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 *

189 related articles for article (PubMed ID: 10179199)

  • 1. FDA import alert: a potentially devastating enforcement tool.
    Basile EM
    Med Device Technol; 1998 Apr; 9(3):34-8. PubMed ID: 10179199
    [TBL] [Abstract][Full Text] [Related]  

  • 2. New FDA draft guidance on premarket submissions.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]  

  • 3. Foreign Establishment Registration and United States agent requirements.
    Nolte CJ; McNamara-Cullinane M
    Med Device Technol; 2002 Dec; 13(10):32-3. PubMed ID: 12575528
    [TBL] [Abstract][Full Text] [Related]  

  • 4. New US agent requirements.
    Donawa M
    Med Device Technol; 2002; 13(1):35-7. PubMed ID: 11921780
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Foreign establishment registration and listing. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2001 Nov; 66(228):59138-61. PubMed ID: 11776289
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Final FDA inspection manual.
    Donawa M
    Med Device Technol; 2001 Apr; 12(3):29-32. PubMed ID: 11547684
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Use and recognition of consensus standards in US premarket submissions.
    Donawa ME
    Med Device Technol; 1999 Mar; 10(2):13-7. PubMed ID: 10387610
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Differing definitions of manufacturer.
    Donawa ME
    Med Device Technol; 1998; 9(6):14-7. PubMed ID: 10182120
    [TBL] [Abstract][Full Text] [Related]  

  • 9. US importer and distributor requirements.
    Donawa M
    Med Device Technol; 2005 Jun; 16(5):25-7. PubMed ID: 15984543
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Medical devices; intent to initiate proceedings to establish effective dates of requirement for premarket approval for 31 class III preamendments devices--FDA. Advance notice of proposed rulemaking.
    Fed Regist; 1989 Jan; 54(4):550-2. PubMed ID: 10291347
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Pharmaceuticals and medical devices: FDA oversight. End-of-year issue brief.
    Chaps NA
    Issue Brief Health Policy Track Serv; 2008 Jan; ():1-18. PubMed ID: 18345557
    [No Abstract]   [Full Text] [Related]  

  • 12. Europe and FDA agree to limited inspections.
    Fox JL
    Nat Biotechnol; 1997 Aug; 15(8):714-5. PubMed ID: 9333519
    [No Abstract]   [Full Text] [Related]  

  • 13. Medical devices; medical device reporting. Direct final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2005 Feb; 70(38):9516-28. PubMed ID: 15736310
    [TBL] [Abstract][Full Text] [Related]  

  • 14. The new FDA combination products programme.
    Donawa M
    Med Device Technol; 2002 Oct; 13(8):25-8. PubMed ID: 12416330
    [TBL] [Abstract][Full Text] [Related]  

  • 15. FDA considering new rules that may clamp down on early showings of works in progress.
    Wagner M
    Mod Healthc; 1992 Aug; 22(32):34. PubMed ID: 10119785
    [No Abstract]   [Full Text] [Related]  

  • 16. Understanding US labelling requirements.
    Donawa M
    Med Device Technol; 2005 Sep; 16(7):21-3. PubMed ID: 16259155
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Beyond the US submisson process.
    Donawa M
    Med Device Technol; 2004 Apr; 15(3):30-2. PubMed ID: 15255536
    [TBL] [Abstract][Full Text] [Related]  

  • 18. 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]  

  • 19. Safe and effective medical devices--everyone's responsibility.
    Franke KA
    Gastroenterol Nurs; 1992 Apr; 14(5):245-8. PubMed ID: 1581379
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Trends and events in FDA regulation of medical devices over the last fifty years.
    Munsey RR
    Food Drug Law J; 1995; 50 Spec():163-77. PubMed ID: 10343041
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 10.