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Polycystic kidney disease / Autosomal dominant polycystic kidney / Cystic kidney disease / Tolvaptan / Center for Drug Evaluation and Research / Food and Drug Administration / Renal failure / Autosomal recessive polycystic kidney / Kidney diseases / Medicine / Health


FOOD AND DRUG ADMINISTRATION (FDA)
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Company

Commercialization Inc. / Sponsor Presentations Otsuka Pharmaceutical Company Ltd / PhD / Otsuka Pharmaceutical Company Ltd / /

Facility

FDA White Oak Campus / White Oak Conference Center / /

MedicalCondition

Dominant Polycystic Kidney Disease / autosomal dominant polycystic kidney disease / kidney failure / genetic disease / ADPKD / kidney disease / /

OperatingSystem

OSE / /

Organization

Emory University / Center for Drug Evaluation and Research / office of New Drugs / FOOD AND DRUG ADMINISTRATION / office of Surveillance and Epidemiology / Renal Products / Cardiovascular and Renal Drugs Advisory Committee / Risk Management/ office of Medication Error Prevention / Renal Drugs Advisory Committee / /

Person

Aliza Thompson / A. Michael Lincoff / Cardiovascular / Robert McQuade / Opening Remarks Norman Stockbridge / Silver Spring / Kristina A. Toliver / Pathophysiology Vicente Torres / Statistical Findings John Lawrence / Kimberly Lehrfeld / /

Position

Chairperson / Executive VP & Chief Strategic Officer / Director / Division of Cardiovascular / PharmD Designated Federal Officer / Director / Global Clinical Development / Clinical Team Leader / PharmD Drug Risk Management Analyst / Professor of Medicine / Director / /

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