BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

228 related articles for article (PubMed ID: 29641963)

  • 1. 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]  

  • 2. The FDA Breakthrough-Drug Designation - Four Years of Experience.
    Darrow JJ; Avorn J; Kesselheim AS
    N Engl J Med; 2018 Apr; 378(15):1444-1453. PubMed ID: 29641970
    [No Abstract]   [Full Text] [Related]  

  • 3. 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]  

  • 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. Practical, legal, and ethical issues in expanded access to investigational drugs.
    Darrow JJ; Sarpatwari A; Avorn J; Kesselheim AS
    N Engl J Med; 2015 Jan; 372(3):279-86. PubMed ID: 25587952
    [No Abstract]   [Full Text] [Related]  

  • 6. 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]  

  • 7. TransMolecular receives FDA approval for 131-I-TM-601 IND application.
    Expert Rev Anticancer Ther; 2002 Apr; 2(2):139. PubMed ID: 12113233
    [No Abstract]   [Full Text] [Related]  

  • 8. FDA plans to continue cracking down on unapproved drugs.
    Lavine G
    Am J Health Syst Pharm; 2008 Sep; 65(17):1594. PubMed ID: 18714097
    [No Abstract]   [Full Text] [Related]  

  • 9. 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]  

  • 10. 2013 FDA drug approvals.
    Mullard A
    Nat Rev Drug Discov; 2014 Feb; 13(2):85-9. PubMed ID: 24481294
    [No Abstract]   [Full Text] [Related]  

  • 11. Risk versus risk: decision-making dilemmas of drug regulation in the United States and Germany.
    Daemmrich A; Krucken G
    Sci Cult (Lond); 2000 Dec; 9(4):505-34. PubMed ID: 15988846
    [No Abstract]   [Full Text] [Related]  

  • 12. The Food and Drug Administration's experimental drug approval system: is it good for your health?
    Myers BE
    Houst Law Rev; 1991 Jan; 28(1):309-36. PubMed ID: 12426696
    [No Abstract]   [Full Text] [Related]  

  • 13. 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]  

  • 14. 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]  

  • 15. 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]  

  • 16. 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]  

  • 17. 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]  

  • 18. 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]  

  • 19. The Federal Right to Try Act of 2017-A Wrong Turn for Access to Investigational Drugs and the Path Forward.
    Bateman-House A; Robertson CT
    JAMA Intern Med; 2018 Mar; 178(3):321-322. PubMed ID: 29356821
    [No Abstract]   [Full Text] [Related]  

  • 20. 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]  

    [Next]    [New Search]
    of 12.