BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

184 related articles for article (PubMed ID: 38200263)

  • 1. Analysis and comparative evaluation of expedited programs for gene therapy products: insights from the United States, the European Union, Japan, and South Korea.
    Jeong H; Purja S; Kim E
    Gene Ther; 2024 May; 31(5-6):242-254. PubMed ID: 38200263
    [TBL] [Abstract][Full Text] [Related]  

  • 2. 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]  

  • 3. 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]  

  • 4. 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]  

  • 5. [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]  

  • 6. An overview of cancer drugs approved through expedited approval programs and orphan medicine designation globally between 2011 and 2020.
    Wang S; Yang Q; Deng L; Lei Q; Yang Y; Ma P; Men Y; Yung BC; Lee RJ; Zhang M; Li N
    Drug Discov Today; 2022 May; 27(5):1236-1250. PubMed ID: 34971818
    [TBL] [Abstract][Full Text] [Related]  

  • 7. A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the US and EU.
    da Costa Gonçalves F; Demirci E; Zwiers A
    Clin Transl Sci; 2022 Aug; 15(8):1959-1967. PubMed ID: 35561071
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Regenerative medicine regulatory policies: A systematic review and international comparison.
    Qiu T; Hanna E; Dabbous M; Borislav B; Toumi M
    Health Policy; 2020 Jul; 124(7):701-713. PubMed ID: 32499078
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU.
    Demirci E; Omes-Smit G; Zwiers A
    Clin Transl Sci; 2023 Jul; 16(7):1127-1133. PubMed ID: 37013379
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Regulatory Aspects for Approval of Advanced Therapy Medicinal Products in the EU.
    Fürst-Ladani S; Bührer A; Fürst W; Schober-Ladani N
    Handb Exp Pharmacol; 2024; 284():367-387. PubMed ID: 37017789
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021.
    Monge AN; Sigelman DW; Temple RJ; Chahal HS
    JAMA Netw Open; 2022 Nov; 5(11):e2239336. PubMed ID: 36318210
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies.
    Roberts SW; Elvang TLB; Syed L; Samuelsen MB; Arp-Hansen EL; Nielsen HK; Lund IK; Dünweber DL; Listov-Saabye N; Bjørn-Larsen D; Hjelmsmark A; Mikkelsen TA
    Ther Innov Regul Sci; 2023 Mar; 57(2):386-395. PubMed ID: 36401076
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Impact of expedited programs in the United States, as foreign regulatory factors, on clinical development time in Japan.
    Tajima G; Matsumaru N; Tsukamoto K
    J Clin Pharm Ther; 2022 Sep; 47(9):1395-1401. PubMed ID: 35488803
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan.
    Halioua-Haubold CL; Peyer JG; Smith JA; Arshad Z; Scholz M; Brindley DA; MacLaren RE
    Yale J Biol Med; 2017 Dec; 90(4):683-693. PubMed ID: 29259533
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Matched analysis on orphan drug designations and approvals: cross regional analysis in the United States, the European Union, and Japan.
    Murakami M; Narukawa M
    Drug Discov Today; 2016 Apr; 21(4):544-9. PubMed ID: 26945941
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Analysis of GMP for marketing authorization of ATMPs: comparison in the US, the EU, Japan and South Korea.
    Shin H; Kim E
    Regen Med; 2022 May; 17(5):283-297. PubMed ID: 35232285
    [No Abstract]   [Full Text] [Related]  

  • 17. 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]  

  • 18. The association between US Food and Drug Administration-expedited review designations and health plan specialty drug coverage.
    Panzer AD; Ingham M; Martin S; Chambers JD
    J Manag Care Spec Pharm; 2023 May; 29(5):464-471. PubMed ID: 36989444
    [No Abstract]   [Full Text] [Related]  

  • 19. Influence of Expedited Programs in the United States on Oncology Drug Development in Japan.
    Tanaka M; Matsumaru N; Tsukamoto K
    Ther Innov Regul Sci; 2019 Mar; 53(2):199-206. PubMed ID: 29732928
    [TBL] [Abstract][Full Text] [Related]  

  • 20. A Drug Discovery Perspective on FDA Expedited Development and Incentive Programs.
    Brown DG
    J Med Chem; 2024 Feb; 67(3):1690-1700. PubMed ID: 38233132
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 10.