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 *

106 related articles for article (PubMed ID: 36254482)

  • 21. Maintaining Life-saving Testing for Patients With Infectious Diseases: Infectious Diseases Society of America, American Society for Microbiology, and Pan American Society for Clinical Virology Recommendations on the Regulation of Laboratory-developed Tests.
    Caliendo AM; Couturier MR; Ginocchio CC; Hanson KE; Miller MB; Walker KE; Frank GM;
    Clin Infect Dis; 2016 Jul; 63(2):151-4. PubMed ID: 27118790
    [TBL] [Abstract][Full Text] [Related]  

  • 22. US Food and Drug Administration regulatory oversight of laboratory-developed tests: Commentary on the draft guidance.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]  

  • 23. Search for shortcuts on the critical path to market: US FDA perspectives from the diagnostic side.
    Gutman S; Hackett J
    Pharmacogenomics; 2006 Dec; 7(8):1223-7. PubMed ID: 17184209
    [TBL] [Abstract][Full Text] [Related]  

  • 24. "Home brew" laboratory tests.
    Kisner HJ
    Clin Lab Manage Rev; 1999; 13(2):104-6. PubMed ID: 10557868
    [No Abstract]   [Full Text] [Related]  

  • 25. What Every Clinical Virologist Should Know About The VALID Act On Behalf of the Pan-American Society for Clinical Virology Clinical Practice Com.
    Hata J; Madej R; Babady NE
    J Clin Virol; 2021 Aug; 141():104875. PubMed ID: 34243115
    [TBL] [Abstract][Full Text] [Related]  

  • 26. Introduction to in vitro diagnostic device regulatory requirements.
    Day J
    Methods Mol Biol; 2013; 949():103-12. PubMed ID: 23329438
    [TBL] [Abstract][Full Text] [Related]  

  • 27. Long-Term Performance of Laboratory-Developed Liquid Chromatography-Tandem Mass Spectrometry Tests and a Food and Drug Administration-Approved Immunoassay for the Therapeutic Drug Monitoring of Everolimus.
    Schniedewind B; Meyer EJ; Christians U
    Ther Drug Monit; 2020 Jun; 42(3):421-426. PubMed ID: 32427781
    [TBL] [Abstract][Full Text] [Related]  

  • 28. Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.
    Caliendo AM; Hanson KE
    J Clin Microbiol; 2016 Apr; 54(4):829-33. PubMed ID: 26791369
    [TBL] [Abstract][Full Text] [Related]  

  • 29. Regulatory hurdles in bringing an in vitro diagnostic device to market.
    Smith KM; Kates JA
    Clin Chem; 1996 Sep; 42(9):1556-7. PubMed ID: 8787729
    [TBL] [Abstract][Full Text] [Related]  

  • 30. Regulatory approval for new pharmacogenomic tests: a comparative overview.
    Joly Y; Koutrikas G; Tassé AM; Issa A; Carleton B; Hayden M; Rieder MJ; Ramos-Paque E; Avard D
    Food Drug Law J; 2011; 66(1):1-24, i. PubMed ID: 24505844
    [TBL] [Abstract][Full Text] [Related]  

  • 31. Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR).
    Hoffmüller P; Brüggemann M; Eggermann T; Ghoreschi K; Haase D; Hofmann J; Hunfeld KP; Koch K; Meisel C; Michl P; Müller J; Müller C; Rabenau HF; Reinhardt D; Riemenschneider MJ; Sachs UJ; Sack U; Stenzinger A; Streichert T; von Neuhoff N; Weichert W; Weinstock C; Zimmermann S; Spitzenberger F;
    Ger Med Sci; 2021; 19():Doc08. PubMed ID: 34194291
    [TBL] [Abstract][Full Text] [Related]  

  • 32. Impact of VALID Act implementation on mass spectrometry-based clinical proteomic laboratory developed tests.
    Lin Y; Thomas SN
    J Mass Spectrom Adv Clin Lab; 2023 Apr; 28():30-34. PubMed ID: 36865788
    [TBL] [Abstract][Full Text] [Related]  

  • 33. [Impact of the novel in vitro diagnostic regulation (IVDR) of the European Union on pathology laboratories. What's important?].
    Stenzinger A; Weichert W
    Pathologe; 2020 Dec; 41(Suppl 2):129-133. PubMed ID: 33263810
    [TBL] [Abstract][Full Text] [Related]  

  • 34. FDA and CLIA oversight of advanced diagnostics and biomarker tests.
    Terry SF
    Genet Test Mol Biomarkers; 2010 Jun; 14(3):285-7. PubMed ID: 20578940
    [No Abstract]   [Full Text] [Related]  

  • 35. FDA's framework for regulatory oversight of LDTs.
    Pathak B; Terry SF
    Genet Test Mol Biomarkers; 2014 Dec; 18(12):785-6. PubMed ID: 25469801
    [No Abstract]   [Full Text] [Related]  

  • 36. FDA ignores CLIA and moves to regulate clinical laboratories.
    Killingsworth LM
    Clin Chem; 1993 Feb; 39(2):179-80. PubMed ID: 8432005
    [No Abstract]   [Full Text] [Related]  

  • 37. Laboratory testing practices for West Nile virus in the United States.
    Janusz KB; Lehman JA; Panella AJ; Fischer M; Staples E
    Vector Borne Zoonotic Dis; 2011 May; 11(5):597-9. PubMed ID: 20849276
    [TBL] [Abstract][Full Text] [Related]  

  • 38. US manufacturing guideline for IVD products.
    Donawa M
    Med Device Technol; 2000 Oct; 11(8):23-4. PubMed ID: 11185183
    [TBL] [Abstract][Full Text] [Related]  

  • 39. Implementing Regulation (EU) 2017/746 of 5 April 2017 on In vitro Diagnostic Medical Devices (IVDR) in Medical Laboratories, especially in Ophthalmopathology.
    Auw-Hädrich C; Reinhard T; Hädrich J
    Klin Monbl Augenheilkd; 2022 Jul; 239(7):905-912. PubMed ID: 35636459
    [TBL] [Abstract][Full Text] [Related]  

  • 40. Good laboratory practices for biochemical genetic testing and newborn screening for inherited metabolic disorders.
    Centers for Disease Control and Prevention (CDC)
    MMWR Recomm Rep; 2012 Apr; 61(RR-2):1-44. PubMed ID: 22475884
    [TBL] [Abstract][Full Text] [Related]  

    [Previous]   [Next]    [New Search]
    of 6.