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 *

143 related articles for article (PubMed ID: 39183127)

  • 1. 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]  

  • 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. 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]  

  • 4. Regulatory Review Duration and Differences in Submission Times of Drugs in the United States and Europe, 2011 to 2020.
    Vokinger KN; Serra-Burriel M; Glaus CEG; Rohr UP; Hwang TJ; Dalla Torre di Sanguinetto S; Kesselheim AS
    Ann Intern Med; 2023 Oct; 176(10):1413-1418. PubMed ID: 37844306
    [TBL] [Abstract][Full Text] [Related]  

  • 5. 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]  

  • 6. Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019.
    Lythgoe MP; Desai A; Gyawali B; Savage P; Krell J; Warner JL; Khaki AR
    JAMA Netw Open; 2022 Jun; 5(6):e2216183. PubMed ID: 35687337
    [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. Cancer drug indication approvals in China and the United States: a comparison of approval times and clinical benefit, 2001-2020.
    Wei Y; Zhang Y; Xu Z; Wang G; Zhou Y; Li H; Shi L; Naci H; Wagner AK; Guan X
    Lancet Reg Health West Pac; 2024 Apr; 45():101055. PubMed ID: 38590780
    [TBL] [Abstract][Full Text] [Related]  

  • 9. 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]  

  • 10. The impact of FDA and EMA regulatory decision-making process on the access to CFTR modulators for the treatment of cystic fibrosis.
    Costa E; Girotti S; Pauro F; Leufkens HGM; Cipolli M
    Orphanet J Rare Dis; 2022 May; 17(1):188. PubMed ID: 35525974
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Approval probabilities and regulatory review patterns for anticancer drugs in the European Union.
    Hartmann M; Mayer-Nicolai C; Pfaff O
    Crit Rev Oncol Hematol; 2013 Aug; 87(2):112-21. PubMed ID: 23433721
    [TBL] [Abstract][Full Text] [Related]  

  • 12. To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016.
    Kühler TC; Bujar M; McAuslane N; Liberti L
    BMJ Open; 2019 Nov; 9(11):e028677. PubMed ID: 31772082
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Antibodies to watch in 2017.
    Reichert JM
    MAbs; 2017; 9(2):167-181. PubMed ID: 27960628
    [TBL] [Abstract][Full Text] [Related]  

  • 14. 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]  

  • 15. 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]  

  • 16. Post-marketing surveillance framework of cell and gene therapy products in the European Union, the United States, Japan, South Korea and China: a comparative study.
    Cai Y; Sui L; Wang J; Qian W; Peng Y; Gong L; Wu W; Gao Y
    BMC Med; 2024 Sep; 22(1):421. PubMed ID: 39334246
    [TBL] [Abstract][Full Text] [Related]  

  • 17. 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]  

  • 18. 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]  

  • 19. 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]  

  • 20. Continued cancer drug approvals in Japan and Europe after market withdrawal in the United States: A comparative study of accelerated approvals.
    Hakariya H; Moriarty F; Ozaki A; Mulinari S; Saito H; Tanimoto T
    Clin Transl Sci; 2024 Jul; 17(7):e13879. PubMed ID: 38987923
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 8.