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Food and Drug Administration / Sleep / Sleep medicine / Xyrem / Fibromyalgia / Gamma-Hydroxybutyric acid / Center for Drug Evaluation and Research / Medicine / Health / Pharmacology


U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may
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City

Munich / Bethesda / /

Company

D. / Scientific Affairs Jazz Pharmaceuticals Inc. / Coast Medical Group / Jazz Pharmaceuticals / Compliance Officer Jazz Pharmaceuticals Inc. / Hertz / Clinical Development / D. Chief Medical Officer Jazz Pharmaceutical Inc. / M.D. / Psychopharmacologic Drugs Advisory Committee Industry / /

Event

FDA Phase / /

Facility

University Clinical Research Center The University of Texas Health Science Center / Sansum Clinic / /

IndustryTerm

marketed product / healthcare system / diagnostic tools / diagnostic tool / /

MedicalCondition

fibromyalgia / fibromyalgia population / pain / /

MedicalTreatment

medication errors / /

OperatingSystem

OSE / /

Organization

office of Biostatistics / office of Drug Evaluation / M.S. Statistical Reviewer Division / Voting Committee / office of Surveillance and Epidemiology / Arthritis Advisory Committee / New Leaf Treatment Center / FDA REMS / Risk Management Advisory Committee / M.P.H. Clinical Team Leader Division of Anesthesia / Division of Risk Management / Division of Neurology Products / Drug Safety and Risk Management Advisory Committee / Arthritis Drugs Advisory Committee / U.S. Food and Drug Administration / National Fibromyalgia Association / Analgesia Products / Center for Clinical Rheumatology Practice for Internal Medicine and Rheumatology Munich-Graefelfing / FDA Lunch Break Open Public Hearing Committee Discussion and Voting Committee / University of Texas Health Science Center at San Antonio / M.P.H. Clinical Team Leader Division of Anesthesia and Analgesia Products / /

Person

Arthritis Advisory / Mark Fletcher / Thomas Kosten / Mary Willy / Kellie Taylor / Neil / Ted Mikuls / Sheldon Kapen / Yasmin Choudhry / Sidney Wolfe / William Z. Potter / Richard Denisco / Linda Zeman / Barbara Berney / Muhammed B. Yunus / David E. Blumenthal / Jan Mathies / Anuja Patel / Deanna Power / Karen T. Albach / Jennifer E. Wilson / Cynthia Morris-Kukowski / Lynn Matallana / Diane Guinta / Robert Stine / Gregory Backes / Annette Madrid / Diane Aronson / Nancy Olsen / Alex Stalcup / Perspectives Michael Spaeth / Rita Ann Campbell / Robert Kerns / Jennie Blauvelt / Elaine Morrato / Ellen Fields / P.H. FDA / Sharon Hertz / Richard Meisch / Victor Rosenfeld / Susan Christ / Charles Rohde / David Petullo / John Markman / Christy Sandborg / Henry Francis / Lenore Buckley / Mary Ellen Olbrisch / Dennis Dixon / Opening Remarks Ellen Fields / Lewis Nelson / Evan F. Ekman / Jeffrey E. Kirsch / Need Jon Russell / William Cooper / Bob Rappaport / Barbara Gehr / /

Position

Vice President / Designated Federal Official / physician / Chair Committee / Federal Official / Director Division of Medication Error Prevention and Analysis / MPH Designated Federal Officer / Professor of Medicine Director / dispensing pharmacist / Chair / Medical Officer / Representative / Introduction Janne Wissel Chief / Specialist / /

Product

FDA Medication / Xyrem / Yasmin / Ph.D. Drug / /

ProvinceOrState

Texas / Maryland / /

URL

http /

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