154 related articles for article (PubMed ID: 38488755)
1. Synthetic Approaches to the New Drugs Approved During 2022.
France SP; Lindsey EA; McInturff EL; Berritt S; Carney DW; DeForest JC; Fink SJ; Flick AC; Gibson TS; Gray K; Johnson AM; Leverett CA; Liu Y; Mahapatra S; Watson RB
J Med Chem; 2024 Mar; 67(6):4376-4418. PubMed ID: 38488755
[TBL] [Abstract][Full Text] [Related]
2. 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]
3. 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]
4. Assessment of the Delay in Novel Anticancer Drugs between China and the United States: A Comparative Study of Drugs Approved between 2010 and 2021.
Luo X; Du X; Li Z; Qian F; Yang Y
Clin Pharmacol Ther; 2023 Jan; 113(1):170-181. PubMed ID: 36151921
[TBL] [Abstract][Full Text] [Related]
5. Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions.
Bennett CL; Schoen MW; Hoque S; Witherspoon BJ; Aboulafia DM; Hwang CS; Ray P; Yarnold PR; Chen BK; Schooley B; Taylor MA; Wyatt MD; Hrushesky WJ; Yang YT
Lancet Oncol; 2020 Dec; 21(12):e575-e588. PubMed ID: 33271114
[TBL] [Abstract][Full Text] [Related]
6. Assessing drug lag in new drug approvals by the Iran Food and Drug Administration compared to the U.S. FDA, EMA, and PMDA: A 20-year analysis (2001-2021).
Alipour S; Nadimi Parashkouhi S; Mojahedian M; Abbasian H
Medicine (Baltimore); 2024 Jun; 103(25):e38142. PubMed ID: 38905367
[TBL] [Abstract][Full Text] [Related]
7. 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]
8. Small molecule anticancer drugs approved during 2021-2022: Synthesis and clinical applications.
Tamatam R; Mohammed A
Eur J Med Chem; 2024 Jun; 272():116441. PubMed ID: 38759455
[TBL] [Abstract][Full Text] [Related]
9. 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]
10. 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]
11. New drug approvals for 2021: Synthesis and clinical applications.
Yuan S; Wang DS; Liu H; Zhang SN; Yang WG; Lv M; Zhou YX; Zhang SY; Song J; Liu HM
Eur J Med Chem; 2023 Jan; 245(Pt 1):114898. PubMed ID: 36370552
[TBL] [Abstract][Full Text] [Related]
12. Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.
Gupta R; Bollyky TJ; Cohen M; Ross JS; Kesselheim AS
BMJ; 2018 Mar; 360():k831. PubMed ID: 29555641
[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. Synthesis and clinical application of new drugs approved by FDA in 2023.
Wang YT; Yang PC; Zhang YF; Sun JF
Eur J Med Chem; 2024 Feb; 265():116124. PubMed ID: 38183778
[TBL] [Abstract][Full Text] [Related]
15. 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]
16. Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan.
Oye KA; Eichler HG; Hoos A; Mori Y; Mullin TM; Pearson M
Clin Pharmacol Ther; 2016 Dec; 100(6):626-632. PubMed ID: 27618128
[TBL] [Abstract][Full Text] [Related]
17. Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU.
Demirci E; Omes-Smit G; Zwiers A
Clin Transl Sci; 2023 Jul; 16(7):1127-1133. PubMed ID: 37013379
[TBL] [Abstract][Full Text] [Related]
18. 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]
19. 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]
20. 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]
[Next] [New Search]
