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Opening Remarks |
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Edward R.B. McCabe, M.D., Ph.D.
SACGHS Chair |
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Oversight of Genetic Technologies, Marketing, and Laboratories and the Role of Pharmacogenetic Tests in Therapeutics |
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Oversight of Genetic Testing Laboratories Through the Clinical Laboratory Improvement Amendments (CLIA) |
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Judith A. Yost, M.A., M.T.
Director, Division of Laboratories and Acute Care
Centers for Medicare & Medicaid Services |
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Plans for Augmenting CLIA to Specifically Address Genetic Testing Laboratory Issues and Concerns |
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D. Joe Boone, Ph.D.
Associate Director for Science, Division of Laboratory Systems
Public Health Practice Program Office
Centers for Disease Control and Prevention |
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Roundtable Discussion |
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Facilitator: Dr. Winn-Deen |
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Impact of Pharmacogenomics on Prescription Drug Labeling |
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Lawrence J. Lesko, Ph.D.
Director, Office of Clinical Pharmacology and Biopharmaceutics
Center for Drug Evaluation and Research
Food and Drug Administration |
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FDA's Current Approach to the Review, Labeling and Marketing of Genetic Tests |
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Steven I. Gutman, M.D.
Director, Office of In Vitro Diagnostics
Center for Devices and Radiological Health |
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FDA's Future Plans to Enhance Oversight of High Risk Genetic Tests |
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David W. Feigal, Jr., M.D., M.P.H.
Director, Center for Devices and Radiological Health
Food and Drug Administration |
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Roundtable Discussion |
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Facilitator: Dr. Leonard |
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FTC's Regulation of the Advertising and Promotion of Consumer Products and Its Application to Genetic Technologies |
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Matthew Daynard, J.D.
Senior Attorney, Advertising Practices Division
Bureau of Consumer Protection
Federal Trade Commission |
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Roundtable Discussion Regarding FDA and FTC Regulation of Advertising and Promotion of Genetic Technologies |
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Facilitator: Ms. Zellmer |
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Public Comment Session |
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Continued Discussion of Oversight and Pharmacogenetics |
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Genetic Discrimination in Health Insurance and Employment |
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Update on the Status of Federal Legislation to Prohibit Genetic Discrimination Report from the U.S. House of Representatives |
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Ms. Kristin Fitzgerald
Professional Staff Member
U.S. House Committee on Education and the Workforce |
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Roundtable Discussion |
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Facilitator: Ms. Berry |
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