CYSTIC FIBROSIS;
FOOD AND DRUG ADMINISTRATION;
GENETIC SCREENING;
GENETICS;
GENOMICS;
GOVERNMENT;
HEALTH CARE PERSONNEL;
MARFAN SYNDROME;
REVIEW;
UNITED STATES;
GENETIC TESTING;
GOVERNMENT REGULATION;
HUMANS;
INTERNET;
PHARMACEUTICAL SERVICES;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
FDA. Letter to Pathway Genomics Corporation concerning the Pathway Genomics genetic health report. (Accessed September
FDA. Letter to Pathway Genomics Corporation concerning the Pathway Genomics genetic health report. http://www. fda.gov/MedicalDevices/Resources forYou/Industry/ucm211866.htm (Accessed September 2010).
(2010)
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FDA FDA/CDRH public meeting: Oversight of laboratory developed tests (LDTs), date July 19-20, (Accessed September 2010)
FDA. FDA/CDRH public meeting: Oversight of laboratory developed tests (LDTs), date July 19-20, 2010. http://www.fda.gov/MedicalDevices/NewsEvents/ WorkshopsConferences/ucm212830.htm (Accessed September 2010).
(2010)
3
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U.S. House of Representatives Committee on Energy and Commerce. Hearing on "Direct-To- Consumer Genetic Testing and the Consequences to the Public Health." (Accessed September
U.S. House of Representatives Committee on Energy and Commerce. Hearing on "Direct-To- Consumer Genetic Testing and the Consequences to the Public Health."http://energycommerce.house.gov/index.php?option-com- content&view-article&id-2083:hearing-on-direct-to-consumergenetic- testing-and-the-consequences-to-the-publichealth&catid-133: subcommittee-on-oversight-andinvestigations&Itemid-73 (Accessed September 2010).
(2010)
4
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U.S. GAO. Direct-to-consumer genetic tests: Misleading test results are further complicated by deceptive marketing and other questionable practices. Accessed September
U.S. GAO. Direct-to-consumer genetic tests: Misleading test results are further complicated by deceptive marketing and other questionable practices. http://www.gao.gov/products/GAO-10-847T (Accessed September 2010).
(2010)
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Which way for genetic-test regulation? Leave test interpretation to specialists
Beaudet AL. Which way for genetic-test regulation? Leave test interpretation to specialists. Nature 2010;466:816-7.
U.S. system of oversight of genetic testing: A response to the charge of the Secretary of Health and Human Services. Accessed September
The Secretary's Advisory Committee on Genetics, Health, and Society. U.S. system of oversight of genetic testing: A response to the charge of the Secretary of Health and Human Services. http://oba.od.nih.gov/oba/SACGHS/ reports/SACGHS-oversight-report.pdf (Accessed September 2010).
