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 *

166 related articles for article (PubMed ID: 29971404)

  • 1. Reviving the FDA's Authority to Publicly Explain Why New Drug Applications Are Approved or Rejected.
    Herder M
    JAMA Intern Med; 2018 Aug; 178(8):1013-1014. PubMed ID: 29971404
    [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. Roadmap for revitalization?
    Nat Biotechnol; 2007 Oct; 25(10):1061. PubMed ID: 17921973
    [No Abstract]   [Full Text] [Related]  

  • 4. Bolstering the FDA's drug-safety authority.
    Schultz WB
    N Engl J Med; 2007 Nov; 357(22):2217-9. PubMed ID: 18046024
    [No Abstract]   [Full Text] [Related]  

  • 5. US Senate passes FDA Revitalization Act.
    Guthrie P
    CMAJ; 2007 Jul; 177(1):23. PubMed ID: 17606930
    [No Abstract]   [Full Text] [Related]  

  • 6. Science and regulation. FDA's approach to regulation of products of nanotechnology.
    Hamburg MA
    Science; 2012 Apr; 336(6079):299-300. PubMed ID: 22517845
    [No Abstract]   [Full Text] [Related]  

  • 7. Regulatory experts debate FDA's authority.
    Young D
    Am J Health Syst Pharm; 2007 May; 64(9):910, 912. PubMed ID: 17468140
    [No Abstract]   [Full Text] [Related]  

  • 8. FDA's monitoring of postmarketing studies probed.
    Young D
    Am J Health Syst Pharm; 2006 Aug; 63(16):1485-6. PubMed ID: 16896075
    [No Abstract]   [Full Text] [Related]  

  • 9. Postmarketing studies for approved human drug and licensed biological products; status reports. Food and Drug Administration, HHS. Final rule.
    Fed Regist; 2000 Oct; 65(210):64607-19. PubMed ID: 11503687
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Off-label use of medical devices in radiology: regulatory standards and recent developments.
    Smith JJ
    J Am Coll Radiol; 2010; 7(2):115-9. PubMed ID: 20142085
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Preserve the FDA's authority.
    Guharoy R
    Am J Health Syst Pharm; 1996 Nov; 53(21):2636, 2638. PubMed ID: 8913395
    [No Abstract]   [Full Text] [Related]  

  • 12. Lawsuit seeks access to data from hepatitis C drug trial.
    McCarthy M
    BMJ; 2015 Jun; 350():h3564. PubMed ID: 26126508
    [No Abstract]   [Full Text] [Related]  

  • 13. Review of Transporter-Related Postmarketing Requirement or Postmarketing Commitment Studies.
    Fan Y; Sun B; Agarwal S; Zhang L
    J Clin Pharmacol; 2016 Jul; 56 Suppl 7():S193-204. PubMed ID: 27385175
    [TBL] [Abstract][Full Text] [Related]  

  • 14. The balance of benefit and safety of rosiglitazone: important lessons for our system of drug development and postmarketing assessment.
    Califf RM; Kramer JM
    Pharmacoepidemiol Drug Saf; 2008 Aug; 17(8):782-6. PubMed ID: 18655016
    [No Abstract]   [Full Text] [Related]  

  • 15. 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]  

  • 16. Does $760 m a year of industry funding affect the FDA's drug approval process?
    Wolfe SM
    BMJ; 2014 Aug; 349():g5012. PubMed ID: 25096994
    [No Abstract]   [Full Text] [Related]  

  • 17. US Congress considers new tracking system for medical devices after excessive recalls.
    Epstein K
    BMJ; 2012 Apr; 344():e2915. PubMed ID: 22529316
    [No Abstract]   [Full Text] [Related]  

  • 18. FDA's Unimproved Enforcement of Postmarketing Requirements and Commitments: Implications for Providers and Patients.
    Dauner DG; Dauner KN; Peterson ALH
    Res Social Adm Pharm; 2020 Jun; 16(6):844-847. PubMed ID: 31812502
    [TBL] [Abstract][Full Text] [Related]  

  • 19. The FDA's poor oversight of postmarketing studies.
    Lancet; 2009 Nov; 374(9701):1568. PubMed ID: 19897111
    [No Abstract]   [Full Text] [Related]  

  • 20. Regulating Off-Label Promotion - A Critical Test.
    Robertson C; Kesselheim AS
    N Engl J Med; 2016 Dec; 375(24):2313-2315. PubMed ID: 27805841
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 9.