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 *

158 related articles for article (PubMed ID: 34370737)

  • 21. A European initiative to unclog pipeline for new medicines.
    Macleod M; Steckler T
    Nature; 2019 Apr; 568(7753):458. PubMed ID: 31015692
    [No Abstract]   [Full Text] [Related]  

  • 22. [Harmonisation of the Marketing Authorisation Application dossier: perspectives due to harmonised requirements. Assessing Rules and the Common Technical Document].
    Menges K
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2008 Jul; 51(7):748-56. PubMed ID: 18584104
    [TBL] [Abstract][Full Text] [Related]  

  • 23. Changing standards for drug approval: A longitudinal analysis of conditional marketing authorisation in the European Union.
    Hoekman J; Boon W
    Soc Sci Med; 2019 Feb; 222():76-83. PubMed ID: 30605802
    [TBL] [Abstract][Full Text] [Related]  

  • 24. Clinical trial designs to obtain marketing authorization of drugs for haematological malignancy in Japan, the EU and the US.
    Nagai S; Ozawa K
    Br J Haematol; 2016 Jul; 174(2):249-54. PubMed ID: 27018163
    [TBL] [Abstract][Full Text] [Related]  

  • 25. 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]  

  • 26. [Adaptive authorization: a new way for the early access of new drugs?].
    Dal-Ré R; Carné X
    Med Clin (Barc); 2015 Mar; 144(6):275-8. PubMed ID: 25312485
    [No Abstract]   [Full Text] [Related]  

  • 27. Granting marketing authorisation for medicines in South East European countries: the point of view of the authority.
    Tomić S; Sucić AF; Martinac AI
    Regul Toxicol Pharmacol; 2010; 57(2-3):325-32. PubMed ID: 20385190
    [TBL] [Abstract][Full Text] [Related]  

  • 28. [How does a new medicine reach the patient?].
    Visser BJ; Korevaar DA; Mokhles MM; Vermeer-Pragt W; de Boer A; Giezen TJ
    Ned Tijdschr Geneeskd; 2020 Jul; 164():. PubMed ID: 32779914
    [TBL] [Abstract][Full Text] [Related]  

  • 29. Non-clinical Post-Marketing Commitments for newly licenced pharmaceuticals.
    Reeve LM
    Regul Toxicol Pharmacol; 2009 Nov; 55(2):181-7. PubMed ID: 19589365
    [TBL] [Abstract][Full Text] [Related]  

  • 30. Guidelines on similar biologics: regulatory requirements for marketing authorization in India.
    Rathore A
    PDA J Pharm Sci Technol; 2012; 66(5):393. PubMed ID: 23035022
    [No Abstract]   [Full Text] [Related]  

  • 31. New antirheumatic drugs: any real added value? A critical overview of regulatory criteria for their marketing approval.
    Bertele' V; Assisi A; Di Muzio V; Renzo D; Garattini S
    Eur J Clin Pharmacol; 2007 Sep; 63(9):879-89. PubMed ID: 17646975
    [TBL] [Abstract][Full Text] [Related]  

  • 32. A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines.
    Garsen M; Steenhof M; Zwiers A
    Ther Innov Regul Sci; 2021 Jul; 55(4):633-642. PubMed ID: 33543409
    [TBL] [Abstract][Full Text] [Related]  

  • 33. Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.
    Arnardottir AH; Haaijer-Ruskamp FM; Straus SM; de Graeff PA; Mol PG
    Drug Saf; 2011 Nov; 34(11):1101-14. PubMed ID: 21981437
    [TBL] [Abstract][Full Text] [Related]  

  • 34. Data and market exclusivity for pharmaceuticals in the European Community.
    Kingham RF; Castle GH
    Food Drug Law J; 2000; 55(2):209-23. PubMed ID: 12269365
    [No Abstract]   [Full Text] [Related]  

  • 35. Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.
    Jokura Y; Yano K; Yamato M
    J Tissue Eng Regen Med; 2018 Feb; 12(2):e1056-e1062. PubMed ID: 28211195
    [TBL] [Abstract][Full Text] [Related]  

  • 36. New European commission regulation on variations to the terms of marketing authorization for medicinal products and its impact on Croatian legislation.
    Martinac AI; Tomić S; Simicić M
    Arh Hig Rada Toksikol; 2010 Sep; 61(3):311-22. PubMed ID: 20860972
    [TBL] [Abstract][Full Text] [Related]  

  • 37. [Application for marketing authorization accepted for the the treatment of adult diabetes].
    Solignac M
    Soins; 2013 Jun; (776):8. PubMed ID: 23878876
    [No Abstract]   [Full Text] [Related]  

  • 38. European Medicines Agency Perspective on Oncology Study Design for Marketing Authorization and Beyond.
    Jonsson B; Martinalbo J; Pignatti F
    Clin Pharmacol Ther; 2017 May; 101(5):577-579. PubMed ID: 28073148
    [TBL] [Abstract][Full Text] [Related]  

  • 39. Navigating Market Authorization: The Path Holoclar Took to Become the First Stem Cell Product Approved in the European Union.
    Pellegrini G; Ardigò D; Milazzo G; Iotti G; Guatelli P; Pelosi D; De Luca M
    Stem Cells Transl Med; 2018 Jan; 7(1):146-154. PubMed ID: 29280318
    [TBL] [Abstract][Full Text] [Related]  

  • 40. A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.
    Coppens DGM; de Wilde S; Guchelaar HJ; De Bruin ML; Leufkens HGM; Meij P; Hoekman J
    Cytotherapy; 2018 Jun; 20(6):769-778. PubMed ID: 29730080
    [TBL] [Abstract][Full Text] [Related]  

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