162 related articles for article (PubMed ID: 31846100)
1. Post-marketing safety-related regulatory actions on first-in-class drugs: A double-cohort study.
Ikeda J; Kaneko M; Narukawa M
J Clin Pharm Ther; 2020 Jun; 45(3):496-502. PubMed ID: 31846100
[TBL] [Abstract][Full Text] [Related]
2. 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]
3. [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]
4. Safety-related regulatory actions for biologicals approved in the United States and the European Union.
Giezen TJ; Mantel-Teeuwisse AK; Straus SM; Schellekens H; Leufkens HG; Egberts AC
JAMA; 2008 Oct; 300(16):1887-96. PubMed ID: 18940975
[TBL] [Abstract][Full Text] [Related]
5. Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.
Arnardottir AH; Haaijer-Ruskamp FM; Straus SM; de Graeff PA; Mol PG
Drug Saf; 2011 Nov; 34(11):1101-14. PubMed ID: 21981437
[TBL] [Abstract][Full Text] [Related]
6. 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]
7. Safety-related regulatory actions for orphan drugs in the US and EU: a cohort study.
Heemstra HE; Giezen TJ; Mantel-Teeuwisse AK; de Vrueh RL; Leufkens HG
Drug Saf; 2010 Feb; 33(2):127-37. PubMed ID: 20082539
[TBL] [Abstract][Full Text] [Related]
8. 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]
9. 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]
10. 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]
11. Postmarketing safety of orphan drugs: a longitudinal analysis of the US Food and Drug Administration database between 1999 and 2018.
Fan M; Chan AYL; Yan VKC; Tong X; Lau LKW; Wan EYF; Tam EYT; Ip P; Lum TY; Wong ICK; Li X
Orphanet J Rare Dis; 2022 Jan; 17(1):3. PubMed ID: 34983612
[TBL] [Abstract][Full Text] [Related]
12. Post-approval safety issues with innovative drugs: a European cohort study.
Mol PG; Arnardottir AH; Motola D; Vrijlandt PJ; Duijnhoven RG; Haaijer-Ruskamp FM; de Graeff PA; Denig P; Straus SM
Drug Saf; 2013 Nov; 36(11):1105-15. PubMed ID: 24048690
[TBL] [Abstract][Full Text] [Related]
13. Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014.
Pinnow E; Amr S; Bentzen SM; Brajovic S; Hungerford L; St George DM; Dal Pan G
Clin Pharmacol Ther; 2018 Aug; 104(2):390-400. PubMed ID: 29266187
[TBL] [Abstract][Full Text] [Related]
14. Postmarketing Safety-Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002-2014: Similarities and Differences With New Molecular Entities.
Bulatao I; Pinnow E; Day B; Cherkaoui S; Kalaria M; Brajovic S; Dal Pan G
Clin Pharmacol Ther; 2020 Dec; 108(6):1243-1253. PubMed ID: 32557564
[TBL] [Abstract][Full Text] [Related]
15. Twenty Years of Targeted and Biologic Immunomodulatory Drugs: Postmarketing Modifications of Drug Labels Approved by the US Food and Drug Administration.
Berman J; Yavne Y; Edel Y; Elkayam O; Furer V; Shepshelovich D
Mayo Clin Proc; 2022 Aug; 97(8):1512-1522. PubMed ID: 35933136
[TBL] [Abstract][Full Text] [Related]
16. Assessment of the impact of scheduled postmarketing safety summary analyses on regulatory actions.
Sekine S; Pinnow EE; Wu E; Kurtzig R; Hall M; Dal Pan GJ
Clin Pharmacol Ther; 2016 Jul; 100(1):102-8. PubMed ID: 26853718
[TBL] [Abstract][Full Text] [Related]
17. Consistency in the safety labeling of bioequivalent medications.
Duke J; Friedlin J; Li X
Pharmacoepidemiol Drug Saf; 2013 Mar; 22(3):294-301. PubMed ID: 23042584
[TBL] [Abstract][Full Text] [Related]
18. Postmarketing Safety-Related Modifications of Drugs Approved by the US Food and Drug Administration Between 1999 and 2014 Without Randomized Controlled Trials.
Shepshelovich D; Tibau A; Goldvaser H; Ocana A; Seruga B; Amir E
Mayo Clin Proc; 2019 Jan; 94(1):74-83. PubMed ID: 30611457
[TBL] [Abstract][Full Text] [Related]
19. A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports.
Hoffman KB; Dimbil M; Tatonetti NP; Kyle RF
Drug Saf; 2016 Jun; 39(6):561-75. PubMed ID: 26946292
[TBL] [Abstract][Full Text] [Related]
20. Safety of Biologics Approved for the Treatment of Rheumatoid Arthritis and Other Autoimmune Diseases: A Disproportionality Analysis from the FDA Adverse Event Reporting System (FAERS).
Araujo AGS; Borba HHL; Tonin FS; Lenzi L; Venson R; Pontarolo R; Wiens A
BioDrugs; 2018 Aug; 32(4):377-390. PubMed ID: 29873000
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
