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Health / Osteoporosis / Menopause / Anatomy / Amgen / Denosumab / Medicine


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 It was current when produced, but is no longer maintained and may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

Safety Amgen Inc / Ligand / Amgen / /

Facility

MD Columbia University Medical Center / /

IndustryTerm

prevention of osteoporosis / treatment of osteoporosis / biologic license applications / /

MedicalCondition

osteoporosis / prostate cancer / MS / breast cancer / Postmenopausal Osteoporosis / /

Organization

Division of Reproductive and Urologic Drugs / Urologic Drugs / Advisory Committee for Reproductive Health Drugs / Columbia University / FOOD AND DRUG ADMINISTRATION Center for Drug Evaluation / U.S. Food and Drug Administration / Division of Reproductive / Research Advisory Committee / /

Person

Kalyani Bhatt Designated / Theresa Kehoe / Catherine Stehman-Breen / Adrienne Rothstein / David Lacey / Paul Eisenberg / Vaishali Popat / Sandra Carson / George Benson / /

Position

Senior Vice President Global Regulatory Affairs / Medical Officer / DRUP Denosumab Safety Analysis / Chair / President / National Osteoporosis Foundation Discovery / Analyst / Clinical Team Leader / Vice President Global Development Amgen Inc Denosumab Pharmacovigilance Plan / Deputy Director / Federal Official / Senior Vice President Research Amgen Inc Denosumab Clinical Efficacy and Safety Assessments / /

ProvinceOrState

New York / /

SocialTag