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Drug Safety and Risk Management Advisory Committee Roster

Drug Safety and Risk Management Advisory Committee Roster

Applying for Membership on FDA Advisory Committees

As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees.

Current Number of Vacancies = 0
Note, one or more vacancies may be in the nomination process or a final appointment may have been made.

Chairperson
Sonia Hernandez-Diaz, MD, MPH, DrPH
Expertise: Pharmacoepidemiology
Term: 6/1/2018 – 5/31/2022
Professor of Epidemiology
Department of Epidemiology
Harvard T.H. Chan School of Public Health
677 Huntington Avenue, Room 816
Boston, Massachusetts 02115

Designated Federal Officer
Philip A. Bautista, PharmD
Division of Advisory Committee and Consultant Management
Office of Executive Programs
Center for Drug and Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
(301) 796-9001 Fax: (301) 847-8533
E-mail: DSaRM@fda.hhs.gov


Denise M. Boudreau, PhD, RPh
Expertise: Pharmacoepidemiology
Term: 6/1/2017 – 5/31/2021
Senior Scientific Investigator
Kaiser Permanente Health Research Institute
Kaiser Permanente Washington
1730 Minor Avenue, Suite 1600
Seattle, Washington 98101
Professor (Affiliate)
Departments of Pharmacy and Epidemiology
University of Washington
Seattle, Washington 98101

Karim Anton Calis, PharmD, MPH, FASHP, FCCP
Expertise: Medication Safety
Term: 6/1/2019 – 5/31/2024
Director of Clinical Research and Compliance
Office of the Scientific Director
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institutes of Health
Hatfield Clinical Research Center, 10-CRC
10 Center Drive (MSC 1109)
Bethesda, Maryland 20892


Marie R. Griffin, MD, MPH
Expertise: Pharmacoepidemiology and Internal Medicine
Term: 6/1/2018 – 5/31/2022
Professor, Health Policy and Medicine
Director, Vanderbilt MPH Program
Department of Health Policy
Vanderbilt University Medical Center
Village at Vanderbilt, Suite 2100
1500 21st Avenue South,
Nashville, Tennessee 37212

Laurel A. Habel, MPH, PhD
Expertise: Epidemiology
Term: 6/1/2017 – 5/31/2021
Associate Director, Cancer Research
Division of Research
Kaiser Permanente Northern California
2000 Broadway
Oakland, California 94612


Martin Kulldorff, PhD
Expertise: Biostatistics
Term: 6/1/2018 – 5/31/2022
Professor of Medicine and Biostatistician
Division of Pharmacoepidemiology and Pharmacoeconomics
Department of Medicine
Harvard Medical School and Brigham & Women's Hospital
1620 Tremont Street, Suite 3030
Boston, Massachusetts 02120

Steven B. Meisel, PharmD, CPPS
Expertise: Medication Safety
Term: 6/1/2017 – 5/31/2021
System Director of Medication Safety
Fairview Health Services
711 Kasota Avenue
Minneapolis, Minnesota 55414


*Suzanne B. Robotti
Expertise: Consumer Representative
Term: 1/19/2017 – 5/31/2020
Executive Director
DES Action USA
Founder and President
MedShadow Foundation
178 Columbus Avenue #237182
New York, New York 10023

Anne-Michelle Ruha, MD, FACMT
Expertise: Medical Toxicology
Term: 9/19/2016 – 5/31/2020
Vice Chief
Department of Medical Toxicology
Banner University Medical Center
Professor of Internal Medicine and Emergency Medicine
University of Arizona College of Medicine
1012 East Willetta Street
Phoenix, Arizona 85006


**Linda Scarazzini, MD, RPh
Expertise: Industry Representative
Term: 3/31/2016-10/31/2019
Vice President
Pharmacovigilance and Patient Safety
Abbvie
1 North Waukegan Road
North Chicago, Illinois 60064-6116

Soko Setoguchi, MD, DrPH
Expertise: Pharmacoepidemiology, Internal Medicine, and Cardiology
Term: 6/1/2017 – 5/31/2021
Associate Professor of Medicine and Epidemiology
Rutgers Robert Wood Johnson Medical School
Rutgers University
112 Paterson Street
New Brunswick, New Jersey 08901


Terri L. Warholak, PhD, RPh, CPHQ, FAPhA
Expertise: Drug Safety
Term: 9/19/2016 – 5/31/2020
Professor and Assistant Dean
Academic Affairs and Assessment
College of Pharmacy
University of Arizona
1295 North Martin Avenue
Tucson, Arizona 85721


* Consumer Representative
** Industry Representative, (non voting)

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