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FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER)


Academic year: 2021

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Division of Advisory Committee and Consultant Management Office of Executive Programs




Division of Biostatistics School of Public Health University of Minnesota Minneapolis, Minnesota

Steve N. Georas, MD Professor of Medicine

Division of Pulmonary and Critical Care Medicine University of Rochester Medical Center

Rochester, New York

Mitchell H. Grayson, MD

Associate Professor of Pediatrics, Medicine, Microbiology and Molecular Genetics Division of Allergy and Immunology Medical College of Wisconsin MACC Fund Research Center Milwaukee, Wisconsin

Michelle Harkins, MD

Associate Professor of Medicine University of New Mexico

Division of Pulmonary, Critical Care and Sleep Medicine

Albuquerque, New Mexico

Francis X. McCormack, MD Taylor Professor and Director

Division of Pulmonary, Critical Care, and Sleep Medicine

University of Cincinnati School of Medicine Cincinnati, Ohio

Elaine H. Morrato, DrPH, MPH

Associate Professor Department of Health Systems Management and Policy of Colorado

Anschutz Medical Campus Colorado School of Public Health Aurora, Colorado

Dennis R. Ownby, MD (Chairperson)

Professor of Pediatrics

Division of Allergy, Immunology, and Rheumatology

Georgia Regents University Augusta, Georgia

James M. Tracy, DO

Assistant Clinical Professor of Internal Medicine Creighton University School of Medicine Managing Partner

Allergy Asthma &Immunology Associates, P.C. Omaha, Nebraska


Yanling Yu, MS, PhD (Consumer Representative) President and Co-founder

Washington Advocates for Patient Safety Seattle, Washington


Health-System Medication Safety Coordinator Ohio-Health Pharmacy Services

Dublin, OH

Tobias Gerhard, PhD, RPh Associate Professor

Rutgers University

Department of Pharmacy Practice and Administration Ernest Mario School of Pharmacy

New Brunswick, NJ Jeanmarie Perrone, MD, FACMT

Professor, Emergency Medicine

Director, Division of Medical Toxicology Department of Emergency Medicine

Perelman School of Medicine at the University of Pennsylvania

Philadelphia, Pennsylvania

TEMPORARY MEMBERS (Voting) George Caleb Alexander, MD, MS

Associate Professor of Epidemiology and Medicine Co-Director, Johns Hopkins Center for Drug Safety and Effectiveness

Johns Hopkins Bloomberg School of Public Health Baltimore, Maryland

Raeford E. Brown, Jr. MD, FAAP Professor of Anesthesiology and Pediatrics University of Kentucky Medical Center Kentucky Children’s Hospital


Bruce Carleton, PharmD

Director, Pharmaceutical Outcomes Programme

BC Children's Hospital

Professor of Paediatrics, Population & Public

Health, Pharmaceutical Sciences

Co-Chair, Division of Translational Therapeutics

Department of Pediatrics, Faculty of Medicine

University of British Columbia

Senior Clinician Scientist, Child & Family

Research Institute

Vancouver, British Columbia

Mary Cataletto, MD Attending Physician

Winthrop University Hospital Mineola, New York 11501 Professor of Clinical Pediatrics SUNY Stony Brook

Stony Brook, New York

Robert Dracker, MD Director

Summerwood Pediatrics Infusacare Medical Services Liverpool, New York

Maureen Finnegan, MD Associate Professor

Dept. of Orthopaedic Surgery

University of Texas Southwestern Medical Center Dallas, Texas

Randall P. Flick, MD, MPH Associate Professor of Anesthesiology and Pediatrics Division of Anesthesiology Mayo Clinic

Rochester, Minnesota

Lorraine J. Gudas Professor and Chairman Department of Pharmacology

Weill Cornell Medical College of Cornell University Weill Cornell Medicine

New York, New York Sonia Hernandez-Diaz, MD, DrPH

Professor of Epidemiology

Harvard T.H. Chan School of Public Health Boston, Massachusetts

Mark Hudak, MD

Professor and Chairman of Pediatrics University of Florida College of Medicine - Jacksonville

Jacksonville, Florida J. Steven Leeder, PharmD, PhD

Marion Merrell Dow/Missouri Endowed Chair in Pediatric Clinical Pharmacology

Director, Division of Clinical Pharmacology, Toxicology and Therapeutic Innovation Department of Pediatrics

Children's Mercy Hospital Kansas City, Missouri

Melanie Dawn Nelson, PhD (Patient Representative) Mount Pleasant, Michigan


Ruth M Parker,MD

Prof of Medicine, Pediatrics, and Public Health Emory University School of Medicine

Atlanta, Georgia

Maria Pruchnicki, PharmD, BCPS, BCACP, CLS Associate Professor of Clinical Pharmacy

The Ohio State University College of Pharmacy Specialty Practice Pharmacist, Ambulatory Care The Ohio State University Wexner Medical Center Columbus, Ohio

Christianne L. Roumie, MD MPH Associate Professor Internal Medicine and Pediatrics

Institute for Medicine and Public Health Vanderbilt University

Staff Physician VA Tennessee Valley Healthcare System

Nashville, Tennessee

Maria E. Suarez-Almazor, MD, PhD Barnts Family Distinguished Professor

Section of Rheumatology & Clinical Immunology UT MD Anderson Cancer Center

Houston, Texas

Gary A. Walco, PhD, ABPP

Professor of Anesthesiology & Pain Medicine Adjunct Professor of Pediatrics and Psychiatry University of Washington School of Medicine Director of Pain Medicine

Seattle Children's Hospital Seattle, Washington

Michael Geary White, MD, PhD, FACC, FAAP Staff Pediatric Cardiologist

Ochsner Clinic Foundation New Orleans, Louisiana


Vice President

Respiratory and Immunology Merck Research Laboratories Rahway, New Jersey


DA PARTICIPANTS (Non-Voting) Sally Seymour, MD

Deputy Director for Safety

Division of Pulmonary, Allergy, and Rheumatology Products

Judith A. Racoosin, MD, MPH Deputy Director for Safety

Division of Anesthesia, Analgesia, and Addiction Products


CDR David Moeny, RPh, MPH Deputy Director

Division of Epidemiology II

Office of Pharmacovigilance & Epidemiology Office of Surveillance and Epidemiology CDER, FDA

Steven Adah, PhD

Interdisciplinary Scientist Team Lead Division of Nonprescription Drug Products Office of Drug Evaluation IV (ODE-IV) OND, CDER, FDA


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