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 *

188 related articles for article (PubMed ID: 38341388)

  • 21. 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]  

  • 22. Real-world Data and Evidence to support a switch in status from Prescription drug to Over the Counter drug as applied by the EMA, the US FDA, the MHRA, and the BfArM.
    Kühler TC; Ateka A; Lassoued Z; Routhier FX; Mékary-Sawaya S
    Clin Ther; 2024 Mar; 46(3):208-216. PubMed ID: 38278703
    [TBL] [Abstract][Full Text] [Related]  

  • 23. 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]  

  • 24. A Comparative Review of Marketing Authorization Decisions in Switzerland, the EU, and the USA.
    Dalla Torre Di Sanguinetto S; Heinonen E; Antonov J; Bolte C
    Ther Innov Regul Sci; 2019 Jan; 53(1):86-94. PubMed ID: 29714594
    [TBL] [Abstract][Full Text] [Related]  

  • 25. Development and regulation of biosimilars: current status and future challenges.
    Tsiftsoglou AS; Ruiz S; Schneider CK
    BioDrugs; 2013 Jun; 27(3):203-11. PubMed ID: 23553340
    [TBL] [Abstract][Full Text] [Related]  

  • 26. Use of Real-world Data for New Drug Applications and Line Extensions.
    Bolislis WR; Fay M; Kühler TC
    Clin Ther; 2020 May; 42(5):926-938. PubMed ID: 32340916
    [TBL] [Abstract][Full Text] [Related]  

  • 27. A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors.
    Shah RR; Roberts SA; Shah DR
    Br J Clin Pharmacol; 2013 Sep; 76(3):396-411. PubMed ID: 23362829
    [TBL] [Abstract][Full Text] [Related]  

  • 28. The use of real-world data/evidence in regulatory submissions.
    Song F; Zang C; Ma X; Hu S; Sun Q; Chow SC; Sun H
    Contemp Clin Trials; 2021 Oct; 109():106521. PubMed ID: 34339865
    [TBL] [Abstract][Full Text] [Related]  

  • 29. The EMA Review of Mylotarg (Gemtuzumab Ozogamicin) for the Treatment of Acute Myeloid Leukemia.
    Ali S; Dunmore HM; Karres D; Hay JL; Salmonsson T; Gisselbrecht C; Sarac SB; Bjerrum OW; Hovgaard D; Barbachano Y; Nagercoil N; Pignatti F
    Oncologist; 2019 May; 24(5):e171-e179. PubMed ID: 30898889
    [TBL] [Abstract][Full Text] [Related]  

  • 30. 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]  

  • 31. The role of Real-World Data and evidence in oncology medicines approved in EU in 2018-2019.
    Eskola SM; Leufkens HGM; Bate A; De Bruin ML; Gardarsdottir H
    J Cancer Policy; 2023 Jun; 36():100424. PubMed ID: 37116794
    [TBL] [Abstract][Full Text] [Related]  

  • 32. Real-World Evidence to Support EU Regulatory Decision Making-Results From a Pilot of Regulatory Use Cases.
    Prilla S; Groeneveld S; Pacurariu A; Restrepo-Méndez MC; Verpillat P; Torre C; Gartner C; Mol PGM; Naumann-Winter F; Breen KC; Gault N; Gross-Martirosyan L; Benchetrit S; Aylward B; Stoyanova-Beninska V; O'Donovan M; Straus S; Kjaer J; Arlett P
    Clin Pharmacol Ther; 2024 Nov; 116(5):1188-1197. PubMed ID: 38962830
    [TBL] [Abstract][Full Text] [Related]  

  • 33. Trabectedin: Ecteinascidin 743, Ecteinascidin-743, ET 743, ET-743, NSC 684766.
    Drugs R D; 2006; 7(5):317-28. PubMed ID: 16922593
    [TBL] [Abstract][Full Text] [Related]  

  • 34. Use of Real-World Evidence in Neuroscience-Related New Drug and Biologics License Applications for Novel Therapeutics.
    Bloomfield-Clagett B; Rahman M; Smith K; Concato J
    Clin Pharmacol Ther; 2023 Nov; 114(5):1002-1005. PubMed ID: 37548904
    [TBL] [Abstract][Full Text] [Related]  

  • 35. The Role of Real-World Evidence in FDA-Approved New Drug and Biologics License Applications.
    Purpura CA; Garry EM; Honig N; Case A; Rassen JA
    Clin Pharmacol Ther; 2022 Jan; 111(1):135-144. PubMed ID: 34726771
    [TBL] [Abstract][Full Text] [Related]  

  • 36. 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]  

  • 37. Romosozumab: First Global Approval.
    Markham A
    Drugs; 2019 Mar; 79(4):471-476. PubMed ID: 30805895
    [TBL] [Abstract][Full Text] [Related]  

  • 38. [Scientific advice by the nationally competent authority and by the EMEA on the conduct of clinical trials].
    Dejas-Eckertz P; Schäffner G
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Apr; 48(4):423-8. PubMed ID: 15830253
    [TBL] [Abstract][Full Text] [Related]  

  • 39. Real-World Evidence Utilization in Clinical Development Reflected by US Product Labeling: Statistical Review.
    Seifu Y; Gamalo-Siebers M; Barthel FM; Lin J; Qiu J; Cooner F; Ruan S; Walley R
    Ther Innov Regul Sci; 2020 Nov; 54(6):1436-1443. PubMed ID: 32514737
    [TBL] [Abstract][Full Text] [Related]  

  • 40. The New FDA Real-World Evidence Program to Support Development of Drugs and Biologics.
    Klonoff DC
    J Diabetes Sci Technol; 2020 Mar; 14(2):345-349. PubMed ID: 30862182
    [TBL] [Abstract][Full Text] [Related]  

    [Previous]   [Next]    [New Search]
    of 10.