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.
196 related articles for article (PubMed ID: 39195315)
1. New Oncologic Drugs from 2008 to 2023-Differences in Approval and Access between the United States, Europe and Brazil. Barreto RB; Izidoro AM; Miranda MHF Curr Oncol; 2024 Aug; 31(8):4443-4454. PubMed ID: 39195315 [TBL] [Abstract][Full Text] [Related]
2. 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]
3. 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]
4. 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]
5. A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs. Zeukeng MJ; Seoane-Vazquez E; Bonnabry P Eur J Clin Pharmacol; 2018 Jun; 74(6):811-818. PubMed ID: 29470610 [TBL] [Abstract][Full Text] [Related]
6. A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016). Gnanasakthy A; Barrett A; Evans E; D'Alessio D; Romano CD Value Health; 2019 Feb; 22(2):203-209. PubMed ID: 30711065 [TBL] [Abstract][Full Text] [Related]
7. Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals? Alqahtani S; Seoane-Vazquez E; Rodriguez-Monguio R; Eguale T Pharmacoepidemiol Drug Saf; 2015 Jul; 24(7):709-15. PubMed ID: 26013294 [TBL] [Abstract][Full Text] [Related]
8. Canadian, European and United States new drug approval times now relatively similar. Rawson NSB Regul Toxicol Pharmacol; 2018 Jul; 96():121-126. PubMed ID: 29730446 [TBL] [Abstract][Full Text] [Related]
9. Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval. Joppi R; Bertele V; Vannini T; Garattini S; Banzi R Br J Clin Pharmacol; 2020 Jan; 86(1):170-174. PubMed ID: 31657044 [TBL] [Abstract][Full Text] [Related]
10. 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]
11. 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]
12. [Comparative assessment of off-label and unlicensed drug prescription in neonatal intensive care: FDA versus Brazilian guidelines]. Costa HTML; Florencio AP; Bezerra PKDV; Cavalcanti JEC; Costa TX; Fernandes FEM; Martins RR An Pediatr (Engl Ed); 2021 Mar; 94(3):153-160. PubMed ID: 33514478 [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. Rationales of delay and difference in regulatory review by Japan, the USA and Europe among new drugs first approved in Japan. Tanaka M; Idei M; Sakaguchi H; Kato R; Sato D; Sawanobori K; Kawarasaki S; Hata T; Yoshizaki A; Nakamura M; Ikuma M Br J Clin Pharmacol; 2021 Aug; 87(8):3279-3291. PubMed ID: 33511674 [TBL] [Abstract][Full Text] [Related]
15. Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years. Jacquet E; Kerouani-Lafaye G; Grude F; Goncalves S; Lorence A; Turcry F; Brunel L; Belgodere L; Monard A; Guyader G; Boudali L; Albin N Eur J Cancer; 2021 May; 149():82-90. PubMed ID: 33838392 [TBL] [Abstract][Full Text] [Related]
16. FDA and EMA Approvals of New Breast Cancer Drugs-A Comparative Regulatory Analysis. Leo CP; Hentschel B; Szucs TD; Leo C Cancers (Basel); 2020 Feb; 12(2):. PubMed ID: 32069837 [TBL] [Abstract][Full Text] [Related]
17. Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia. Hwang TJ; Kesselheim AS; Tibau A; Lee CC; Vokinger KN JCO Oncol Pract; 2022 Sep; 18(9):e1522-e1532. PubMed ID: 35731996 [TBL] [Abstract][Full Text] [Related]
18. Clinical benefit, reimbursement outcomes, and prices of FDA-approved cancer drugs reviewed through Project Orbis in the USA, Canada, England, and Scotland: a retrospective, comparative analysis. Jenei K; Gentilini A; Haslam A; Prasad V Lancet Oncol; 2024 Aug; 25(8):979-988. PubMed ID: 39004098 [TBL] [Abstract][Full Text] [Related]
19. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999-2014. Hatswell AJ; Baio G; Berlin JA; Irs A; Freemantle N BMJ Open; 2016 Jun; 6(6):e011666. PubMed ID: 27363818 [TBL] [Abstract][Full Text] [Related]
20. 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] [Next] [New Search]