These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

130 related articles for article (PubMed ID: 38167766)

  • 1. Point: The Need for Additional FDA Regulations in Laboratory Medicine.
    Konnick EQ
    J Appl Lab Med; 2024 Jan; 9(1):151-154. PubMed ID: 38167766
    [No Abstract]   [Full Text] [Related]  

  • 2. Looming regulations and FDA oversight mean an uncertain reimbursement climate in 2016.
    Wolf R
    MLO Med Lab Obs; 2016 May; 48(5):26-7. PubMed ID: 27323455
    [No Abstract]   [Full Text] [Related]  

  • 3. FDA regulation of LDTs--an update.
    Jones PM
    MLO Med Lab Obs; 2015 Sep; 47(9):18-9. PubMed ID: 26495591
    [No Abstract]   [Full Text] [Related]  

  • 4. FDA regulation of laboratory-developed diagnostic tests: protect the public, advance the science.
    Sharfstein J
    JAMA; 2015 Feb; 313(7):667-8. PubMed ID: 25560381
    [No Abstract]   [Full Text] [Related]  

  • 5. FDA oversight of laboratory-developed tests: is it necessary, and how would it impact clinical laboratories?
    Scott MG; Ashwood ER; Annesley TM; Leonard DG; Burgess MC
    Clin Chem; 2013 Jul; 59(7):1017-22. PubMed ID: 23536512
    [No Abstract]   [Full Text] [Related]  

  • 6. Counterpoint: Why the FDA Should Not Regulate Laboratory-Developed Tests.
    Leung ML
    J Appl Lab Med; 2024 Jan; 9(1):155-158. PubMed ID: 38167755
    [No Abstract]   [Full Text] [Related]  

  • 7. FDA announces plans to regulate LDTs.
    Cancer Discov; 2014 Nov; 4(11):1250. PubMed ID: 25367935
    [No Abstract]   [Full Text] [Related]  

  • 8. "Research use only" reagents: is there an imperative for increased FDA oversight?
    O'Leary TJ
    Clin Chem; 2011 Dec; 57(12):1681-3. PubMed ID: 21998341
    [No Abstract]   [Full Text] [Related]  

  • 9. FDA Announces Increased Oversight of Some Diagnostic Laboratory Tests.
    Harris E
    JAMA; 2024 Jun; 331(24):2071. PubMed ID: 38819803
    [No Abstract]   [Full Text] [Related]  

  • 10. Laboratory-developed tests are not the practice of medicine.
    Allen JS
    MLO Med Lab Obs; 2015 Sep; 47(9):46. PubMed ID: 26495599
    [No Abstract]   [Full Text] [Related]  

  • 11. US Food and Drug Administration regulatory oversight of laboratory-developed tests: Commentary on the draft guidance.
    Sidawy MK
    Cancer Cytopathol; 2015 Oct; 123(10):573-5. PubMed ID: 26042383
    [No Abstract]   [Full Text] [Related]  

  • 12. Tighter gene tests.
    Fox J
    Nat Biotechnol; 2008 Jul; 26(7):721. PubMed ID: 18612277
    [No Abstract]   [Full Text] [Related]  

  • 13. Does Increased Regulation of Laboratory-Developed Tests (LDTs) Make Sense? The Harms of Over-Regulation.
    Hortin GL
    J Appl Lab Med; 2024 May; 9(3):646-650. PubMed ID: 38332567
    [No Abstract]   [Full Text] [Related]  

  • 14. Theranos Experience Exposes Weaknesses in FDA Regulatory Discretion.
    Jotwani R; Boumil M; Salem D; Wetterhahn M; Beninger P
    Clin Pharmacol Drug Dev; 2017 Sep; 6(5):433-438. PubMed ID: 28741304
    [No Abstract]   [Full Text] [Related]  

  • 15. The FDA's Experience with Covid-19 Antibody Tests.
    Shuren J; Stenzel T
    N Engl J Med; 2021 Feb; 384(7):592-594. PubMed ID: 33605568
    [No Abstract]   [Full Text] [Related]  

  • 16. FDA Oversight of Laboratory-Developed Tests: Where Are We Now?
    Gatter K
    Arch Pathol Lab Med; 2017 Jun; 141(6):746-748. PubMed ID: 28557601
    [No Abstract]   [Full Text] [Related]  

  • 17. How will the FDA impact the laboratory developed test?
    Davis J; Wentz J
    Clin Lab Sci; 2007; 20(3):130-1. PubMed ID: 17691668
    [No Abstract]   [Full Text] [Related]  

  • 18. FDA oversight of laboratory-developed tests will facilitate adoption of pharmacogenetic testing into routine clinical care.
    Hillebrenner E; Litwack E; Bradley P; Donigan K; Lowe T; Serrano K; Kelm K; Mansfield E; Gutierrez A
    J Clin Pharmacol; 2015 Jul; 55(7):728-30. PubMed ID: 26053648
    [No Abstract]   [Full Text] [Related]  

  • 19. Laboratory developed tests: what may be coming.
    Jones PM
    MLO Med Lab Obs; 2012 Oct; 44(10):24, 26. PubMed ID: 23091959
    [No Abstract]   [Full Text] [Related]  

  • 20. US Food and Drug Administration Perspectives on Clinical Mass Spectrometry.
    Lathrop JT; Jeffery DA; Shea YR; Scholl PF; Chan MM
    Clin Chem; 2016 Jan; 62(1):41-7. PubMed ID: 26553791
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 7.