A call for participatory oversight
- PMID: 24506510
- PMCID: PMC3926140
- DOI: 10.1089/gtmb.2014.1552
A call for participatory oversight
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References
-
- Byrne J, Edelson V, Friedland A, Terry SF. (2007) Eyes on the Prize: Truthtelling About Genetic Testing. Washington, DC: Genetic Alliance - PubMed
-
- FDA (2006a) Draft guidance for industry, clinical laboratories, and FDA Staff: In vitro diagnostic multivariate index assays. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/...
-
- FDA (2006b) Draft guidances for industry and FDA Staff: commercially distributed analyte specific reagents. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/...
-
- Horn EJ, Terry SF. (2012) Regulating genetic tests: issues that guide policy decisions. Genet Test Mol Biomarkers 16,1–2 - PubMed
-
- Hudson K. (2003) The vagaries of government regulation. Conscience 24,18. - PubMed
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