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Transcript for the January 9, 2018 Meeting of the Bone, Reproductive and Urologic Drugs Advisory ... PDF

363 Pages·2017·1.05 MB·English
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Preview Transcript for the January 9, 2018 Meeting of the Bone, Reproductive and Urologic Drugs Advisory ...

1 1 FOOD AND DRUG ADMINISTRATION 2 CENTER FOR DRUG EVALUATION AND RESEARCH 3 4 5 6 BONE, REPRODUCTIVE, AND UROLOGIC DRUGS 7 ADVISORY COMMITTEE (BRUDAC) MEETING 8 9 10 Tuesday, January 9, 2018 11 7:59 a.m. to 4:24 p.m. 12 13 14 15 College Park Marriott Hotel and Conference Center 16 General Vessey Ballroom 17 3501 University Boulevard East 18 Hyattsville, Maryland 19 20 21 22 A Matter of Record (301) 890-4188 2 1 Meeting Roster 2 DESIGNATED FEDERAL OFFICER (Non-Voting) 3 Kalyani Bhatt, BS, MS 4 Division of Advisory Committee and Consultant 5 Management 6 Office of Executive Programs, CDER, FDA 7 8 BONE, REPRODUCTIVE, AND UROLOGIC DRUGS ADVISORY 9 COMMITTEE MEMBERS (Voting) 10 Douglas C. Bauer, MD 11 Professor of Medicine and Epidemiology & 12 Biostatistics 13 University of California, San Francisco 14 San Francisco, California 15 16 Roger T. Dmochowski, MD (via phone) 17 Professor of Urology 18 Director, Pelvic Medicine and Reconstruction 19 Fellowship 20 Department of Urology 21 Vanderbilt University Hospital 22 Nashville, Tennessee A Matter of Record (301) 890-4188 3 1 Matthew T. Drake, MD, PhD 2 Associate Professor of Medicine 3 Chair, Metabolic Bone Disease Core Group 4 Division of Endocrinology 5 Mayo Clinic College of Medicine 6 Rochester, Minnesota 7 8 Beatrice J. Edwards, MD, MPH, FACP 9 Associate Professor 10 Department of General Internal Medicine 11 Division of Internal Medicine 12 University of Texas MD Anderson Cancer Center 13 Houston, Texas 14 15 Margery Gass, MD 16 Executive Director Emerita 17 North American Menopause Society 18 Fred Hutchinson Cancer Research Center 19 Seattle, Washington 20 21 22 A Matter of Record (301) 890-4188 4 1 Vivian Lewis, MD 2 (Chairperson) 3 Vice Provost for Faculty Development & Diversity 4 Professor, Obstetrics and Gynecology 5 University of Rochester 6 Rochester, New York 7 8 Pamela A. Shaw, PhD 9 Associate Professor 10 Department of Biostatistics and Epidemiology 11 University of Pennsylvania School of Medicine 12 Philadelphia, Pennsylvania 13 14 Sarah Sorscher, JD, MPH 15 (Consumer Representative) 16 Deputy Director of Regulatory Affairs 17 Center for Science in the Public Interest 18 Washington, District of Columbia 19 20 21 22 A Matter of Record (301) 890-4188 5 1 BONE, REPRODUCTIVE, AND UROLOGIC DRUGS ADVISORY 2 COMMITTEE MEMBERS (Non-Voting) 3 Gerard G. Nahum, MD, FACOG 4 (Industry Representative) 5 Vice President of Global Development, General 6 Medicine 7 Women’s Healthcare, Long-Acting Contraception, 8 Medical Devices, and Special Projects 9 Bayer HealthCare Pharmaceuticals, Inc. 10 Parsippany, New Jersey 11 12 TEMPORARY MEMBERS (Voting) 13 Robert A. Adler, MD 14 Chief, Endocrinology and Metabolism 15 McGuire Veterans Affairs Medical Center 16 Professor of Internal Medicine and of Epidemiology 17 Virginia Commonwealth University School of Medicine 18 Richmond, Virginia 19 20 21 22 A Matter of Record (301) 890-4188 6 1 George Bishopric 2 (Patient Representative) 3 Fort Lauderdale, Florida 4 5 Robert Brannigan, MD 6 Chief of Male Reproductive Medicine and Men's 7 Health in the Department of Urology 8 Professor of Urology 9 Northwestern University School of Medicine 10 Chicago, Illinois 11 12 Glenn D. Braunstein, MD 13 Professor of Medicine 14 Cedars-Sinai Medical Center 15 Los Angeles, California 16 17 18 19 20 21 22 A Matter of Record (301) 890-4188 7 1 Tobias Gerhard, PhD, RPh 2 Associate Professor of Pharmacoepidemiology 3 Ernest Mario School of Pharmacy, and 4 Institute for Health, Health Care Policy and Aging 5 Research 6 Rutgers University 7 New Brunswick, New Jersey 8 9 Stuart S. Howards, MD 10 Professor of Urology 11 Department of Urology 12 University of Virginia 13 Charlottesville, Virginia 14 15 Ziya Kirkali, MD 16 Senior Scientific Advisor 17 National Institute of Kidney 18 National Institute of Health 19 Bethesda, Maryland 20 21 22 A Matter of Record (301) 890-4188 8 1 A. Michael Lincoff, MD 2 Director, Cleveland Clinic Coordinating Center for 3 Clinical Research (C5Research) 4 Vice Chairman, Department of Cardiovascular 5 Medicine and Lerner Research Institute 6 Professor of Medicine 7 Cleveland, Ohio 8 9 Donald E. Mager, PharmD, PhD 10 Associate Professor of Pharmaceutical Sciences 11 University of Buffalo, SUNY 12 Department of Pharmaceutical Sciences 13 School of Pharmacy and Pharmaceutical Sciences 14 Buffalo, New York 15 16 Robert Rej, PhD 17 Associate Professor, School of Public Health, 18 Biomedical Sciences 19 Wadsworth School of Laboratory Sciences 20 Albany Medical College 21 Albany, New York 22 A Matter of Record (301) 890-4188 9 1 Peter W. F. Wilson, MD 2 Professor of Medicine, Division of Cardiology 3 Emory University School of Medicine 4 Atlanta, Georgia 5 6 FDA PARTICIPANTS (Non-Voting) 7 Hylton V. Joffe, MD, MMSc 8 Director 9 Division of Bone, Reproductive and Urologic 10 Products (DBRUP) 11 Office of Drug Evaluation III (ODE III) 12 Office of New Drugs (OND), CDER, FDA 13 14 A. Roger Wiederhorn, MD, DMSci 15 Medical Officer 16 DBRUP, ODE III, OND, CDER, FDA 17 18 Dhananjay D. Marathe, PhD 19 Pharmacometrics Reviewer 20 Division of Pharmacometrics (DPM) 21 Office of Clinical Pharmacology (OCP) 22 Office of Translational Sciences (OTS), CDER, FDA A Matter of Record (301) 890-4188 10 1 Preston Dunnmon, MD 2 Medical Officer 3 Division of Cardiovascular and Renal 4 Products (DCRP) 5 ODE I, OND, CDER, FDA 6 7 Chongwoo Yu, PhD 8 Clinical Pharmacology Reviewer 9 Division of Clinical Pharmacology-III (DCP-III) 10 OCP, OTS, CDER, FDA 11 12 13 14 15 16 17 18 19 20 21 22 A Matter of Record (301) 890-4188

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