151 related articles for article (PubMed ID: 35877034)
1. A Comparison of Safety Information in Drug Labeling at the Initial Approval of New Drugs Approved Both in Japan and the United States.
Hoshino Y; Narukawa M
Ther Innov Regul Sci; 2022 Sep; 56(5):839-847. PubMed ID: 35877034
[TBL] [Abstract][Full Text] [Related]
2. A comparison of decision and timing of safety related labeling changes for new drugs approved both in Japan and the United States.
Hoshino Y; Narukawa M
Pharmacoepidemiol Drug Saf; 2021 May; 30(5):561-572. PubMed ID: 33559352
[TBL] [Abstract][Full Text] [Related]
3. Decision and timing of safety-related labeling changes for new drugs in Japan: Comparison with the United States and the European Union.
Fukuda K; Narukawa M
Pharmacoepidemiol Drug Saf; 2023 Dec; 32(12):1331-1340. PubMed ID: 37395168
[TBL] [Abstract][Full Text] [Related]
4. Review of FDA Amendments Act Section 921 Experience in Posting Data-mining Results from the FAERS Database.
Beninger P; Murray M
Clin Ther; 2021 Feb; 43(2):380-395. PubMed ID: 33504449
[TBL] [Abstract][Full Text] [Related]
5. Safety information in drug labeling: a comparison of the USA, the UK, and Japan.
Shimazawa R; Ikeda M
Pharmacoepidemiol Drug Saf; 2013 Mar; 22(3):306-18. PubMed ID: 23355452
[TBL] [Abstract][Full Text] [Related]
6. Differences between the United States and Japan in labels of oncological drugs.
Jayaputra K; Ono S
Pharmacoepidemiol Drug Saf; 2017 Feb; 26(2):143-151. PubMed ID: 27670850
[TBL] [Abstract][Full Text] [Related]
7. Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.
Schick A; Miller KL; Lanthier M; Dal Pan G; Nardinelli C
Drug Saf; 2017 Jun; 40(6):497-503. PubMed ID: 28342075
[TBL] [Abstract][Full Text] [Related]
8. Differences in pharmacogenomic biomarker information in package inserts from the United States, the United Kingdom and Japan.
Shimazawa R; Ikeda M
J Clin Pharm Ther; 2013 Dec; 38(6):468-75. PubMed ID: 23895776
[TBL] [Abstract][Full Text] [Related]
9. Sources of Evidence Triggering and Supporting Safety-Related Labeling Changes: A 10-Year Longitudinal Assessment of 22 New Molecular Entities Approved in 2008 by the US Food and Drug Administration.
Croteau D; Pinnow E; Wu E; Muñoz M; Bulatao I; Dal Pan G
Drug Saf; 2022 Feb; 45(2):169-180. PubMed ID: 35113347
[TBL] [Abstract][Full Text] [Related]
10. Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals.
Frank C; Himmelstein DU; Woolhandler S; Bor DH; Wolfe SM; Heymann O; Zallman L; Lasser KE
Health Aff (Millwood); 2014 Aug; 33(8):1453-9. PubMed ID: 25092848
[TBL] [Abstract][Full Text] [Related]
11. Timing of new black box warnings and withdrawals for prescription medications.
Lasser KE; Allen PD; Woolhandler SJ; Himmelstein DU; Wolfe SM; Bor DH
JAMA; 2002 May; 287(17):2215-20. PubMed ID: 11980521
[TBL] [Abstract][Full Text] [Related]
12. Postmarket safety communications on drugs approved in Japan: A 25-year analysis.
Tanaka Y; Tanaka M; Miyazawa H; Terashima R; Miyazawa M; Ikuma M; Tomita Y
Clin Transl Sci; 2024 Apr; 17(4):e13803. PubMed ID: 38651283
[TBL] [Abstract][Full Text] [Related]
13. Ethical and Practical Considerations in Removing Black Box Warnings from Drug Labels.
Yeh JS; Sarpatwari A; Kesselheim AS
Drug Saf; 2016 Aug; 39(8):709-14. PubMed ID: 27000800
[TBL] [Abstract][Full Text] [Related]
14. An Audit of Black Box Warnings (BBWs) in the United States Food and Drug Administration (US-FDA) Database - A Five-Year Analysis.
Bose D; Gogtay N; Goel T; Konwar M
Curr Drug Saf; 2022; 17(1):54-58. PubMed ID: 34382527
[TBL] [Abstract][Full Text] [Related]
15. New and incremental FDA black box warnings from 2008 to 2015.
Solotke MT; Dhruva SS; Downing NS; Shah ND; Ross JS
Expert Opin Drug Saf; 2018 Feb; 17(2):117-123. PubMed ID: 29215916
[TBL] [Abstract][Full Text] [Related]
16. [Association between Post-marketing Safety-related Regulatory Actions and Characteristics of New Drugs Approved in Japan between 2005 and 2016].
Watanabe Y; Narukawa M
Yakugaku Zasshi; 2022; 142(7):761-770. PubMed ID: 35781506
[TBL] [Abstract][Full Text] [Related]
17. Risk management policy and black-box warnings: a qualitative analysis of US FDA proceedings.
Cook DM; Gurugubelli RK; Bero LA
Drug Saf; 2009; 32(11):1057-66. PubMed ID: 19810777
[TBL] [Abstract][Full Text] [Related]
18. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.
Downing NS; Shah ND; Aminawung JA; Pease AM; Zeitoun JD; Krumholz HM; Ross JS
JAMA; 2017 May; 317(18):1854-1863. PubMed ID: 28492899
[TBL] [Abstract][Full Text] [Related]
19. Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs.
Kim J; Nair A; Keegan P; Beaver JA; Kluetz PG; Pazdur R; Chuk M; Blumenthal GM
Oncologist; 2020 Apr; 25(4):348-354. PubMed ID: 32297444
[TBL] [Abstract][Full Text] [Related]
20. Analysis of factors related to the occurrence of important drug-specific postmarketing safety-related regulatory actions: A cohort study focused on first-in-class drugs.
Ikeda J; Kaneko M; Narukawa M
Pharmacoepidemiol Drug Saf; 2018 Dec; 27(12):1393-1401. PubMed ID: 30094880
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]