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Volumn 87, Issue 4, 2010, Pages 451-456

Understanding FDA regulation of DTC genetic tests within the context of administrative law

Author keywords

[No Author keywords available]

Indexed keywords

CONSUMER; CONSUMER ADVOCACY; FOOD AND DRUG ADMINISTRATION; GENETIC SCREENING; GENETICS; GENOTYPE; LAW; MARKETING; NOTE; PRIORITY JOURNAL; UNITED STATES; GOVERNMENT REGULATION; LEGISLATION AND JURISPRUDENCE; PRODUCT SAFETY;

EID: 77957739460     PISSN: 00029297     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ajhg.2010.09.003     Document Type: Note
Times cited : (19)

References (71)
  • 1
    • 85069259458 scopus 로고    scopus 로고
    • FDA. (2010). Oversight of laboratory-developed tests (LDTs).
    • FDA. (2010). Oversight of laboratory-developed tests (LDTs). http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm212830.htm.
  • 2
    • 85069245746 scopus 로고    scopus 로고
    • U.S. Government Accountability Office (GAO). (2006). GAO 10-847T.
    • U.S. Government Accountability Office (GAO). (2006). GAO 10-847T. http://energycommerce.house.gov/documents/20100722/Kutz.Testimony.07.22.2010. pdf.
  • 3
    • 85069251778 scopus 로고    scopus 로고
    • House Committee on Energy and Commerce Subcommittee. (2010). Direct to Consumer Genetic Testing and Consequences to the Public Health.
    • House Committee on Energy and Commerce Subcommittee. (2010). Direct to Consumer Genetic Testing and Consequences to the Public Health. http://energycommerce.house.gov/index.php?option=com-content&view= article&id=2083:hearing-on-direct-to-consumer-genetic-testing-and-the- consequences-to-the-public-health&catid=133:subcommittee-on-oversight-and- investigations&Itemid=73.
  • 8
    • 58149327181 scopus 로고    scopus 로고
    • The regulation of direct-to-consumer genetic tests
    • J. Kaye The regulation of direct-to-consumer genetic tests Hum. Mol. Genet. 17 no. R2 2008 R180 R183
    • (2008) Hum. Mol. Genet. , vol.17 , Issue.R2
    • Kaye, J.1
  • 11
    • 85069257335 scopus 로고    scopus 로고
    • Sec'y's Advisory Committee on Genetics, Health and Society. (2010). Direct-to-Consumer Genetic Testing.
    • Sec'y's Advisory Committee on Genetics, Health and Society. (2010). Direct-to-Consumer Genetic Testing. http://oba.od.nih.gov/oba/SACGHS/reports/ SCAGHS-DTC-report-2010.pdf.
  • 13
    • 85069244906 scopus 로고    scopus 로고
    • U.S. Const. Art. I., Sec. 1
    • U.S. Const. Art. I., Sec. 1.
  • 14
    • 85069241447 scopus 로고    scopus 로고
    • U.S. Const. Art. I., Sec. 8
    • U.S. Const. Art. I., Sec. 8.
  • 15
    • 85069247176 scopus 로고    scopus 로고
    • U.S. Const. Art. III, Sec. 1
    • U.S. Const. Art. III, Sec. 1.
  • 16
    • 85069241614 scopus 로고    scopus 로고
    • Schor v. CFTC (1986). 478 U.S. 833
    • Schor v. CFTC (1986). 478 U.S. 833.
  • 17
    • 85069244316 scopus 로고    scopus 로고
    • Bimetallic v. State Board of Equalization (1915). 239 U.S. 441
    • Bimetallic v. State Board of Equalization (1915). 239 U.S. 441.
  • 18
    • 85069248130 scopus 로고    scopus 로고
    • Londoner v. Denve (1908). 210 U.S. 373
    • Londoner v. Denve (1908). 210 U.S. 373.
  • 19
    • 85069241630 scopus 로고    scopus 로고
    • Administrative Procedure Act, 5 U.S.C. §551(4-7)
    • Administrative Procedure Act, 5 U.S.C. §551(4-7).
  • 20
    • 85069252694 scopus 로고    scopus 로고
    • SEC v. Chenery (1947). 332 U.S. 194
    • SEC v. Chenery (1947). 332 U.S. 194.
  • 21
    • 85069256947 scopus 로고    scopus 로고
    • Administrative Procedure Act, 5 U.S.C. §553
    • Administrative Procedure Act, 5 U.S.C. §553.
  • 22
    • 85069240532 scopus 로고    scopus 로고
    • Administrative Procedure Act, 5 U.S.C. §§553(c), 556, 557
    • Administrative Procedure Act, 5 U.S.C. §§553(c), 556, 557.
  • 23
    • 85069260306 scopus 로고    scopus 로고
    • Administrative Procedure Act, 5 U.S.C. §554, 556, 557
    • Administrative Procedure Act, 5 U.S.C. §554, 556, 557.
  • 24
    • 85069240340 scopus 로고    scopus 로고
    • Administrative Procedure Act, 5 U.S.C. §559
    • Administrative Procedure Act, 5 U.S.C. §559.
  • 25
    • 85069254267 scopus 로고    scopus 로고
    • J.W. Hampton, Jr. & Co. v. United States (1928). 276 U.S. 394, 409, 48 S. Ct. 348
    • J.W. Hampton, Jr. & Co. v. United States (1928). 276 U.S. 394, 409, 48 S. Ct. 348.
  • 26
    • 85069240209 scopus 로고    scopus 로고
    • Whitman v. American Trucking Associations (2001). 531 U.S. 457, 475, 121 S. Ct. 903, 913
    • Whitman v. American Trucking Associations (2001). 531 U.S. 457, 475, 121 S. Ct. 903, 913.
  • 27
    • 85069239045 scopus 로고    scopus 로고
    • Panama Refining Co. v. Ryan (1935). 293 U.S. 388, 55 S.Ct. 241
    • Panama Refining Co. v. Ryan (1935). 293 U.S. 388, 55 S.Ct. 241.
  • 28
    • 85069246187 scopus 로고    scopus 로고
    • A.L.A. Schecter Poultry Corp. v. United States (1935). 295 U.S. 495, 55 S. Ct. 837
    • A.L.A. Schecter Poultry Corp. v. United States (1935). 295 U.S. 495, 55 S. Ct. 837.
  • 29
    • 85069257384 scopus 로고    scopus 로고
    • Administrative Procedure Act, 5 U.S.C. § 702
    • Administrative Procedure Act, 5 U.S.C. § 702.
  • 30
    • 85069259365 scopus 로고    scopus 로고
    • Administrative Procedure Act, 5 U.S.C. §706(2)(A)
    • Administrative Procedure Act, 5 U.S.C. §706(2)(A).
  • 31
    • 85069248754 scopus 로고    scopus 로고
    • Motor Veh. Mfrs. Ass'n v. State Farm Insurance (1983). 463 U.S. 29
    • Motor Veh. Mfrs. Ass'n v. State Farm Insurance (1983). 463 U.S. 29.
  • 32
    • 85069251894 scopus 로고    scopus 로고
    • Chevron U.S.A., Inc. v. Natural Resources Defence Council, Inc. (1984). 467 U.S. 837
    • Chevron U.S.A., Inc. v. Natural Resources Defence Council, Inc. (1984). 467 U.S. 837.
  • 33
    • 85069259193 scopus 로고    scopus 로고
    • Sanofi-Aventis v. Food and Drug Administration (2010). -F.Supp.2d-, 2010 WL 2899014, 3 (D.D.C. 2010) (internal citations omitted)
    • Sanofi-Aventis v. Food and Drug Administration (2010). -F.Supp.2d-, 2010 WL 2899014, 3 (D.D.C. 2010) (internal citations omitted).
  • 34
    • 85069254280 scopus 로고    scopus 로고
    • MCI Telecommunications. Corp. v. AT&T Co. (1994). 512 U.S. 218
    • MCI Telecommunications. Corp. v. AT&T Co. (1994). 512 U.S. 218.
  • 35
    • 85069249813 scopus 로고    scopus 로고
    • United States v. Mead Corp. (2001). 533 U.S. 218
    • United States v. Mead Corp. (2001). 533 U.S. 218.
  • 36
    • 85069253950 scopus 로고    scopus 로고
    • 21 U.S.C. §301-395
    • -21 U.S.C. §301-395.
  • 37
    • 85069257315 scopus 로고    scopus 로고
    • FDA. How did the Federal Food, Drug, and Cosmetic Act come about?
    • FDA. How did the Federal Food, Drug, and Cosmetic Act come about? http://www.fda.gov/AboutFDA/Basics/ucm214416.htm.
  • 38
    • 85069244240 scopus 로고    scopus 로고
    • FDA.
    • FDA. (2010). When and Why was FDA Formed? http://www.fda.gov/AboutFDA/ Basics/ucm214403.htm.
    • (2010) When and Why Was FDA Formed?
  • 41
    • 85069250715 scopus 로고    scopus 로고
    • 21 U.S.C. §360c et seq
    • -21 U.S.C. §360c et seq.
  • 42
    • 85069245297 scopus 로고    scopus 로고
    • In re Orthopedic Bone Screw Products Liability Litigation, not reported in F. Supp. 2d, 1999 WL 455667, 1 (E.D. Pa. 1999) (citing S. Rep. No. 94-33, at 5 (1975), reprinted in 1976 U.S.C.C.A.N. 1070, 1075)
    • In re Orthopedic Bone Screw Products Liability Litigation, not reported in F. Supp. 2d, 1999 WL 455667, 1 (E.D. Pa. 1999) (citing S. Rep. No. 94-33, at 5 (1975), reprinted in 1976 U.S.C.C.A.N. 1070, 1075).
  • 43
    • 85069256274 scopus 로고    scopus 로고
    • Wyeth Holdings Corporation v. Sebelius (2010). 603 F.3d 1291 (U.S.)
    • Wyeth Holdings Corporation v. Sebelius (2010). 603 F.3d 1291 (U.S.).
  • 44
    • 85069241331 scopus 로고    scopus 로고
    • Riegel v. Medtronics, Inc. (2008). 552 US 312, 328, 128 S.Ct. 999, 1010
    • Riegel v. Medtronics, Inc. (2008). 552 US 312, 328, 128 S.Ct. 999, 1010.
  • 45
    • 85069240498 scopus 로고    scopus 로고
    • Smoking Everywhere, Inc. v. U.S. Food and Drug Admin. (2010). 68 F. Supp. 2d 62, 69 (D.D.C.)
    • Smoking Everywhere, Inc. v. U.S. Food and Drug Admin. (2010). 68 F. Supp. 2d 62, 69 (D.D.C.).
  • 46
    • 85069244563 scopus 로고    scopus 로고
    • Wyeth v. Levine (2009). 129 S. Ct. 1187 (U.S. Vt.)
    • Wyeth v. Levine (2009). 129 S. Ct. 1187 (U.S. Vt.).
  • 47
    • 85069242404 scopus 로고    scopus 로고
    • Yale-New Haven Hosp. v. Leavitt (2006). 470 F.3d 71, 79 (C.A.2 [Conn.])
    • Yale-New Haven Hosp. v. Leavitt (2006). 470 F.3d 71, 79 (C.A.2 [Conn.]).
  • 49
    • 36849010218 scopus 로고    scopus 로고
    • Javitt, G.H. (2007). Food Drug Law J. 62, 617-652. http://www.dnapolicy. org/resources/Javitt-FDLJ.pdf.
    • (2007) Food Drug Law J. , vol.62 , pp. 617-652
    • Javitt, G.H.1
  • 51
    • 80053083959 scopus 로고    scopus 로고
    • Vorhaus, D. (2010). Genomics Law Report. http://www.genomicslawreport. com/index.php/2010/07/15/personal-genomics-goes-to-washington/
    • (2010) Genomics Law Report
    • Vorhaus, D.1
  • 52
    • 85069245434 scopus 로고    scopus 로고
    • FDA. Draft Guidance for Industry, Clinical Laboratories, and FDA Staff - In Vitro Diagnostic Multivariate Index Assays
    • FDA. Draft Guidance for Industry, Clinical Laboratories, and FDA Staff - In Vitro Diagnostic Multivariate Index Assays http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm079148.htm.
  • 53
    • 85069248033 scopus 로고    scopus 로고
    • But Now is At Least 90 Days Away
    • Lakhman, K. 2010. Final IVDMIA Rule Was 'Imminent' This Month, But Now is At Least 90 Days Away. http://www.genomeweb.com/blog/final-ivdmia-rule-was- imminent-month-now-least-90-days-away.
    • (2010) Final IVDMIA Rule Was 'Imminent' This Month
    • Lakhman, K.1
  • 54
    • 80053083959 scopus 로고    scopus 로고
    • Vorhaus, D. (2010). Genomics Law Report http://www.genomicslawreport.com/ index.php/2010/06/15/challenging-the-fda-a-history-lesson-for-dtc-genetics/
    • (2010) Genomics Law Report
    • Vorhaus, D.1
  • 56
    • 80053083959 scopus 로고    scopus 로고
    • Vorhaus, D. (2010). Genomics Law Report. http://www.genomicslawreport. com/index.php/2010/06/16/breaking-fda-moves-to-broadly-regulate-ldts/
    • (2010) Genomics Law Report
    • Vorhaus, D.1
  • 57
    • 77957746410 scopus 로고    scopus 로고
    • FDA Public Meeting; Request for Comments; F.R. 2010-14654
    • FDA. (2010). Oversight of Laboratory Developed Tests; Public Meeting; Request for Comments; F.R. 2010-14654. http://edocket.access.gpo.gov/2010/2010- 14654.htm.
    • (2010) Oversight of Laboratory Developed Tests
  • 58
    • 77957746410 scopus 로고    scopus 로고
    • FDA/CDRH Public Meeting Date July 19-20
    • FDA/CDRH Public Meeting. Oversight of Laboratory Developed Tests (LDTs), Date July 19-20, 2010. http://www.fda.gov/MedicalDevices/NewsEvents/ WorkshopsConferences/ucm212830.htm.
    • (2010) Oversight of Laboratory Developed Tests (LDTs)
  • 60
  • 61
    • 77955626179 scopus 로고    scopus 로고
    • G. Javitt Nature 466 2010 817 818
    • (2010) Nature , vol.466 , pp. 817-818
    • Javitt, G.1
  • 66
    • 85069255143 scopus 로고    scopus 로고
    • Secretary's Advisory Committee On Genetic Testing (SACGT)
    • Secretary's Advisory Committee On Genetic Testing (SACGT). http://oba.od.nih.gov/oba/sacgt/reports/Addendum-final.pdf.
  • 67
    • 85069250707 scopus 로고    scopus 로고
    • FDA 510k Working Group
    • FDA 510k Working Group (2010). CDRH Preliminary Internal Evaluations - Volume I, http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/ UCM220784.pdf.
    • (2010) CDRH Preliminary Internal Evaluations , vol.1
  • 68
    • 85069257009 scopus 로고    scopus 로고
    • Secretary's Advisory Committee on Genetics. Health, and Society
    • Secretary's Advisory Committee on Genetics. Health, and Society. (2008). http://www4.od.nih.gov/oba/sacghs/reports/SACGHS-oversight-report.pdf.
    • (2008)
  • 69
    • 85069239999 scopus 로고    scopus 로고
    • Ray, T. (2010). Pharmacogenomics Reporter. http://www.genomeweb.com/ dxpgx/draft-bill-proposes-fda-create-new-division-review-advanced-personalized- diagnos.
    • (2010) Pharmacogenomics Reporter
    • Ray, T.1
  • 70
    • 77955044484 scopus 로고    scopus 로고
    • FDA
    • FDA. (2009). Device Classification http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm.
    • (2009) Device Classification
  • 71
    • 80051562351 scopus 로고    scopus 로고
    • FDA, Center for Devices and Radiological Health, and Center for Biologics Evaluation and Research
    • FDA, Center for Devices and Radiological Health, and Center for Biologics Evaluation and Research. (2010). Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/UCM071230.pdf.
    • (2010) Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.