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從基因檢測臨床與商業化應用發展看基因檢測的規管課題-以美國為例

參考文獻


21 CFR 864.4020
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/ (last visited Feb. 7, 2013)
Draft Guidance for Industry, Climical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays, 2007, http://www.fda.gov/downloads/MedicalDevices/DevicesRegulationandGuidance/GuidanceDocuments/UCM071455.pdf (last visited Jan. 28, 2013).
http://www.genomicslawreport.com/index.php/2010/06/16/breaking-fda-moves-to-broadly-regulate-ldts/ (last visited Feb. 2, 2012).
Federal Register, 2010, 75 (116), 34463 (17 June 2010), available at http://www.genomicslawreport.com/wp-content/uploads/2010/06/Oversight-of-LDTs-Federal-Register-Notice.pdf (last visited Feb. 7, 2013)

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