Amgen Inc. / Sponsor Presentation Amgen Inc. / Ligand / Affairs & Safety Amgen Inc / President Research Amgen Inc / President Global Development Amgen Inc / M.D. / M.D. Industry / /
Facility
Denosumab Columbia University Medical Center / /
IndustryTerm
other osteoporosis therapies / biologics license applications / treatment of osteoporosis / therapies for hormone sensitive breast or prostate cancer / cancer treatment / supportive care products / prevention of osteoporosis / prevention of bone loss in patients with cancer / healthcare providers / /
MedicalCondition
routine neoplastic disease / metastatic disease / treatment osteoporosis / postmenopausal osteoporosis Question 1a / prostate cancer / MS / breast cancer / prostate cancer Question 4a / Cancer / advanced cancers / disease / Postmenopausal Osteoporosis / bone metastases / postmenopausal osteoporosis Question 2a / osteoporosis / cancer receiving hormone ablation / /
Organization
Advisory Committee for Reproductive Health Drugs / National Osteoporosis Foundation / office of Oncology Drug Products / Columbia University Medical Center / U.S. Food and Drug Administration / Executive Director Foundation for Osteoporosis Research and Education / Center for Drug Evaluation and Research / /
Person
Clifford J. Rosen / Aman U. Buzdar / Kathleen Cody / Lawrence M. Nelson / Scott Emerson / Ethel Siris / Kalyani Bhatt Designated / Martha Solonche / John Bennett / Michael T. Collins / Adrienne Rothstein / Roberta Biegal / David Lacey / Joanne E. Mortimer / Gulbu Uzel / Julia V. Johnson / Sandra Carson / Robert Gut / Ronald Richardson / James L Gulley / Theresa Kehoe / Cindy Pearson / Paul Eisenberg / Julie Beitz / Richard Pazdur / Kalyani Bhatt / Suzanne Demko / Catherine Stehman-Breen / Marilyn Brown Gladys Quinterro Laurel / Merrill Goozner / Vaishali Popat / David J. Margolis / George Benson / /
Position
Attorney / Director / Division / Federal Official / Clinical Team Leader / Chair / Medical Officer / Representative / Analyst / /
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 It was current when produced, but is no longer maintained and may