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  1. Molecular and Clinical Genetics Panel

Roster of the Molecular and Clinical Genetics Panel

Purpose: The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including clinical and molecular genetics and makes appropriate recommendations to the Commissioner of Food and Drugs.

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: 1

Note, one or more vacancies may be in the nomination process or a final appointment may have been made.

Chairperson
Andrea Ferreira-Gonzalez, Ph.D. 
Expertise: Genetics; Molecular Biology
Term: 08/18/2023 – 05/31/2027
Professor of Pathology and 
Chair, Division of Molecular Diagnostics
Virginia Commonwealth University
403 North 13th St., Rm. 247
Richmond, VA 23298

Designated Federal Officer
Serina A. Hunter-Thomas, M.S.A, B.S.N., R.N.
Center for Devices and Radiological Health
Office of Management
10903 New Hampshire Avenue
WO Bldg. 66 Rm 5211
Silver Spring, Maryland 20993
Office: (240) 402-5771

Nathan W. Winslow **
Expertise: Regulatory Affairs
Term: 02/09/2023 – 05/31/2027
Global Head, Regulatory Affairs
Roche Diagnostics Solution
4300 Hacienda Drive
Pleasanton, CA 94960

Steven M. Lipkin, M.D., Ph.D.
Expertise: Medical Genetics
Term: 06/13/2023 – 05/31/2026
Gladys and Roland Harriman Professor of Medicine
and Vice Chair for Research,
Department of Medicine
Weill-Cornell Medical College
1315 York Avenue
New York, NY 10021

Steven J. Skates, Ph.D.
Expertise: Biostatistics; Early Detection
Term: 09/20/2023 – 05/31/2025
Associate Professor of Medicine (Biostatistics)
Massachusetts General Hospital 
50 Staniford Street, Suite 560
Boston, MA 02114

Deb Schrag, M.D., M.P.H.
Expertise: Gastrointestinal Oncology, Population Science
Term: 01/19/2024 – 05/31/2027
Chair, Department of Medicine
Memorial Sloan Kettering Cancer Center
1275 York Avenue
New York, NY 10065

Alexander D. Borowsky, MD, HCLD
Expertise: Molecular Diagnostics
Term: 01/19/2024 – 05/31/2026
Professor of Pathology and Laboratory Medicine
UC Davis School of Medicine
3005 Research I
Sacramento, CA 95817

Renata C. Gallagher, M.D., Ph.D.
Expertise: Medical and Biochemical Genetics
Term: 05/09/2024 – 05/31/2028
Professor Emeritus
University of California, San Francisco
School of Medicine, Department of Pediatrics
550 16th Street
San Francisco, CA 94143

Nina Gold, M.D.
Expertise: Clinical Genetics
Term: 05/09/2024 – 05/31/2028
Medical Genetics Residency Director
Div. of Medical Genetics and Metabolism
Massachusetts General Hospital
175 Cambridge Street
Boston, MA 02114

* Consumer Representative
** Industry Representative

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