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Food and Drug Administration Center for Drug Evaluation and Research Summary Minutes of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting May 22, 2013 Location: The FDA White Oak Campus, Building
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Company

Merck / M.D. / Dohme Corp. / Worldwide Regulatory Group / /

Facility

FDA White Oak Campus / White Oak Conference Center / /

IndustryTerm

treatment of insomnia / proposed dosing algorithm / drug product / heavy machinery / drug products / /

MedicalCondition

insomnia / obesity / /

Organization

Peripheral and Central Nervous System Drugs Advisory Committee / office of New Drugs / Food and Drug Administration / Sleep Foundation / FDA / Food and Drug Administration Center for Drug Evaluation / Information Office / Center for Drug Evaluation and Research / Individual committee / Division of Neurology Products / Central Nervous System Drugs Advisory Committee / National Research Center for Women & Families / /

Person

Robert B. Voas / Sammy Almashat / Matthew Rizzo / Robert R. Clancy / David Michelson / Hristina Dimova / Russell G. Katz / Lisa M. Schwartz / Richard P. Hoffman / Remarks Russell Katz / Paul B. Rosenberg / Efficacy Ronald Farkas / Richard J. Ross / Ronald D. Chervin / Ellis Unger / Christian Guilleminault / Roger R. Rosa / Ellen J. Marder / Michelle M. Mielke / Jason W. Todd / Joseph Herring / Ronald Farkas / PCNS FDA / Glendolynn S. Johnson / Jeffrey A. Cohen / Russell Rosenberg / Suvorexant Nadine Margaretten / Psy / Natalie Compagni Portis / Emilia Bagiella / Lynn Kramer / Diana Zuckerman / Daniel G. Morrow / Justin A. Zivin / /

Position

Vice President / Clinical Research Neuroscience / Federal Officer / Executive Director / Director / Director / Clinical Research Neuroscience / physician / Cross-Discipline Team Leader / Designated Federal Officer / Representative / Chairperson / Chair / /

Product

zolpidem / /

ProvinceOrState

Maryland / /

Technology

Neuroscience / proposed dosing algorithm / /

URL

http /

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