353 related articles for article (PubMed ID: 33926608)
1. EMA and FDA psychiatric drug trial guidelines: assessment of guideline development and trial design recommendations.
Boesen K; Gøtzsche PC; Ioannidis JPA
Epidemiol Psychiatr Sci; 2021 Apr; 30():e35. PubMed ID: 33926608
[TBL] [Abstract][Full Text] [Related]
2. Requesting conflicts of interest declarations from the European Medicines Agency: 3-year follow-up status.
Boesen K; Gøtzsche PC; Ioannidis JPA
Epidemiol Psychiatr Sci; 2024 Mar; 33():e17. PubMed ID: 38529624
[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. Comparison of the EMA and FDA Guidelines on Ulcerative Colitis Drug Development.
Reinisch W; Gottlieb K; Colombel JF; Danese S; Panaccione R; Panes J; Peyrin-Biroulet L; Rubin D; Sands BE; Schreiber S; Vermeire S; Mulberg A; Sandborn B
Clin Gastroenterol Hepatol; 2019 Aug; 17(9):1673-1679.e1. PubMed ID: 31352970
[TBL] [Abstract][Full Text] [Related]
5. 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]
6. 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]
7. 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]
8. Out of balance: conflicts of interest persist in food chemicals determined to be generally recognized as safe.
Matouskova K; Neltner TG; Maffini MV
Environ Health; 2023 Sep; 22(1):59. PubMed ID: 37670318
[TBL] [Abstract][Full Text] [Related]
9. The future of Cochrane Neonatal.
Soll RF; Ovelman C; McGuire W
Early Hum Dev; 2020 Nov; 150():105191. PubMed ID: 33036834
[TBL] [Abstract][Full Text] [Related]
10. Evaluation of designs for renal drug studies based on the European Medicines Agency and Food and Drug Administration guidelines for drugs that are predominantly secreted.
Pradhan S; Wright DFB; Duffull SB
Br J Clin Pharmacol; 2021 Mar; 87(3):1401-1410. PubMed ID: 32857419
[TBL] [Abstract][Full Text] [Related]
11. 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]
12. 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]
13. Accessibility of clinical study reports supporting medicine approvals: a cross-sectional evaluation.
Hopkins AM; Modi ND; Rockhold FW; Hoffmann T; Menz BD; Veroniki AA; McKinnon RA; Rowland A; Swain SM; Ross JS; Sorich MJ
J Clin Epidemiol; 2024 Mar; 167():111263. PubMed ID: 38219810
[TBL] [Abstract][Full Text] [Related]
14. The draft FDA guideline on non-inferiority clinical trials: a critical review from European pharmaceutical industry statisticians.
Huitfeldt B; Hummel J;
Pharm Stat; 2011; 10(5):414-9. PubMed ID: 21932294
[TBL] [Abstract][Full Text] [Related]
15. Conflicts of interest in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews: associations with recommendations.
Nejstgaard CH; Bero L; Hróbjartsson A; Jørgensen AW; Jørgensen KJ; Le M; Lundh A
Cochrane Database Syst Rev; 2020 Dec; 12(12):MR000040. PubMed ID: 33289919
[TBL] [Abstract][Full Text] [Related]
16. Comparison of published core outcome sets with outcomes recommended in regulatory guidance from the US Food and Drug Administration and European Medicines Agency: cross sectional analysis.
Saldanha IJ; Dodd S; Fish R; Gorst SL; Hall DA; Jacobsen P; Kirkham JJ; Trepel D; Williamson PR
BMJ Med; 2022; 1(1):e000233. PubMed ID: 36936602
[TBL] [Abstract][Full Text] [Related]
17. Procedures and methods of benefit assessments for medicines in Germany.
Bekkering GE; Kleijnen J
Eur J Health Econ; 2008 Nov; 9 Suppl 1():5-29. PubMed ID: 18987905
[TBL] [Abstract][Full Text] [Related]
18. Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015.
Zhang AD; Schwartz JL; Ross JS
Milbank Q; 2019 Sep; 97(3):796-819. PubMed ID: 31304643
[TBL] [Abstract][Full Text] [Related]
19. Process of drug registration in Israel: the correlation between the number of discussions within the Ministry of Health and postapproval variations by EMA and/or FDA.
Hiayev S; Shacham-Shmueli E; Berkovitch M; Weiss I; Ashkenazi S; Vexberg MH; Hershkowitz R; Gorelik E; Mayan H; Steinmetz Y; Yanai NB; Schlissel O; Azem M; Gutgold N; Shulman K; Divinsky M; Yarom N; Vishkautzan A; Ganzel C; Gatt ME; Arcavi L; Marom E; Uziely B; Zevin S; Meirow H; Luxenburg O; Ainbinder D
BMJ Open; 2023 May; 13(5):e067313. PubMed ID: 37142315
[TBL] [Abstract][Full Text] [Related]
20. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.
Downing NS; Aminawung JA; Shah ND; Krumholz HM; Ross JS
JAMA; 2014 Jan 22-29; 311(4):368-77. PubMed ID: 24449315
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]