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 *

215 related articles for article (PubMed ID: 24747238)

  • 1. Drug development in serious diseases: the new "breakthrough therapy" designation.
    Woodcock J
    Clin Pharmacol Ther; 2014 May; 95(5):483-5. PubMed ID: 24747238
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Expediting drug development--the FDA's new "breakthrough therapy" designation.
    Sherman RE; Li J; Shapley S; Robb M; Woodcock J
    N Engl J Med; 2013 Nov; 369(20):1877-80. PubMed ID: 24224621
    [TBL] [Abstract][Full Text] [Related]  

  • 3. The Impact of Breakthrough Therapy Designation on Development Strategies and Timelines for Nononcology Drugs and Vaccines.
    Poirier AF; Murphy WR
    Clin Pharmacol Ther; 2016 Dec; 100(6):603-605. PubMed ID: 27513678
    [TBL] [Abstract][Full Text] [Related]  

  • 4. New FDA breakthrough-drug category--implications for patients.
    Darrow JJ; Avorn J; Kesselheim AS
    N Engl J Med; 2014 Mar; 370(13):1252-8. PubMed ID: 24670173
    [No Abstract]   [Full Text] [Related]  

  • 5. FDA Modernization Act: implications for oncology.
    Morris L
    Oncology (Williston Park); 1998 Nov; 12(11A):139-41. PubMed ID: 10028506
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Finding value in the U.S. Food and Drug Administration's Fast Track program.
    Reichert JM; Rochon SL; Zhang BD
    Drug News Perspect; 2009; 22(1):53-8. PubMed ID: 19209299
    [TBL] [Abstract][Full Text] [Related]  

  • 7. FDA designations for therapeutics and their impact on drug development and regulatory review outcomes.
    Kesselheim AS; Darrow JJ
    Clin Pharmacol Ther; 2015 Jan; 97(1):29-36. PubMed ID: 25670381
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Expedited Programs for Serious Conditions: An Update on Breakthrough Therapy Designation.
    Kwok M; Foster T; Steinberg M
    Clin Ther; 2015 Sep; 37(9):2104-20. PubMed ID: 26297571
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Establishing a list of qualifying pathogens under the Food and Drug Administration Safety and Innovation Act. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2014 Jun; 79(108):32464-81. PubMed ID: 24908687
    [TBL] [Abstract][Full Text] [Related]  

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

  • 11. Breakthrough-Therapy Designation - An FDA Perspective.
    Corrigan-Curay J; McKee AE; Stein P
    N Engl J Med; 2018 Apr; 378(15):1457-1458. PubMed ID: 29641963
    [No Abstract]   [Full Text] [Related]  

  • 12. Food and drug administration expanded access to treatment: implications for oncology patients.
    Freedman RS; Markman M
    Cancer; 2007 Jun; 109(11):2157-60. PubMed ID: 17450587
    [No Abstract]   [Full Text] [Related]  

  • 13. New drug, antibiotic, and biological drug product regulations; accelerated approval--FDA. Final rule.
    Fed Regist; 1992 Dec; 57(239):58942-60. PubMed ID: 10123232
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Balancing US patent and FDA approval processes: strategically optimizing market exclusivity.
    Fernandez DS; Huie JT
    Drug Discov Today; 2004 Jun; 9(12):509-12. PubMed ID: 15183155
    [No Abstract]   [Full Text] [Related]  

  • 15. 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]  

  • 16. New FDA breakthrough-drug category--implications for patients.
    Ricart AD
    N Engl J Med; 2014 Jul; 371(1):89. PubMed ID: 24988580
    [No Abstract]   [Full Text] [Related]  

  • 17. New FDA breakthrough-drug category--implications for patients.
    Velleca M
    N Engl J Med; 2014 Jul; 371(1):88-9. PubMed ID: 24988579
    [No Abstract]   [Full Text] [Related]  

  • 18. New FDA breakthrough-drug category--implications for patients.
    Murray BE
    N Engl J Med; 2014 Jul; 371(1):88. PubMed ID: 24988578
    [No Abstract]   [Full Text] [Related]  

  • 19. New FDA breakthrough-drug category--implications for patients.
    McClellan M; Sigal E
    N Engl J Med; 2014 Jul; 371(1):87-8. PubMed ID: 24988577
    [No Abstract]   [Full Text] [Related]  

  • 20. New FDA breakthrough-drug category--implications for patients.
    Darrow JJ; Avorn J; Kesselheim AS
    N Engl J Med; 2014 Jul; 371(1):89-90. PubMed ID: 24988576
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 11.