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 *

467 related articles for article (PubMed ID: 17915401)

  • 1. Medical device safety: FDA's postmarket transformation initiative.
    Schultz D
    Food Drug Law J; 2007; 62(3):593-6. PubMed ID: 17915401
    [No Abstract]   [Full Text] [Related]  

  • 2. FDA's expanding postmarket authority to monitor and publicize food and consumer health product risks: the need for procedural safeguards to reduce "transparency" policy harms in the post-9/11 regulatory environment.
    Roller ST; Pippins RR; Ngai JW
    Food Drug Law J; 2009; 64(3):577-98. PubMed ID: 19999646
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Medical devices post-approval studies program: vision, strategies, challenges and opportunities.
    Marinac-Dabic D; Bonhomme M; Loyo-Berrios N; Gross T; Ciperson R; Gardner S; Marcarelli M
    Food Drug Law J; 2007; 62(3):597-604. PubMed ID: 17915402
    [No Abstract]   [Full Text] [Related]  

  • 4. MedWatch. FDA's 'heads up' on medical product safety.
    Henkel J
    FDA Consum; 1998; 32(6):10-2, 15. PubMed ID: 9854445
    [No Abstract]   [Full Text] [Related]  

  • 5. Postmarket surveillance. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2002 Jun; 67(109):38878-92. PubMed ID: 12053947
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Medical device recalls from 2004 to 2006: a focus on Class I recalls.
    Villarraga ML; Guerin HL; Lam T
    Food Drug Law J; 2007; 62(3):581-92. PubMed ID: 17915400
    [No Abstract]   [Full Text] [Related]  

  • 7. The Safe Medical Devices Act of 1990--FDA. Notice.
    Fed Regist; 1991 Apr; 56(66):14111-3. PubMed ID: 10111151
    [TBL] [Abstract][Full Text] [Related]  

  • 8. An overview of FDA medical device regulation as it relates to deep brain stimulation devices.
    Peña C; Bowsher K; Costello A; De Luca R; Doll S; Li K; Schroeder M; Stevens T
    IEEE Trans Neural Syst Rehabil Eng; 2007 Sep; 15(3):421-4. PubMed ID: 17894274
    [TBL] [Abstract][Full Text] [Related]  

  • 9. The FDA and drug safety: a proposal for sweeping changes.
    Furberg CD; Levin AA; Gross PA; Shapiro RS; Strom BL
    Arch Intern Med; 2006 Oct; 166(18):1938-42. PubMed ID: 17030825
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Not enough warning. GAO report finds FDA's medical device monitoring lacking.
    Hensley S
    Mod Healthc; 1997 Mar; 27(10):102, 104. PubMed ID: 10165267
    [No Abstract]   [Full Text] [Related]  

  • 11. What you should know about device recalls.
    OR Manager; 2002 Apr; 18(4):21. PubMed ID: 11962164
    [No Abstract]   [Full Text] [Related]  

  • 12. Risk assessment and management as related to evaluation of medical devices: a view from the FDA.
    Callahan TJ; Marlowe DE
    J Long Term Eff Med Implants; 1993; 3(4):269-76. PubMed ID: 10172029
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Facilities' responsibilities after notification of a medical device hazard or recall.
    Health Devices; 2004 Sep; 33(9):339. PubMed ID: 15532863
    [No Abstract]   [Full Text] [Related]  

  • 14. The U.S. FDA's involvement in the development and utilization of D11.40's standards on rubber consumer products.
    Lin CS; Herman C
    Stand News; 2003 Jul; 31(7):38-41. PubMed ID: 12882219
    [No Abstract]   [Full Text] [Related]  

  • 15. Postmarket surveillance for medical devices: America's new strategy.
    Normand SL; Hatfield L; Drozda J; Resnic FS
    BMJ; 2012 Oct; 345():e6848. PubMed ID: 23060660
    [No Abstract]   [Full Text] [Related]  

  • 16. Challenges in regulating breakthrough medical devices.
    Muni NI; Gross TP; Boam AB; Wang S; Zuckerman BD
    Food Drug Law J; 2005; 60(2):137-42. PubMed ID: 16097092
    [No Abstract]   [Full Text] [Related]  

  • 17. Device tracking: user facility responsibilities.
    Shepherd N
    J Clin Eng; 1993; 18(5):441-52. PubMed ID: 10129809
    [TBL] [Abstract][Full Text] [Related]  

  • 18. The Food and Drug Administration's regulation of risk disclosure for implantable cardioverter defibrillators: has technology outpaced the Agency's regulatory framework?
    Basile EM; Lorell BH
    Food Drug Law J; 2006; 61(2):251-72. PubMed ID: 16903031
    [No Abstract]   [Full Text] [Related]  

  • 19. Achieving medical device safety in an era of globalization.
    Meritz JK; White TL
    Food Drug Law J; 2008; 63(3):647-55. PubMed ID: 19031664
    [No Abstract]   [Full Text] [Related]  

  • 20. FDA's cloning report bypasses ethics, exposes European dilemma.
    Vermij P
    Nat Biotechnol; 2007 Jan; 25(1):7-8. PubMed ID: 17211377
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 24.