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 *

136 related articles for article (PubMed ID: 33929526)

  • 1. Characteristics of Postmarketing Studies for Vaccines Approved by the US Food and Drug Administration, 2006-2020.
    Moneer O; Lee CC; Avorn J; Kesselheim AS
    JAMA Netw Open; 2021 Apr; 4(4):e218530. PubMed ID: 33929526
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Food and Drug Administration regulation and evaluation of vaccines.
    Marshall V; Baylor NW
    Pediatrics; 2011 May; 127 Suppl 1():S23-30. PubMed ID: 21502242
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments.
    Skydel JJ; Luxkaranayagam AT; Dhruva SS; Ross JS; Wallach JD
    JAMA Netw Open; 2019 May; 2(5):e193410. PubMed ID: 31074812
    [TBL] [Abstract][Full Text] [Related]  

  • 4. US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.
    Skydel JJ; Zhang AD; Dhruva SS; Ross JS; Wallach JD
    Clin Trials; 2021 Aug; 18(4):488-499. PubMed ID: 33863236
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study.
    Zeitoun JD; Ross JS; Atal I; Vivot A; Downing NS; Baron G; Ravaud P
    BMJ Open; 2017 Dec; 7(12):e018587. PubMed ID: 29273664
    [TBL] [Abstract][Full Text] [Related]  

  • 6. FDA attempting to overcome major roadblocks in monitoring drug safety.
    Zielinski SL
    J Natl Cancer Inst; 2005 Jun; 97(12):872-3. PubMed ID: 15956645
    [No Abstract]   [Full Text] [Related]  

  • 7. FDA tightens its grip on drug regulation.
    Coombes R
    BMJ; 2007 Feb; 334(7588):290-1. PubMed ID: 17289729
    [TBL] [Abstract][Full Text] [Related]  

  • 8. The Prescription Drug User Fee Act: is a faster Food and Drug Administration always a better Food and Drug Administration?
    Zelenay JL
    Food Drug Law J; 2005; 60(2):261-338. PubMed ID: 16094773
    [No Abstract]   [Full Text] [Related]  

  • 9. Drug safety reform at the FDA--pendulum swing or systematic improvement?
    McClellan M
    N Engl J Med; 2007 Apr; 356(17):1700-2. PubMed ID: 17435081
    [No Abstract]   [Full Text] [Related]  

  • 10. Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration.
    Egilman A; Wallach JD; Puthumana J; Zhang AD; Schwartz JL; Ross JS
    J Gen Intern Med; 2021 Oct; 36(10):3281-3284. PubMed ID: 34131876
    [No Abstract]   [Full Text] [Related]  

  • 11. PDUFA reauthorization--drug safety's golden moment of opportunity?
    Hennessy S; Strom BL
    N Engl J Med; 2007 Apr; 356(17):1703-4. PubMed ID: 17435082
    [No Abstract]   [Full Text] [Related]  

  • 12. 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]  

  • 13. Paying for drug approvals--who's using whom?
    Avorn J
    N Engl J Med; 2007 Apr; 356(17):1697-700. PubMed ID: 17435083
    [No Abstract]   [Full Text] [Related]  

  • 14. Ensuring the safety of genotech drugs through implied warranty theory.
    Serra WM
    Am J Law Med; 1997; 23(2-3):363-81. PubMed ID: 9262761
    [No Abstract]   [Full Text] [Related]  

  • 15. Drug safety: a contrarian's point of view.
    Cobert B
    Food Drug Law J; 2007; 62(3):501-12. PubMed ID: 17915392
    [No Abstract]   [Full Text] [Related]  

  • 16. US Food and Drug Administration-Mandated Postmarketing Studies for High-risk Cardiovascular Devices Approved 2015-2019.
    Hidano D; Dhruva SS; Redberg RF
    JAMA Intern Med; 2022 May; 182(5):556-558. PubMed ID: 35286367
    [TBL] [Abstract][Full Text] [Related]  

  • 17. 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]  

  • 18. Applications for Food and Drug Administration application approval to market a new drug; revision of postmarketing reporting requirements. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2007 Oct; 72(201):58993-9000. PubMed ID: 17966558
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Cause and effect? Assessing postmarketing safety studies as evidence of causation in products liability cases.
    Shea LL; Hanson A; Guglielmetti TM; Levy K
    Food Drug Law J; 2007; 62(3):445-72. PubMed ID: 17915388
    [No Abstract]   [Full Text] [Related]  

  • 20. PLIVA v. Mensing: generic consumers' unfortunate hand.
    Lee SB
    Yale J Health Policy Law Ethics; 2012; 12(2):209-63. PubMed ID: 23175916
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 7.