824 related articles for article (PubMed ID: 27363818)
1. 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]
2. Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: a systematic review.
Goring S; Taylor A; Müller K; Li TJJ; Korol EE; Levy AR; Freemantle N
BMJ Open; 2019 Feb; 9(2):e024895. PubMed ID: 30819708
[TBL] [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. 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]
5. 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]
6. 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]
7. A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014-2016: Concordance, Discordance, and Why.
Kashoki M; Hanaizi Z; Yordanova S; Veselý R; Bouygues C; Llinares J; Kweder SL
Clin Pharmacol Ther; 2020 Jan; 107(1):195-202. PubMed ID: 31306483
[TBL] [Abstract][Full Text] [Related]
8. 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]
9. 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]
10. 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]
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. 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]
13. Assessment of PRO label claims granted by the FDA as compared to the EMA (2006-2010).
DeMuro C; Clark M; Doward L; Evans E; Mordin M; Gnanasakthy A
Value Health; 2013 Dec; 16(8):1150-5. PubMed ID: 24326168
[TBL] [Abstract][Full Text] [Related]
14. Larger effect sizes in nonrandomized studies are associated with higher rates of EMA licensing approval.
Djulbegovic B; Glasziou P; Klocksieben FA; Reljic T; VanDenBergh M; Mhaskar R; Ioannidis JPA; Chalmers I
J Clin Epidemiol; 2018 Jun; 98():24-32. PubMed ID: 29432860
[TBL] [Abstract][Full Text] [Related]
15. Immune checkpoint inhibitors for the treatment of non-small cell lung cancer: A comparison of the regulatory approvals in Europe and the United States.
Zaim R; Redekop K; Uyl-de Groot CA
J Cancer Policy; 2022 Sep; 33():100346. PubMed ID: 35779788
[TBL] [Abstract][Full Text] [Related]
16. U.S. Food and Drug Administration anticancer drug approval trends from 2016 to 2018 for lung, colorectal, breast, and prostate cancer.
Ribeiro TB; Ribeiro A; Rodrigues LO; Harada G; Nobre MRC
Int J Technol Assess Health Care; 2020; 36(1):20-28. PubMed ID: 31775939
[TBL] [Abstract][Full Text] [Related]
17. 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]
18. Strength of clinical evidence leading to approval of novel cancer medicines in Europe: A systematic review and data synthesis.
Farina A; Moro F; Fasslrinner F; Sedghi A; Bromley M; Siepmann T
Pharmacol Res Perspect; 2021 Aug; 9(4):e00816. PubMed ID: 34232554
[TBL] [Abstract][Full Text] [Related]
19. Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study.
Hwang TJ; Ross JS; Vokinger KN; Kesselheim AS
BMJ; 2020 Oct; 371():m3434. PubMed ID: 33028575
[TBL] [Abstract][Full Text] [Related]
20. 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]
[Next] [New Search]