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Summary Minutes of the Cardiovascular and Renal Drugs Advisory Committee September 8, 2011 Location: UMUC Inn and Conference Center by Marriott, 3501 University Boulevard East, Adelphi, Maryland, 20783 All external reque
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City

Adelphi / /

Company

Johnson & Johnson Pharmaceutical Research and Development L.L.C. / ITT / M.D. / /

Country

United States / /

Event

Person Communication and Meetings / Product Issues / Product Recall / /

Facility

Robert Temple / University Boulevard East / UMUC Inn / /

IndustryTerm

stroke prevention / inferior product / prevention of stroke / healthcare providers / /

MedicalCondition

Study Stroke / strokes / systemic embolus / systemic embolism / blood clots / non-CNS systemic embolism / Isch stroke / nervous system systemic embolus / end stage liver disease / end stage renal disease / VKA naïve Prior stroke / Hem stroke / nonvalvular atrial fibrillation / stroke / paroxysmal atrial fibrillation / skin necrosis / non-valvular atrial fibrillation / atrial fibrillation / /

MedicalTreatment

cardioversion / drug therapy / /

Organization

office of Drug Evaluation / Food and Drug Administration / Risk Management Advisory Committee / Clinical Reviewer Division of Cardiovascular and Renal Products Clarifying Questions / Drug Safety and Risk Management Advisory Committee / Center for Drug Evaluation and Research / Clinical Reviewer Division of Cardiovascular and Renal Products Issues Affecting Interpretation / Advisory Committee / Cardiovascular and Renal Drugs Advisory Committee / Duke University Medical Center / /

Person

Gary R. Peters / Christopher C. Nessel / A. Michael Lincoff / Allan Coukell / Debra McCall / Kristina Toliver / Scott Emerson / Duke Translational / Remarks Norman Stockbridge / Sanjay Kaul / Preston Dunnmon / Thomas Fleming / Martin Rose / Andrei Kindzelski / Jonathan Fox / Steven Nissen / Norman Stockbridge / Robert M. Califf / Philip Sager / Darren McGuire / Mori Krantz / Kristina A. Toliver / Judith Hochman / Vasilios Papademetriou / /

Position

Director / Division of Cardiovascular and Renal Products / Senior Director / Clinical Research / Chair Acting Committee / Vice President / Cardiovascular Development / Federal Officer / Director / Duke / Director / Vice Chancellor / Major / Chair / Designated Federal Officer / Representative / Director / Clinical Research Johnson & Johnson Pharmaceutical Research / /

Product

consent / /

ProvinceOrState

Maryland / /

PublishedMedium

The FDA review / /

Technology

pharmacokinetics / standardized algorithm / /

SocialTag