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 *

486 related articles for article (PubMed ID: 18557224)

  • 1. In search of a coherent framework: options for FDA oversight of genetic tests.
    Javitt GH
    Food Drug Law J; 2007; 62(4):617-52. PubMed ID: 18557224
    [No Abstract]   [Full Text] [Related]  

  • 2. Direct-to-consumer genetic tests, government oversight, and the First Amendment: what the government can (and can't) do to protect the public's health.
    Javitt GH; Stanley E; Hudson K
    Oklahoma Law Rev; 2004; 57(2):251-302. PubMed ID: 15658034
    [No Abstract]   [Full Text] [Related]  

  • 3. The regulation of home diagnostic tests for genetic disorders: can the FDA deny a premarket application on the basis of the device's social impacts?
    Kerouac JD
    J Biolaw Bus; 2002; 5(1):34-43. PubMed ID: 12751500
    [TBL] [Abstract][Full Text] [Related]  

  • 4. 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]  

  • 5. Express preemption and premarket approval under the Medical Device Amendments.
    Scandaglia GJ; Tully TL
    Food Drug Law J; 2004; 59(2):245-64. PubMed ID: 15318395
    [No Abstract]   [Full Text] [Related]  

  • 6. The FDA's humanitarian device exemption program.
    Eydelman MB; Chen EA
    Health Aff (Millwood); 2011 Jun; 30(6):1210-2; author reply 1212. PubMed ID: 21653975
    [No Abstract]   [Full Text] [Related]  

  • 7. The need for increased oversight of genetic testing: a detailed look at the genetic testing process.
    Bonnin DC
    Houst J Health Law Policy; 2003; 4(1):149-80. PubMed ID: 16596751
    [No Abstract]   [Full Text] [Related]  

  • 8. Science and regulation. Regulating direct-to-consumer personal genome testing.
    McGuire AL; Evans BJ; Caulfield T; Burke W
    Science; 2010 Oct; 330(6001):181-2. PubMed ID: 20929761
    [No Abstract]   [Full Text] [Related]  

  • 9. Modernizing device regulation.
    Kretzer RM; Foreman CL; Shuren J
    N Engl J Med; 2010 Jul; 363(2):196-7; author reply 197. PubMed ID: 20653080
    [No Abstract]   [Full Text] [Related]  

  • 10. Pharmaceuticals and Medical Devices: FDA Oversight.
    White RS;
    Issue Brief Health Policy Track Serv; 2017 Dec; 2017():1-33. PubMed ID: 29361662
    [No Abstract]   [Full Text] [Related]  

  • 11. FDA regulation of genetic testing: institutional reluctance and public guardianship.
    Huang A
    Food Drug Law J; 1998; 53(3):555-91. PubMed ID: 10346728
    [No Abstract]   [Full Text] [Related]  

  • 12. Caution flags. Industry fears implications of new FDA process.
    Rhea S
    Mod Healthc; 2010 Jun; 40(26):12-3. PubMed ID: 20632728
    [No Abstract]   [Full Text] [Related]  

  • 13. Modernizing device regulation.
    Garber AM
    N Engl J Med; 2010 Apr; 362(13):1161-3. PubMed ID: 20335575
    [No Abstract]   [Full Text] [Related]  

  • 14. The impact of regulation.
    Magazine AH
    Med Device Technol; 1997 Mar; 8(2):38-44, 46, 48. PubMed ID: 10166366
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Truth in testing laws: a shot in the arm for designer gene tests.
    van Voorhees A
    Health Matrix Clevel; 2006; 16(2):797-829. PubMed ID: 16948256
    [No Abstract]   [Full Text] [Related]  

  • 16. Pharmaceuticals and Medical Devices: FDA Oversight.
    White RS;
    Issue Brief Health Policy Track Serv; 2018 Dec; 2018():1-42. PubMed ID: 30695853
    [No Abstract]   [Full Text] [Related]  

  • 17. Defending substantial equivalence: an argument for the continuing validity of the 510(k) premarket notification process.
    Flaherty JM
    Food Drug Law J; 2008; 63(4):901-27. PubMed ID: 19601388
    [No Abstract]   [Full Text] [Related]  

  • 18. FDA: Gene tests need premarket approval.
    Kuehn BM
    JAMA; 2010 Jul; 304(2):145. PubMed ID: 20628120
    [No Abstract]   [Full Text] [Related]  

  • 19. Conflict between FDA and medicine inevitable.
    Wholey MH; Haller JD
    Diagn Imaging (San Franc); 1995 Oct; 17(10):41-8, 87. PubMed ID: 10159849
    [No Abstract]   [Full Text] [Related]  

  • 20. US market: 2008 priorities.
    Novelli T
    Med Device Technol; 2008; 19(3):58. PubMed ID: 18557412
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 25.