Transcript for the December 6, 2016 Meeting of the Bone, Reproductive and Urologic Drugs ...

352 Pages·2017·0.48 MB·English

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1 FOOD AND DRUG ADMINISTRATION

2 CENTER FOR DRUG EVALUATION AND RESEARCH

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7 BONE, REPRODUCTIVE, AND UROLOGIC

8 DRUGS ADVISORY COMMITTEE (BRUDAC)

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12 Tuesday, December 6, 2016

13 8:00 a.m. to 4:10 p.m.

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17 Thomas Douglas Conference Center

18 10000 New Hampshire Avenue

19 Silver Spring, Maryland

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A Matter of Record
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1 Meeting Roster

2 ACTING-DESIGNATED FEDERAL OFFICER (Non-Voting)

3 LaToya Bonner, PharmD

4 Division of Advisory Committee and Consultant

5 Management

6 Office of Executive Programs, CDER, FDA

7 BONE, REPRODUCTIVE, AND UROLOGIC DRUGS ADVISORY

8 COMMITTEE MEMBERS

9 (Voting)

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11 Douglas C. Bauer, MD

12 Professor of Medicine and Epidemiology &

13 Biostatistics

14 University of California, San Francisco

15 San Francisco, California

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3

1 Toby Chai, MD

2 Vice Chair of Research

3 Co-Director of Female Pelvic Medicine and

4 Reconstructive Surgery Program

5 Department of Urology

6 Yale School of Medicine

7 New Haven, Connecticut

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9 Kathryn M. Curtis, PhD

10 Epidemiologist

11 Women’s Health and Fertility Branch

12 Division of Reproductive Health

13 Centers for Disease Control and Prevention

14 Atlanta, Georgia

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16 Roger T. Dmochowski, MD

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
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4

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

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8 Vivian Lewis, MD

9 (Chairperson)

10 Vice Provost for Faculty Development & Diversity

11 Professor, Obstetrics and Gynecology

12 University of Rochester

13 Rochester, New York

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15 Stuart S. Howards, MD

16 Professor of Urology

17 Department of Urology

18 University of Virginia

19 Charlottesville, Virginia

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A Matter of Record
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1 Sarah E. Sorscher, JD, MPH

2 (Consumer Representative)

3 Researcher

4 Public Citizen’s Health Research Group

5 Washington, District of Columbia

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7 Gerard G. Nahum, MD, FACOG

8 (Industry Representative)

9 Vice President of Global Development, General

10 Medicine

11 Women’s Healthcare, Long-Acting Contraception,

12 Medical Devices, and Special Projects

13 Bayer HealthCare Pharmaceuticals, Inc.

14 Parsippany, New Jersey

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1 TEMPORARY MEMBERS (Voting)

2 Robert A. Adler, MD

3 Chief, Endocrinology and Metabolism

4 Hunter Holmes McGuire Veterans Affairs

5 Medical Center

6 Professor of Epidemiology and Community Health

7 Professor of Internal Medicine

8 Medical College of Virginia

9 Virginia Commonwealth University

10 Richmond, Virginia

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12 George A. Bishopric

13 (Patient Representative)

14 Fort Lauderdale, Florida

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16 Diane M. Biskobing, MD

17 Professor of Medicine

18 Assistant Dean for Advancement of the

19 Curriculum

20 Medical College of Virginia

21 Virginia Commonwealth University

22 Richmond, Virginia
A Matter of Record
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1 Robert E. Brannigan, MD

2 Professor of Urology

3 Department of Urology

4 Feinburg School of Medicine

5 Northwestern University

6 Chicago, Illinois

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8 Glenn D. Braunstein, MD

9 Professor of Medicine, Emeritus

10 David Geffen School of Medicine

11 University of California, Los Angeles

12 Chief Medical Officer

13 Pathways Genomics

14 San Diego, California

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16 Kenneth Burman, MD

17 Chief, Endocrine Section

18 Medstar Washington Hospital Center

19 Professor, Department of Medicine

20 Georgetown University

21 Washington, District of Columbia

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A Matter of Record
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1 Daniel Gillen, PhD

2 Chair and Professor

3 Department of Statistics

4 University of California, Irvine

5 Irvine, California

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7 Philip Hanno, MD, MPH

8 Professor of Urology in Surgery

9 Director of Urinary Infection, Inflammation, and

10 Interstitial Cystitis

11 University of Pennsylvania School of Medicine

12 Philadelphia, Pennsylvania

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14 Kurt McCammon, MD

15 Professor, Chairman, and Program Director

16 Department of Urology

17 Devine Chairman in Genitourinary Reconstructive

18 Surgery

19 Eastern Virginia Medical School

20 Norfolk, Virginia

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A Matter of Record
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1 Jay Sandlow, MD

2 Professor of Urology and Obstetrics/Gynecology

3 Vice-Chairman of Urology

4 Department of Urology

5 Medical College of Wisconsin

6 Milwaukee, Wisconsin

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8 Peter Schlegel, MD

9 James J. Colt Professor of Urology

10 Professor of Reproductive Medicine

11 Weill Cornell Medical College

12 Chairman and Urologist-in Chief

13 Department of Urology

14 New York Presbyterian Hospital

15 New York, New York

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17 Abraham Thomas, MD, MPH

18 Senior Vice President and Chair

19 Department of Medicine

20 New York University Lutheran

21 Brooklyn, New York

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A Matter of Record
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1 Kevin Weinfurt, PhD

2 Professor

3 Department of Psychiatry and Behavioral Sciences

4 Department of Psychology and Neuroscience

5 Deputy Director

6 Center for Clinical and Genetic Economics

7 Duke Clinical Research Institute

8 Duke University

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10 FDA PARTICIPANTS (Non-Voting)

11 Hylton V. Joffe, MD, MMSc

12 Director

13 Division of Bone, Reproductive and Urologic

14 Products (DBRUP)

15 Office of Drug Evaluation III (ODE III)

16 Office of New Drugs (OND)

17 CDER, FDA

18 Durham, North Carolina

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