BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

414 related articles for article (PubMed ID: 17039953)

  • 1. Strategic planning for U.S. premarket approval submissions.
    Donawa M
    Med Device Technol; 2006 Sep; 17(7):21-3. PubMed ID: 17039953
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Guidance on submitting quality system information.
    Donawa ME
    Med Device Technol; 2004 Mar; 15(2):24-7. PubMed ID: 15154336
    [TBL] [Abstract][Full Text] [Related]  

  • 3. New FDA draft guidance on premarket submissions.
    Donawa ME
    Med Device Technol; 1999 Oct; 10(8):12-4. PubMed ID: 10724773
    [TBL] [Abstract][Full Text] [Related]  

  • 4. An important step forward in the global harmonisation of premarket review programmes.
    Donawa M
    Med Device Technol; 2001 Sep; 12(7):28-30. PubMed ID: 12938557
    [TBL] [Abstract][Full Text] [Related]  

  • 5. The US medical device bundling policy.
    Donawa M
    Med Device Technol; 2004 Nov; 15(9):25-7. PubMed ID: 16231784
    [TBL] [Abstract][Full Text] [Related]  

  • 6. FDA user fee and Modernisation Act.
    Donawa M
    Med Device Technol; 2002 Dec; 13(10):27-9. PubMed ID: 12575526
    [TBL] [Abstract][Full Text] [Related]  

  • 7. FDA pilot programme in support of global harmonisation.
    Donawa ME
    Med Device Technol; 2003 Nov; 14(9):32-4. PubMed ID: 14682021
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Successful recruitment for medical device clinical studies.
    Donawa M
    Med Device Technol; 2004 Oct; 15(8):25-7. PubMed ID: 16225270
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Gastroenterology and urology devices; effective date of requirement for premarket approval of the implanted mechanical/hydraulic urinary continence device. Food and Drug Administration, HHS. Final rule.
    Fed Regist; 2000 Sep; 65(187):57726-32. PubMed ID: 11503643
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Medical devices containing materials derived from animal sources (except for in vitro diagnostic devices), guidance for FDA reviewers and industry; availability--FDA. Notice.
    Fed Regist; 1998 Nov; 63(215):60009-10. PubMed ID: 10187389
    [TBL] [Abstract][Full Text] [Related]  

  • 11. 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]  

  • 12. The Center for Devices and Radiological health: an update.
    Donawa M
    Med Device Technol; 2001 Dec; 12(10):24, 26-7. PubMed ID: 15966141
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Design controls.
    Bartoo G
    IEEE Eng Med Biol Mag; 2003; 22(2):112-4. PubMed ID: 12733469
    [No Abstract]   [Full Text] [Related]  

  • 14. Orthopedic devices; effective data of requirement for premarket approval for hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2004 Oct; 69(191):59132-4. PubMed ID: 15460583
    [TBL] [Abstract][Full Text] [Related]  

  • 15. 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]  

  • 16. Inappropriate attack on device development.
    Somberg JC
    Am J Ther; 2011; 18(2):91. PubMed ID: 21393999
    [No Abstract]   [Full Text] [Related]  

  • 17. When to conduct a clinical trial.
    Boutrand JP
    Med Device Technol; 2004 Oct; 15(8):28-31. PubMed ID: 16225271
    [TBL] [Abstract][Full Text] [Related]  

  • 18. US regulation of combination products.
    Donawa M
    Med Device Technol; 2009 Oct; 20(6):22, 24-5. PubMed ID: 20302139
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Will new FDA rules hasten device approval?
    Hosp Mater Manage; 2003 Jul; 28(7):2, 16. PubMed ID: 12889277
    [No Abstract]   [Full Text] [Related]  

  • 20. Obstetric and gynecology devices; effective date of requirement for premarket approval for glans sheath devices. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2002 Jun; 67(115):40848-9. PubMed ID: 12068899
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 21.