development Officer / Vice President Nonclinical and Clinical Pharmacology Clinical Review / Professor and Chair / Vice President / speaker / Vice President Medical and Clinical Development / Federal Officer / Professor / Director / Executive Vice President / Chairperson / Representative / Designated Federal Officer / Medical Team Leader / Biology and Pharmacology Associate Dean for Clinical Research / MPH Chair / Lead Mathematical Statistician Division of Biometrics / /
Food and Drug Administration Center for Drug Evaluation and Research Summary Minutes of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting June 11-12, 2014 Location: The FDA White Oak Campus, Building