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Pharmacology / Clinical pharmacology / Therapeutics / United States Public Health Service / Center for Drug Evaluation and Research / Tegaserod / American College of Cardiology / Food and Drug Administration / Pharmaceutical sciences / Medicine


Microsoft Word - Summary Minutes-GIDAC 17Nov2011 _signed_.doc
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City

Washington / DC / Washington / College Park / /

Company

Johnson & Johnson / BREAK Sponsor’s Presentations Theravance Inc. / HT4 Receptor Theravance Inc. / Development (J&JPRD) LLC / Established / M.D. Acting Industry / D. / /

Event

FDA Phase / /

Facility

Holiday Inn / Meeting Holiday Inn / The Ballroom / /

MedicalCondition

chronic kidney disease / gastroesophageal reflux disease / constipation / peripheral vascular disease / gastroparesis / cardiovascular disease / chronic-idiopathic constipation / predominant irritable bowel syndrome / functional motility disorders / /

Organization

Gastrointestinal Drugs Advisory Committee / office of New Drugs / Food and Drug Administration / Division of Gastroenterology and Inborn Errors Products / office of Biostatistics OTS / Center for Drug Evaluation and Research / Clinical Pharmacology Reviewer Division / MRQA Director Licensing and Brand Support Center of Excellence for Cardiovascular Safety / office of Clinical Pharmacology / /

Person

Tracy Matson / Martin L. Greene / Sheldon Sloan / Jill Sklar / Diane Bild / Gagan Sood / Mat Soukup / Mathematical Statistician / Jonathan Kaltman / Bo Shen / William Hasler / Christopher Granger / John Bloom / V / Sanjay Kaul / Pharmacology Erik Mannaert / Rob Towart / Steven Solga / Brennan Spiegel / Yves Rosenberg / Robert Fiorentino / Aisha Johnson Peterson / DGIEP ODE III / Remarks Joyce Korvick / Jonathan Fox / Nonclinical Ke Zhang / Jean-Pierre Raufman (Chairperson) / Udho Thadani / John R. Teerlink / Sue-Chih Lee / Nonclinical Sushanta Chakder / Henry R. Black / Ronald Fogel / Michael Lauer / Jean-Pierre Raufman / Joyce Korvick / Rachel Rosen / Safety Sheldon Sloan / Aisha Peterson Johnson / David Beattie / Atul Kumar / Minh Doan / Jeffrey Richig / Pharmacology Insook Kim / Garnet Anderson / Eugenio Andraca-Carrera / /

Position

Mathematical Statistician / Senior Director / Pharmacologist / Medicine Portfolio Leader / General / Chair Committee / Officer / Internal Medicine Portfolio Leader / Federal Officer / Acting Designated Federal Officer / Chairperson / Medical Officer / Representative / Director / Clinical Pharmacology Therapeutic Area / Medical Team Leader / Deputy Director for Safety / M.Bioethics Internal Medicine Portfolio Leader / Products / M.P.H. Medical Officer / M.P.H. Medical Team Leader / Ph. Senior Director / /

Product

HT4 / /

ProvinceOrState

Maryland / /

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