FDA Sponsor Presentations Introduction Otsuka Pharmaceutical Company Ltd / Commercialization Inc. / Ostuka Pharmaceutical Company Ltd. / PhD / Risk Management/ Office / Risk Management / Otsuka Pharmaceutical Company Ltd / /
Facility
Robert Temple / FDA White Oak Campus / White Oak Conference Center / /
MedicalCondition
advanced disease / severe kidney disease / ADPKD / liver failure / slowly progressive diseases / albuminuria / chronic kidney disease / severe liver injury / slow kidney disease / MS / both less severe kidney disease / hypertension / genetic disease / disease / kidney disease / less severe kidney disease / Dominant Polycystic Kidney Disease / autosomal dominant polycystic kidney disease / pain / kidney failure / drug-induced liver injury / liver injury / /
OperatingSystem
OSE / /
Organization
National Kidney Foundation / PKD Foundation / office of New Drugs / Food and Drug Administration / office of Surveillance and Epidemiology / Risk Management/ office of Medication Error Prevention / Drug Safety and Risk Management Advisory Committee / Emory University / Renal Drugs Advisory Committee / National Organization for Rare Disorders / FDA / Center for Drug Evaluation and Research / Advisory Committee / Cardiovascular and Renal Drugs Advisory Committee / /
Person
A. Michael Lincoff / Cheryl Bost / A. Toliver / Robert McQuade / Silver Spring / Sidney Wolfe / Julia Lewis / Ellis Unger / Scott Emerson / Remarks Norman Stockbridge / Ashley Phelps / Katherine Michiels / Alan S. Kliger / Naga P. Chalasani / Cathy Perkins / Pathophysiology Vicente Torres / Sarah Franklin / Kimberly Lehrfeld / Michelle Davis / Findings John Lawrence / Michael Proschan / Jennifer Li / Jay Hoofnagle / Cardiovascular / Elaine Morrato / Harold A. Saul / Rob Scott / Stuart Rich / A. Michael Lincoff (Chairperson) / Aliza Thompson / Lorrie Rome / Norman Stockbridge / Bill Brazell / Philip Sager / Susan Broyles / Michele Orza / Kristina A. Toliver / Michael Flessner / Diane E. Dorman / James deLemos / William Cooper / Vasilios Papademetriou / /
Position
VP & Chief Strategic Officer / Director / Division of Cardiovascular and Renal Products / PharmD Drug Risk Management Analyst Division / Director / Global Clinical Development / Federal Officer / CEO / Clinical Team Leader / Chairperson / Representative / Designated Federal Officer / PharmD Designated Federal Officer / Professor of Medicine / Director / /
August 5, 2013 Meeting of the Cardiovascular and Renal Drugs Advisory Committee Summary Minutes of the Drug Safety and Risk Management Advisory Committee Meeting August 5, 2013