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U.S. Department of Health and Human Services

Advisory Committees

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Slides from the January 13, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee

 

Persons with disabilities having problems accessing the PDF file(s) below may call (301) 796-3634 for assistance
 
 
FDA
 
FDA Core Presentations, (NDA) 22-562, CARBAGLU (carglumic acid) Tablets, Orphan Europe, S.A.R.L, for the January 13, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee:
 
Lynne Yao, M.D., Acting Medical Officer Team Leader Division of Gastroenterology Products ODE III, OND,CDER, FDA (PDF – 102KB)
 
Helen Sile, M.D. Medical Officer Division of Gastroenterology Products ODE III, OND, CDER, FDA and LCDR Kristina Estes, Pharm.D. Clinical Pharmacology Reviewer Division of Gastroenterology Products ODE III, OND, CDER, FDA (PDF – 695KB) 
 
 
Sponsor
 
Orphan Europe, S.A.R.L, Core Presentation (NDA) 22-562, CARBAGLU (carglumic acid) Tablets, for the January 12, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF -1.08MB)
 
 
Mendel Tuchman, M.D. Chief Research Officer Scientific Director, Children's Research Institute Professor of Pediatrics, Biochemistry & Molecular Biology Children's National Medical Center (PDF – 488KB)