Clinical Vanda Pharmaceuticals Inc. / Health Research Group / Vanda Pharmaceuticals Inc. / MD Senior Medical Director Vanda Pharmaceuticals Inc. / PhD Chief Medical Officer Vanda Pharmaceuticals Inc. / /
Event
FDA Phase / /
Facility
Sheraton Silver Spring Hotel / Cypress Ballroom / Hospital Harvard Medical School Boston / /
Association for Education and Rehabilitation / office of New Drugs / Food and Drug Administration / Biostatistics office of Translational Sciences / Food and Drug Administration Center for Drug Evaluation / American Council / Division of Neurology Products / FDA NDA / Peripheral and Central Nervous System Drugs Advisory Committee / Harvard Medical School Boston / National Organization for Rare Disorders / Blinded Veterans Association / American Foundation / Information Office / Center for Drug Evaluation and Research / /
Person
Pathophysiology Charles Czeisler / Robert R. Clancy / Safety Joseph Sliman / Efficacy Marlene Dressman / Suzanne Helen Erb / Melanie Brunson / Ellis Unger / Ellen J. Marder / Jeffrey A. Cohen / Jingyu (Julia) Luan / Lynn Kramer / Endpoints Louis Licamele / Devanand Jillapalli / Justin A. Zivin / Eric Bastings / Sammy Almashat / Pharmacology Paolo Baroldi / Cynthia Sitcov / Randy Meyer / Carl Augusto / Safety Devanand Jillapalli / Paul B. Rosenberg / Mihael H. Polymeropoulos / Thomas Zampieri / Charmane Eastman / Richard J. Kryscio / Introductory Remarks Eric Bastings / Richard P. Hoffmann / Michelle M. Mielke / Fred W. Turek / Jason W. Todd / Nathan B. Fountain (Chairperson) / Nathan B. Fountain / Ronald Farkas / PCNS FDA / Glendolynn S. Johnson / Emilia Bagiella / Michael V. Vitiello / Diane Edquist Dorman / Mark Riccobono / /
Position
Senior Director / Mathematical Statistician Division of Biometrics / Vice President / Chief Executive Officer / Patricia L. Leader / Federal Officer / Acting Director / Chairperson / Medical Officer / Representative / PharmD Designated Federal Officer / Director / /
Food and Drug Administration Center for Drug Evaluation and Research Summary Minutes of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting November 14, 2013 Location: The Sheraton Silver Spring Ho