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 *

146 related articles for article (PubMed ID: 34450093)

  • 21. Priority drugs well represented among 1998 approvals. FDA says all performance goals were met.
    Miller JL
    Am J Health Syst Pharm; 1999 Mar; 56(5):408, 411-2. PubMed ID: 10096697
    [No Abstract]   [Full Text] [Related]  

  • 22. "Fast tracking" drug approvals: is consumer safety being compromised?
    Jacobsen K
    QRC Advis; 2000 Jun; 16(8):5-9. PubMed ID: 10977137
    [No Abstract]   [Full Text] [Related]  

  • 23. Accelerating evidence gathering and approval of precision medicine therapies: the FDA takes aim at rare mutations.
    Issa AM; Thorogood A; Joly Y; Knoppers BM
    Genet Med; 2019 Mar; 21(3):542-544. PubMed ID: 29988078
    [No Abstract]   [Full Text] [Related]  

  • 24. Drug safety on trial.
    Nature; 2005 Mar; 434(7033):545. PubMed ID: 15800579
    [No Abstract]   [Full Text] [Related]  

  • 25. Pharmacogenomic data: FDA voluntary and required submission guidance.
    Salerno RA; Lesko LJ
    Pharmacogenomics; 2004 Jul; 5(5):503-5. PubMed ID: 15212586
    [No Abstract]   [Full Text] [Related]  

  • 26. US FDA feels the heat from Congressional hearings.
    Loewenberg S
    Lancet; 2008 May; 371(9624):1565-6. PubMed ID: 18476294
    [No Abstract]   [Full Text] [Related]  

  • 27. FDA drug-review, surveillance processes under scrutiny.
    Miller JL
    Am J Health Syst Pharm; 1999 Mar; 56(5):404, 406, 408. PubMed ID: 10096696
    [No Abstract]   [Full Text] [Related]  

  • 28. Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival: An Analysis of 5 Years of US Food and Drug Administration Approvals.
    Kim C; Prasad V
    JAMA Intern Med; 2015 Dec; 175(12):1992-4. PubMed ID: 26502403
    [No Abstract]   [Full Text] [Related]  

  • 29. Perspectives on the Current State of the Biosimilar Regulatory Pathway in the United States.
    Dougherty MK; Zineh I; Christl L
    Clin Pharmacol Ther; 2018 Jan; 103(1):36-38. PubMed ID: 29152721
    [TBL] [Abstract][Full Text] [Related]  

  • 30. Beyond fast track for drug approvals.
    Roberts TG; Chabner BA
    N Engl J Med; 2004 Jul; 351(5):501-5. PubMed ID: 15282359
    [No Abstract]   [Full Text] [Related]  

  • 31. FDA Breakthrough Therapy Designation: Evaluating the Quality of the Evidence behind the Drug Approvals.
    Herink MC; Irwin AN; Zumach GM
    Pharmacotherapy; 2018 Sep; 38(9):967-980. PubMed ID: 30043413
    [TBL] [Abstract][Full Text] [Related]  

  • 32. 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]  

  • 33. 2020 FDA drug approvals.
    Mullard A
    Nat Rev Drug Discov; 2021 Feb; 20(2):85-90. PubMed ID: 33402709
    [No Abstract]   [Full Text] [Related]  

  • 34. 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]  

  • 35. New drug and biological product approvals, 2010.
    Traynor K
    Am J Health Syst Pharm; 2011 Feb; 68(3):186, 188, 190. PubMed ID: 21258021
    [No Abstract]   [Full Text] [Related]  

  • 36. Drugs with FDA accelerated approval often have weak evidence, study finds.
    Dyer O
    BMJ; 2017 Jun; 357():j2905. PubMed ID: 28615167
    [No Abstract]   [Full Text] [Related]  

  • 37. 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]  

  • 38. Communicating with the FDA: the "third rail" of a new model for drug development.
    Stanski DR; Orloff JJ
    J Clin Pharmacol; 2008 Feb; 48(2):144-5. PubMed ID: 18199890
    [No Abstract]   [Full Text] [Related]  

  • 39. Regulatory watch: FDA new drug approvals in Q3 2018.
    Urquhart L
    Nat Rev Drug Discov; 2018 Oct; 17(11):779. PubMed ID: 30374181
    [No Abstract]   [Full Text] [Related]  

  • 40. Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond.
    Lemery S; Pazdur R
    Nat Rev Clin Oncol; 2022 Apr; 19(4):217-218. PubMed ID: 35136230
    [TBL] [Abstract][Full Text] [Related]  

    [Previous]   [Next]    [New Search]
    of 8.