Transcript for the July 19, 2016 Meeting of the Dermatologic and Ophthalmic Drugs Advisory ...

349 Pages·2016·0.76 MB·English

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1 FOOD AND DRUG ADMINISTRATION
2 CENTER FOR DRUG EVALUATION AND RESEARCH
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6 DERMATOLOGIC AND OPTHLAMIC DRUGS ADVISORY COMMITTEE
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10 Tuesday, July 19, 2016
11 8:00 a.m. to 4:01 p.m.
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15 FDA White Oak Campus
16 White Oak Conference Center
17 Building 31, The Great Room
18 Silver Spring, Maryland
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A Matter of Record
[phone]
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1 Meeting Roster
2 DESIGNATED FEDERAL OFFICER (Non-Voting)
3 Jennifer Shepherd, RPh
4 Division of Advisory Committee and
5 Consultant Management
6 Office of Executive Programs, CDER, FDA
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8 DERMATOLOGIC AND OPHTHALMIC DRUGS ADVISORY
9 COMMITTEE MEMBERS (Voting)
10 Michael Bigby, MD
11 (Chairperson)
12 Associate Professor of Dermatology
13 Harvard Medical School and
14 Beth Israel Deaconess Medical Center
15 Boston, Massachusetts
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17 Ken Katz, MD, MSc, MCSE
18 Dermatologist
19 Kaiser Permanente
20 San Francisco, California
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A Matter of Record
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1 DERMATOLOGIC AND OPHTHALMIC DRUGS ADVISORY
2 COMMITTEE MEMBER (Non-Voting)
3 Marla B. Sultan, MD, MBA
4 (Industry Representative)
5 Global Clinical Lead, Clinical Development
6 Pfizer, Inc.
7 New York, New York
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9 TEMPORARY MEMBERS (Voting)
10 Bonnie H. Arkus, RN
11 (Acting Consumer Representative)
12 President, Women’s Heart Foundation
13 Hamilton Township, New Jersey
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15 Warren B. Bilker, PhD
16 Professor of Biostatistics
17 Department of Biostatistics and Epidemiology
18 Perelman School of Medicine
19 University of Pennsylvania
20 Philadelphia, Pennsylvania
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A Matter of Record
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1 Michael J. Blaha, MD, MPH
2 Director of Clinical Research and Assistant
3 Professor
4 Johns Hopkins Ciccarone Center for Prevention of
5 Heart Disease
6 Baltimore, Maryland
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8 Erica Brittain, PhD
9 Mathematical Statistician and Deputy Branch Chief
10 Biostatistics Research Branch
11 National Institute of Allergy and Infectious
12 Disease (NIAID)
13 National Institutes of Health (NIH)
14 Bethesda, Maryland
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16 John J. DiGiovanna, MD
17 Senior Research Physician
18 DNA Repair Section
19 Dermatology Branch
20 Center for Cancer Research
21 National Cancer Institute, NIH
22 Bethesda, Maryland
A Matter of Record
[phone]
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1 Lynn A. Drake, MD
2 Lecturer
3 Harvard Medical School
4 Department of Dermatology
5 Massachusetts General Hospital
6 Boston, Massachusetts
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8 Michael R. Irwin, MD
9 Cousins Distinguished Professor of Psychiatry and
10 Biobehavioral Sciences, David Geffen School of
11 Medicine at UCLA
12 Distinguished Professor of Psychology, UCLA
13 College of Letters and Sciences
14 Director, Cousins Center for
15 Psychoneuroimmunology, Semel Institute for
16 Neuroscience
17 Director, Mindful Awareness Research Center
18 Los Angeles, California
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A Matter of Record
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1 Francis E. Lotrich, MD, PhD
2 Associate Professor of Psychiatry
3 University of Pittsburgh Medical Center
4 Pittsburgh, Pennsylvania
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6 Stephen R. Marder, MD
7 Professor and Director, Section on Psychosis
8 Semel Institute for Neuroscience at UCLA
9 Los Angeles, California
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11 Elaine H. Morrato, DrPH, MPH
12 Associate Dean for Public Health Practice
13 Associate Professor Department of Health
14 Systems
15 Management and Policy
16 Colorado School of Public Health
17 University of Colorado Anschutz Medical Campus
18 Aurora, Colorado
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A Matter of Record
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1 Matthew V. Rudorfer, MD
2 Chief, Somatic Treatments and Psychopharmacology
3 Program
4 Division of Services and Intervention Research
5 National Institute of Mental Health (NIMH), NIH
6 Bethesda, Maryland
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8 Elizabeth Smith
9 (Patient Representative)
10 Burke, Virginia
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12 Ming T. Tan, PhD
13 Professor & Chair
14 Department of Biostatistics, Bioinformatics &
15 Biomathematics
16 Georgetown University
17 Washington, District of Columbia
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A Matter of Record
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1 Consuelo Walss-Bass, PhD
2 Associate Professor
3 Department of Psychiatry and Behavioral Sciences
4 McGovern Medical School
5 University of Texas Health Science Center at
6 Houston
7 Houston, Texas
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9 David D. Waters, MD
10 Professor Emeritus,
11 Division of Cardiology,
12 San Francisco General Hospital
13 Department of Medicine
14 University of California, San Francisco
15 San Francisco, California
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17 Julie M. Zito, PhD
18 Professor of Pharmacy and Psychiatry
19 University of Maryland, Baltimore
20 Pharmaceutical Health Services Department
21 Baltimore, Maryland
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A Matter of Record
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1 FDA PARTICIPANTS (Non-Voting)
2 Amy G. Egan, MD, MPH
3 Deputy Director
4 Office of Drug Evaluation III (ODE-III)
5 Office of New Drugs (OND), CDER, FDA
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7 Kendall A. Marcus, MD
8 Director
9 Division of Dermatology and Dental Products
10 (DDDP)
11 ODE-III, OND, CDER, FD
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13 Gary Chiang , MD, MPH
14 Medical Officer
15 DDDP, ODE-III, OND, CDER, FDA
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17 Cynthia L. LaCivita, PharmD
18 Director
19 Division of Risk Management (DRISK), Office of
20 Medication Error Prevention and Risk Management
21 Office of Surveillance and Epidemiology (OSE)
22 CDER, FDA
A Matter of Record
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1 Simone P. Pinheiro, ScD, MSc
2 Deputy Director (Acting)
3 Division of Epidemiology I, Office of
4 Pharmacovigilance and Epidemiology (OPE)
5 OSE, CDER, FDA
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A Matter of Record
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