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Pharmaceutical sciences / Monoclonal antibodies / Pharmacology / Belimumab / Center for Drug Evaluation and Research / Systemic lupus erythematosus / Human Genome Sciences / B-cell activating factor / Food and Drug Administration / Health / Anatomy


U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may
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Company

The Hopkins Lupus Cohort / M.D. / D. / /

Facility

Marriott Inn / Conference Center University of Maryland University College / Medicine University of Toronto Mechanism / /

MedicalCondition

disease / active / autoantibody-positive systemic lupus erythematosus / Allergy / Pulmonary / Regulatory Affairs Human Genome Sciences Systemic Lupus Erythematosus / /

Organization

office of Drug Evaluation / office of New Drugs / Arthritis Advisory Committee / U.S. Food and Drug Administration / Biostatistics Office / University of Maryland University College / Johns Hopkins University / Center for Drug Evaluation and Research / Statistical Reviewer Division / Medicine University of Toronto Mechanism of Action / OND CDER / /

Person

Arthritis Advisory / Genome Sciences Safety Simon Cooper / Neil / Opening Remarks Badrul Chowdhury / Statistical Reviewer / Badrul Chowdhury / Yvette Waples / Genome Sciences Efficacy William Freimuth / Diana Daly / Need Murray Urowitz / Ruthanna Davi / Belimumab Thi Migone / Rosemarie Neuner / /

Position

Director / Clinical Immunology Human / Director / Clinical Research Human / Executive Director / Professor / Director / Division of Pulmonary / Director / Co-Director / Director / Regulatory Affairs Human Genome Sciences Systemic Lupus Erythematosus / Acting Designated Federal Official / Professor / Division of Rheumatology / Vice President / Clinical Research Human / BSN Executive Director / Regulatory Affairs / Director / DPARP / Chair / /

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