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 *

164 related articles for article (PubMed ID: 36388912)

  • 1. Mandatory requirements for pediatric drug development in the EU and the US for novel drugs-A comparative study.
    Christiansen H; De Bruin ML; Hallgreen CE
    Front Med (Lausanne); 2022; 9():1009432. PubMed ID: 36388912
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations.
    Ghadanian M; Schafheutle E
    Ther Innov Regul Sci; 2024 Jan; 58(1):79-113. PubMed ID: 37861859
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
    Salcher-Konrad M; Naci H; Davis C
    Milbank Q; 2020 Dec; 98(4):1219-1256. PubMed ID: 33021339
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021.
    Vokinger KN; Kesselheim AS; Glaus CEG; Hwang TJ
    JAMA Health Forum; 2022 Aug; 3(8):e222685. PubMed ID: 36200635
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Enabling Development of Paediatric Medicines in Europe: 10 Years of the EU Paediatric Regulation.
    Tomasi PA; Egger GF; Pallidis C; Saint-Raymond A
    Paediatr Drugs; 2017 Dec; 19(6):505-513. PubMed ID: 28900869
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Comparing supplemental indications for cancer drugs approved in the US and EU.
    Stoelinga J; Bloem LT; Russo M; Kesselheim AS; Feldman WB
    Eur J Cancer; 2024 Nov; 212():114330. PubMed ID: 39368223
    [TBL] [Abstract][Full Text] [Related]  

  • 7. [Pediatric drug development: ICH harmonized tripartite guideline E11 within the United States of America, the European Union, and Japan].
    Pflieger M; Bertram D
    Arch Pediatr; 2014 Oct; 21(10):1129-38. PubMed ID: 25175054
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval.
    Cherla A; Naci H; Kesselheim AS; Gyawali B; Mossialos E
    JAMA Intern Med; 2021 Apr; 181(4):490-498. PubMed ID: 33616607
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States.
    Penkov D; Tomasi P; Eichler I; Murphy D; Yao LP; Temeck J
    Ther Innov Regul Sci; 2017 May; 51(3):360-371. PubMed ID: 28674673
    [TBL] [Abstract][Full Text] [Related]  

  • 10. A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013.
    Egger GF; Wharton GT; Malli S; Temeck J; Murphy MD; Tomasi P
    Ther Innov Regul Sci; 2016 Sep; 50(5):639-647. PubMed ID: 27274951
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US.
    Christiansen H; De Bruin ML; Frokjaer S; Hallgreen CE
    PLoS One; 2022; 17(4):e0266353. PubMed ID: 35377911
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States.
    Iglesias-Lopez C; Obach M; Vallano A; Agustí A
    Cytotherapy; 2021 Mar; 23(3):261-274. PubMed ID: 33483292
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Initial and supplementary indication approval of new targeted cancer drugs by the FDA, EMA, Health Canada, and TGA.
    Michaeli DT; Mills M; Michaeli T; Miracolo A; Kanavos P
    Invest New Drugs; 2022 Aug; 40(4):798-809. PubMed ID: 35389145
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen.
    Giannuzzi V; Conte R; Landi A; Ottomano SA; Bonifazi D; Baiardi P; Bonifazi F; Ceci A
    Orphanet J Rare Dis; 2017 Apr; 12(1):64. PubMed ID: 28372595
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Comparison of novel oncology drugs that received dual approval from the US accelerated approval and EU conditional marketing authorisation pathways, 2006-2021: a cross-sectional study.
    Xie J; Li J; Liu Y; Wang H; Wang Y; Yang Y; Chen Y; Jiang R; Shao R
    BMJ Open; 2023 Jun; 13(6):e069132. PubMed ID: 37286329
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Application of orphan drug designation to cancer treatments (2008-2017): a comprehensive and comparative analysis of the USA and EU.
    Vokinger KN; Kesselheim AS
    BMJ Open; 2019 Oct; 9(10):e028634. PubMed ID: 31601584
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Clinical development and marketing application review times for novel orphan-designated drugs.
    Demirci E; Knicley J; Fiorentino L
    Front Med (Lausanne); 2024; 11():1404922. PubMed ID: 38903827
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Withdrawn accelerated approvals for cancer indications in the USA: what is the marketing authorisation status in the EU?
    Cramer A; Sørup FKH; Christensen HR; Petersen TS; Karstoft K
    Lancet Oncol; 2023 Sep; 24(9):e385-e394. PubMed ID: 37657479
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Differential times of submission and approval of CFTR modulators for the treatment of Cystic Fibrosis in the United States and the European Union.
    Costa E; Girotti S; Mathieu C; Castellani C; Ross JS; Taylor-Cousar JL; Leufkens HGM
    J Cyst Fibros; 2024 Aug; ():. PubMed ID: 39183127
    [TBL] [Abstract][Full Text] [Related]  

  • 20. European Union pediatric legislation jeopardizes worldwide, timely future advances in the care of children with cancer.
    Rose K
    Clin Ther; 2014 Feb; 36(2):163-77. PubMed ID: 24529288
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 9.