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 *

174 related articles for article (PubMed ID: 29732928)

  • 61. Patient-Centered Cancer Drug Development: Clinical Trials, Regulatory Approval, and Value Assessment.
    Gyawali B; Hwang TJ; Vokinger KN; Booth CM; Amir E; Tibau A
    Am Soc Clin Oncol Educ Book; 2019 Jan; 39():374-387. PubMed ID: 31099613
    [TBL] [Abstract][Full Text] [Related]  

  • 62. Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study.
    Mostaghim SR; Gagne JJ; Kesselheim AS
    BMJ; 2017 Sep; 358():j3837. PubMed ID: 28882831
    [No Abstract]   [Full Text] [Related]  

  • 63. 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]  

  • 64. FDA's Expedited Programs and Their Impact on the Availability of New Therapies.
    Damle N; Shah S; Nagraj P; Tabrizi P; Rodriguez GE; Bhambri R
    Ther Innov Regul Sci; 2017 Jan; 51(1):24-28. PubMed ID: 30235999
    [TBL] [Abstract][Full Text] [Related]  

  • 65. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.
    DiMasi JA
    Clin Ther; 2013 Jun; 35(6):808-18. PubMed ID: 23726388
    [TBL] [Abstract][Full Text] [Related]  

  • 66. 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]  

  • 67. 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]  

  • 68. 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]  

  • 69. [Pharmaceutical approval process of drugs for hematological malignancies: current situations in Japan].
    Nagai S
    Rinsho Ketsueki; 2020; 61(5):437-444. PubMed ID: 32507805
    [TBL] [Abstract][Full Text] [Related]  

  • 70. FDA and EMA Approvals of New Breast Cancer Drugs-A Comparative Regulatory Analysis.
    Leo CP; Hentschel B; Szucs TD; Leo C
    Cancers (Basel); 2020 Feb; 12(2):. PubMed ID: 32069837
    [TBL] [Abstract][Full Text] [Related]  

  • 71. Accelerated approval of oncology products: a decade of experience.
    Dagher R; Johnson J; Williams G; Keegan P; Pazdur R
    J Natl Cancer Inst; 2004 Oct; 96(20):1500-9. PubMed ID: 15494600
    [TBL] [Abstract][Full Text] [Related]  

  • 72. Critical review of 'Public domain application': a flexible drug approval system in Japan.
    Ito Y; Narimatsu H; Fukui T; Fukao A; Yoshioka T
    Ann Oncol; 2013 May; 24(5):1297-305. PubMed ID: 23532113
    [TBL] [Abstract][Full Text] [Related]  

  • 73. Exploratory Analysis of Drug Lag in New Oncology Drugs Between Japan and the US.
    Maki A; Narukawa M
    Ther Innov Regul Sci; 2023 Jul; 57(4):671-677. PubMed ID: 36966205
    [TBL] [Abstract][Full Text] [Related]  

  • 74. Regulatory approval pathways for anticancer drugs in Japan, the EU and the US.
    Nagai S; Ozawa K
    Int J Hematol; 2016 Jul; 104(1):73-84. PubMed ID: 27084259
    [TBL] [Abstract][Full Text] [Related]  

  • 75. Maximizing Regulatory Review Efficiency: The Evolution of the FDA OCE RTOR Pilot.
    Gao YG; Roberts S; Guy A
    Ther Innov Regul Sci; 2022 Mar; 56(2):212-219. PubMed ID: 35006588
    [TBL] [Abstract][Full Text] [Related]  

  • 76. International oncology drug approvals for multiregional or single-country clinical trials: A systematic review.
    Zhang M; Onakpoya I; Rupalla K
    Front Med (Lausanne); 2022; 9():1084980. PubMed ID: 36590932
    [TBL] [Abstract][Full Text] [Related]  

  • 77. Exploratory Analysis of Associations Between Postmarketing Safety Events and Approved Doses of New Drugs in Japan.
    Okubo TK; Ono S
    Clin Transl Sci; 2017 Jul; 10(4):280-286. PubMed ID: 28371388
    [TBL] [Abstract][Full Text] [Related]  

  • 78. Ethical imperatives of timely access to orphan drugs: is possible to reconcile economic incentives and patients' health needs?
    Rodriguez-Monguio R; Spargo T; Seoane-Vazquez E
    Orphanet J Rare Dis; 2017 Jan; 12(1):1. PubMed ID: 28057032
    [TBL] [Abstract][Full Text] [Related]  

  • 79. The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative.
    Jarow JP; Casak S; Chuk M; Ehrlich LA; Khozin S
    Clin Cancer Res; 2016 May; 22(9):2111-3. PubMed ID: 26783289
    [TBL] [Abstract][Full Text] [Related]  

  • 80. Japanese regulatory system for approval of off-label drug use: evaluation of safety and effectiveness in literature-based applications.
    Shimazawa R; Ikeda M
    Clin Ther; 2012 Oct; 34(10):2104-16. PubMed ID: 23036337
    [TBL] [Abstract][Full Text] [Related]  

    [Previous]   [Next]    [New Search]
    of 9.