250 related articles for article (PubMed ID: 27803605)
1. Cross-comparison of cancer drug approvals at three international regulatory agencies.
Samuel N; Verma S
Curr Oncol; 2016 Oct; 23(5):e454-e460. PubMed ID: 27803605
[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. 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]
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. 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]
6. 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]
7. 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]
8. 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]
9. 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]
10. 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]
11. Comparison of Drug Approvals in Europe Versus the United States: An Analysis of Discrepancies Between Drug Products Reviewed by EMA and FDA.
Makuch RW; Shi R
Ther Innov Regul Sci; 2014 May; 48(3):362-366. PubMed ID: 30235531
[TBL] [Abstract][Full Text] [Related]
12. 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]
13. 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]
14. Regulatory review of novel therapeutics--comparison of three regulatory agencies.
Downing NS; Aminawung JA; Shah ND; Braunstein JB; Krumholz HM; Ross JS
N Engl J Med; 2012 Jun; 366(24):2284-93. PubMed ID: 22591257
[TBL] [Abstract][Full Text] [Related]
15. A comparative study of cancer drug approvals in india and high-income countries.
Roy AM; Jones R; Mathew A
J Cancer Policy; 2022 Sep; 33():100349. PubMed ID: 35902067
[TBL] [Abstract][Full Text] [Related]
16. Health Canada Usage of Real World Evidence (RWE) in Regulatory Decision Making compared with FDA/EMA usage based on publicly available information.
Lau C; Jamali F; Loebenberg R
J Pharm Pharm Sci; 2022; 25():227-236. PubMed ID: 35760071
[TBL] [Abstract][Full Text] [Related]
17. Similarities and differences in the oncology drug approval process between FDA and European Union with emphasis on in vitro companion diagnostics.
Senderowicz AM; Pfaff O
Clin Cancer Res; 2014 Mar; 20(6):1445-52. PubMed ID: 24634467
[TBL] [Abstract][Full Text] [Related]
18. 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]
19. 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]
20. Comparison of oncology drug approval between Health Canada and the US Food and Drug Administration.
Ezeife DA; Truong TH; Heng DY; Bourque S; Welch SA; Tang PA
Cancer; 2015 May; 121(10):1688-93. PubMed ID: 25604014
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
