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U.S. Department of Health and Human Services

Advisory Committees

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Roster of the Clinical Chemistry and Clinical Toxicology Devices 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 toxicology, clinical chemistry, endocrinology and oncology 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: 2

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

Henry C. Nipper, Ph.D., DABCC
Expertise:  Clinical Chemistry; Toxicology
Term:  05/12/2011 - 02/28/2015
Asst. Dean for Admissions
School of Medicine
Creighton University
2500 California Plaza
Omaha, NE  68178-0078
Designated Federal Official
Patricio G. Garcia, M.P.H.
LCDR, US Public Health Service
Center for Devices and Radiological Health
Office of Device Evaluation
10903 New Hampshire Avenue
WO Bldg. 66 Room 3628
Silver Spring, Maryland 20903
Office: (301) 796-6875
Fax:  (301) 847-8120

**David A. Armbruster, Ph.D.
Expertise: Toxicology
Term: 02/27/2013-02/28/2017
Executive Vice Chairman, Dept. of Medicine
University of Texas Health Science Center
7303 Floyd Curl Dr. MC 7870
San Antonio, TX 78229

Barbara M. Goldsmith, Ph.D., FACB
Expertise:  Clinical Chemistry, Pediatrics
Term:  09/25/2012 - 02/28/2016
VP, Marketing, Membership & Education
Clinical & Laboratory Standards Institute
950 West Valley Road
Suite 2500
Wayne, PA 19087

*Monica J. Harmon, R.N., M.P.H., M.S.N.
Expertise: Nursing, Public Health
Term: 03/01/2013 - 02/28/2017
Yeadon, PA 19050

Karol E. Watson, M.D., Ph.D., FACC
Expertise:  Cardiology, Internal Medicine
Term:  09/25/2012 - 02/28/2016
Assoc. Prof. of Medicine/Div. of Cardiology
Geffen School of Medicine at UCLA
650 Charles E. Young Dr. South
A2-237 CHS MC: 167917
Los Angeles, CA  90095

William E. Winter, M.D.
Expertise:  Clinical Chemistry; Diabetes
Term:  05/12/2011 - 02/28/2015
Medical Director & Section Chief
Clinical Chemistry Department
Shands Hospital
1600 Southwest Archer Road
Gainesville, FL  32610

Kathleen L. Wyne, M.D., Ph.D.
Expertise: Diabetes; Endocrinology
Term:  09/29/2011 to 02/28/2015
Director of Clinical Research
Diabetes Research Center
Methodist Hospital Research Institute
6550 Fannin St., Room SM1001
Houston, TX  77030


* Consumer Representative
** Industry Representative