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Clinical research / Center for Drug Evaluation and Research / Merck & Co. / Dermatologic and Ophthalmic Drugs Advisory Committee / Oncology Drug Advisory Committee / Food and Drug Administration / Health / Pharmaceutical sciences


The committee will discuss saxagliptin tablets, by Bristol-Myers Squibb, for the treatment of hyperglycemia in adults with type 2 diabetes mellitus
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City

Victoria / /

Company

Sponsor Presentation Merck & Co. Inc. / MERCK & Co. Inc / M.D. / Clinical Research Hepatology Merck & Co. Inc. / Cargill / Global Regulatory Affairs Merck & Co. Inc. / Regulatory Affairs Merck & Co. Inc. / Clinical Research Merck & Co. Inc. / /

Facility

Food and Drug Administration Campus / White Oak Conference Center / /

MedicalCondition

compensated liver disease / hepatitis C / infection / chronic hepatitis C / /

Organization

Center for Drug Evaluation & Research / office of New Drugs / FOOD AND DRUG ADMINISTRATION / M.S.C.E. Committee Acting Chair Antiviral Drugs Advisory Committee / office of Antimicrobial Products / office of Translational Sciences / Pharmacometrics office of Clinical Pharmacology / Pharmacometrics Reviewer Division / /

Person

Jeffrey Murray / Poonam Mishra / Pharmacometrics Reviewer / Debra Birnkrant / Jeffrey Florian / Safety Clifford Brass / Keith Gottesdiener / Victoria A. Cargill / Efficacy Jan Albrecht / Laurie MacDonald / Paul Tran / /

Position

Federal Officer / Vice President Global Clinical Development / Vice-President / Medical Officer Division of Antiviral Products / Executive Director / Director / Director / Division of Antiviral Products / Deputy Director Division of Antiviral Products / /

Product

ribavirin / peginterferon / /

Technology

genotype / /

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