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 *

170 related articles for article (PubMed ID: 34379128)

  • 1. Canadian Regulatory and Health Technology Assessment for Malignant Hematology and Oncology Indications Compared With the US Food and Drug Administration Accelerated Approval Program.
    Ho C; Lim HJ; Regier DA
    JAMA Netw Open; 2021 Aug; 4(8):e2120301. PubMed ID: 34379128
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016.
    Zhou J; Vallejo J; Kluetz P; Pazdur R; Kim T; Keegan P; Farrell A; Beaver JA; Sridhara R
    J Natl Cancer Inst; 2019 May; 111(5):449-458. PubMed ID: 30085269
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Drug approval: future aspects of the FDA.
    Skelly JP
    Methods Find Exp Clin Pharmacol; 1998; 20(6):527-37. PubMed ID: 9789876
    [No Abstract]   [Full Text] [Related]  

  • 4. The regulation of drugs and biologics: fifty years into the future.
    Kuhlik BN
    Food Drug Law J; 2000; 55(1):21-5. PubMed ID: 12269358
    [No Abstract]   [Full Text] [Related]  

  • 5. Tackling Cost: A Prescription for Spending Wisely.
    Tempero M
    J Natl Compr Canc Netw; 2019 Jun; 17(6):633. PubMed ID: 31200360
    [No Abstract]   [Full Text] [Related]  

  • 6. FDA treads delicate line between safety and speed.
    Oncology (Williston Park); 1999 Jan; 13(1):16. PubMed ID: 10027195
    [No Abstract]   [Full Text] [Related]  

  • 7. Regulatory watch: Why do oncology drugs fail to gain US regulatory approval?
    Khozin S; Liu K; Jarow JP; Pazdur R
    Nat Rev Drug Discov; 2015 Jul; 14(7):450-1. PubMed ID: 26000722
    [No Abstract]   [Full Text] [Related]  

  • 8. Oncology drug development: United States Food and Drug Administration perspective.
    Hirschfeld S; Pazdur R
    Crit Rev Oncol Hematol; 2002 May; 42(2):137-43. PubMed ID: 12007971
    [TBL] [Abstract][Full Text] [Related]  

  • 9. US Food and Drug Administration pushed to change.
    McCarthy M
    Lancet; 2006 May; 367(9523):1643-4. PubMed ID: 16718861
    [No Abstract]   [Full Text] [Related]  

  • 10. Accelerated approval and oncology drug development timelines.
    Lanthier ML; Sridhara R; Johnson JR; Farrell A; Keegan P; Justice R; Pazdur R
    J Clin Oncol; 2010 May; 28(14):e226-7; author reply e228. PubMed ID: 20194846
    [No Abstract]   [Full Text] [Related]  

  • 11. A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.
    Beaver JA; Howie LJ; Pelosof L; Kim T; Liu J; Goldberg KB; Sridhara R; Blumenthal GM; Farrell AT; Keegan P; Pazdur R; Kluetz PG
    JAMA Oncol; 2018 Jun; 4(6):849-856. PubMed ID: 29494733
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Accelerated approval of oncology products: the food and drug administration experience.
    Johnson JR; Ning YM; Farrell A; Justice R; Keegan P; Pazdur R
    J Natl Cancer Inst; 2011 Apr; 103(8):636-44. PubMed ID: 21422403
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Use of multiple endpoints and approval paths depicts a decade of FDA oncology drug approvals.
    Shea MB; Roberts SA; Walrath JC; Allen JD; Sigal EV
    Clin Cancer Res; 2013 Jul; 19(14):3722-31. PubMed ID: 23665737
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Patent watch: post-approval testing shielded from patent infringement.
    Harrison C
    Nat Rev Drug Discov; 2012 Sep; 11(9):666. PubMed ID: 23097768
    [No Abstract]   [Full Text] [Related]  

  • 15. Regulatory watch: Innovative drug availability in China.
    Shao L; Xu L; Li Q; Chakravarthy R; Yang Z; Kaitin KI
    Nat Rev Drug Discov; 2016 Nov; 15(11):739-740. PubMed ID: 27765941
    [No Abstract]   [Full Text] [Related]  

  • 16. Flexibility and innovation in the FDA's novel regulatory approval strategies for hematologic drugs.
    Farrell AT; Goldberg KB; Pazdur R
    Blood; 2017 Sep; 130(11):1285-1289. PubMed ID: 28774876
    [No Abstract]   [Full Text] [Related]  

  • 17. Regulatory watch: FDA guidance on co-developing investigational drugs.
    Nat Rev Drug Discov; 2011 Feb; 10(2):86. PubMed ID: 21283094
    [No Abstract]   [Full Text] [Related]  

  • 18. They are from the government and they really are here to help you.
    Woosley RL
    J Clin Pharmacol; 2008 Feb; 48(2):142-3. PubMed ID: 18199889
    [No Abstract]   [Full Text] [Related]  

  • 19. Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.
    Sridhara R; Johnson JR; Justice R; Keegan P; Chakravarty A; Pazdur R
    J Natl Cancer Inst; 2010 Feb; 102(4):230-43. PubMed ID: 20118413
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016.
    Ladanie A; Schmitt AM; Speich B; Naudet F; Agarwal A; Pereira TV; Sclafani F; Herbrand AK; Briel M; Martin-Liberal J; Schmid T; Ewald H; Ioannidis JPA; Bucher HC; Kasenda B; Hemkens LG
    JAMA Netw Open; 2020 Nov; 3(11):e2024406. PubMed ID: 33170262
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 9.