362 related articles for article (PubMed ID: 33838392)
1. 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]
2. Re: Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years: French temporary authorisation for use (ATU) and early access to therapeutic innovations: there are still many patients slipping through the cracks.
Bayle A; Hollebecque A; Pistilli B; Massard C; Marabelle A
Eur J Cancer; 2021 Oct; 156():217-221. PubMed ID: 34400059
[No 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. Temporary authorization for use: does the French patient access programme for unlicensed medicines impact market access after formal licensing?
Degrassat-Théas A; Paubel P; Parent de Curzon O; Le Pen C; Sinègre M
Pharmacoeconomics; 2013 Apr; 31(4):335-43. PubMed ID: 23529210
[TBL] [Abstract][Full Text] [Related]
5. [Administrative delays of temporary recommendation for use: Impact on access to innovation in melanoma].
Auger C; Guillot B; Monard A; Albin N
Bull Cancer; 2022 Jan; 109(1):28-37. PubMed ID: 34972538
[TBL] [Abstract][Full Text] [Related]
6. 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]
7. 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]
8. Monitoring evidence on overall survival benefits of anticancer drugs approved by the European Medicines Agency between 2009 and 2015.
Grössmann N; Robausch M; Rosian K; Wild C; Simon J
Eur J Cancer; 2019 Mar; 110():1-7. PubMed ID: 30735832
[TBL] [Abstract][Full Text] [Related]
9. 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]
10. 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]
11. A Qualitative Study on the Differences Between Trial Populations and the Approved Therapeutic Indications of Antineoplastic Agents by 3 Regulatory Agencies From 2010 to 2018.
Sumi E; Asada R; Lu Y; Ito-Ihara T; Grimes KV
Clin Ther; 2020 Feb; 42(2):305-320.e0. PubMed ID: 32008723
[TBL] [Abstract][Full Text] [Related]
12. Assessment of Food and Drug Administration- and European Medicines Agency-Approved Systemic Oncology Therapies and Clinically Meaningful Improvements in Quality of Life: A Systematic Review.
Arciero V; Delos Santos S; Koshy L; Rahmadian A; Saluja R; Everest L; Parmar A; Chan KKW
JAMA Netw Open; 2021 Feb; 4(2):e2033004. PubMed ID: 33570573
[TBL] [Abstract][Full Text] [Related]
13. Comparing patient access to pharmaceuticals in the UK and US.
Cohen J; Cairns C; Paquette C; Faden L
Appl Health Econ Health Policy; 2006; 5(3):177-87. PubMed ID: 17132032
[TBL] [Abstract][Full Text] [Related]
14. Availability of Investigational Medicines Through the US Food and Drug Administration's Expanded Access and Compassionate Use Programs.
Puthumana J; Miller JE; Kim J; Ross JS
JAMA Netw Open; 2018 Jun; 1(2):e180283. PubMed ID: 30646072
[TBL] [Abstract][Full Text] [Related]
15. 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]
16. 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]
17. 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]
18. 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]
19. 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]
20. 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]
[Next] [New Search]