Regulating laboratory-developed tests

被引：0
|
作者：
Hal Barron
机构：
[1] Genentech,
来源：
Nature Biotechnology | 2009年 / 27卷
关键词：
D O I：
暂无
中图分类号：
学科分类号：
摘要：
引用
收藏
页码：419 / 419
相关论文
共 50 条
  • [31] The US FDA's proposed rule on laboratory-developed tests: Impacts on clinical laboratory testing
    Smith, Leslie
    Carricaburu, Lisa A.
    Genzen, Jonathan R.
    PRACTICAL LABORATORY MEDICINE, 2024, 40
  • [32] Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests
    Caliendo, Angela M.
    Hanson, Kimberly E.
    JOURNAL OF CLINICAL MICROBIOLOGY, 2016, 54 (04) : 829 - 833
  • [33] 21st-Century Healthcare Policy and the Regulation of Laboratory-Developed Tests
    Caldwell, Lexi
    Terry, Sharon F.
    GENETIC TESTING AND MOLECULAR BIOMARKERS, 2015, 19 (09) : 467 - 468
  • [34] The FDA's proposed rule on laboratory-developed tests: what happens next?
    Genzen, Jonathan R.
    Moser, Karen A.
    LABORATORY MEDICINE, 2024, 55 (02) : 109 - 110
  • [35] Regulatory oversight for research tests and laboratory-developed diagnostics should be more nimble
    Berry, Donna M.
    Parekh, Rulan S.
    Irwin, Meredith S.
    CANADIAN MEDICAL ASSOCIATION JOURNAL, 2019, 191 (50) : E1388 - E1388
  • [36] FDA Regulation of Laboratory-Developed Diagnostic Tests Protect the Public, Advance the Science
    Sharfstein, Joshua
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2015, 313 (07): : 667 - 668
  • [37] Modernizing Federal Oversight of Laboratory-Developed Tests - Toward Safety, Validity, and Utility
    Singhal, Udit
    Horrow, Caroline
    Kesselheim, Aaron S.
    Morgan, Todd M.
    NEW ENGLAND JOURNAL OF MEDICINE, 2023, 389 (19): : 1735 - 1737
  • [38] FDA Oversight of Laboratory-Developed Tests: Is It Necessary, and How Would It Impact Clinical Laboratories?
    Scott, Mitchell G.
    Ashwood, Edward R.
    Annesley, Thomas M.
    Leonard, Debra G. B.
    Burgess, Michael C.
    CLINICAL CHEMISTRY, 2013, 59 (07) : 1017 - 1022
  • [39] Laboratory-Developed Tests in the New European Union 2017/746 Regulation: Opportunities and Risks
    Vogeser, Michael
    Brueggemann, Monika
    Lennerz, Jochen
    Stenzinger, Albrecht
    Gassner, Ulrich M.
    CLINICAL CHEMISTRY, 2022, 68 (01) : 40 - 42
  • [40] Comparison of Laboratory-Developed Tests and FDA-Approved Assays for BRAF, EGFR, and KRAS Testing
    Kim, Annette S.
    Bartley, Angela N.
    Bridge, Julia A.
    Kamel-Reid, Suzanne
    Lazar, Alexander J.
    Lindeman, Neal I.
    Long, Thomas A.
    Merker, Jason D.
    Rai, Alex J.
    Rimm, David L.
    Rothberg, Paul G.
    Vasalos, Patricia
    Moncur, Joel T.
    JAMA ONCOLOGY, 2018, 4 (06) : 838 - 841
12345