691 related articles for article (PubMed ID: 23244814)
1. Comparisons of Food and Drug Administration and European Medicines Agency risk management implementation for recent pharmaceutical approvals: report of the International Society for Pharmacoeconomics and outcomes research risk benefit management working group.
Lis Y; Roberts MH; Kamble S; J Guo J; Raisch DW
Value Health; 2012 Dec; 15(8):1108-18. PubMed ID: 23244814
[TBL] [Abstract][Full Text] [Related]
2. Risk evaluation and mitigation strategies: impact on patients, health care providers, and health systems.
Shane R
Am J Health Syst Pharm; 2009 Dec; 66(24 Suppl 7):S6-S12. PubMed ID: 19966079
[TBL] [Abstract][Full Text] [Related]
3. Examination of risk evaluation and mitigation strategies and drug safety in the US.
Rodriguez-Monguio R; Spielberger K; Seoane-Vazquez E
Res Social Adm Pharm; 2014; 10(1):232-8. PubMed ID: 23611865
[TBL] [Abstract][Full Text] [Related]
4. Pharmaceutical industry perspective on risk evaluation and mitigation strategies: manufacturer take heed.
Nicholson S; Peterson J; Yektashenas B
Expert Opin Drug Saf; 2012 Mar; 11(2):299-314. PubMed ID: 22233294
[TBL] [Abstract][Full Text] [Related]
5. Understanding risk evaluation and mitigation strategies in organ transplantation.
Gabardi S
Pharmacotherapy; 2011 Jul; 31(7):714-22. PubMed ID: 21923459
[TBL] [Abstract][Full Text] [Related]
6. FDA's risk evaluation and mitigation strategies (REMS): effective and efficient safety tools or process poltergeist?
Wilson A; Milne CP
Food Drug Law J; 2011; 66(4):569-85, ii. PubMed ID: 24505829
[TBL] [Abstract][Full Text] [Related]
7. The US Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) Program - Current Status and Future Direction.
Wu J; Juhaeri J
Clin Ther; 2016 Dec; 38(12):2526-2532. PubMed ID: 27914632
[TBL] [Abstract][Full Text] [Related]
8. Risk evaluation and mitigation strategies (REMS): educating the prescriber.
Nicholson SC; Peterson J; Yektashenas B
Drug Saf; 2012 Feb; 35(2):91-104. PubMed ID: 22171604
[TBL] [Abstract][Full Text] [Related]
9. The Food and Drug Administration Amendments Act of 2007: drug safety and health-system pharmacy implications.
Meyer BM
Am J Health Syst Pharm; 2009 Dec; 66(24 Suppl 7):S3-5. PubMed ID: 19966078
[TBL] [Abstract][Full Text] [Related]
10. Adaptation for Regulatory Application: A Content Analysis of FDA Risk Evaluation and Mitigation Strategies Assessment Plans (2014-2018) Using RE-AIM.
Toyserkani GA; Huynh L; Morrato EH
Front Public Health; 2020; 8():43. PubMed ID: 32158741
[No Abstract] [Full Text] [Related]
11. Managing the Risks of Medicines: An Examination of FDA's Application of Criteria for Requiring a REMS.
Seligman PJ; Anguiano RH; Felix T; Stabi K
Ther Innov Regul Sci; 2019 Jul; 53(4):542-548. PubMed ID: 30226799
[TBL] [Abstract][Full Text] [Related]
12. The FDA and drug safety: a proposal for sweeping changes.
Furberg CD; Levin AA; Gross PA; Shapiro RS; Strom BL
Arch Intern Med; 2006 Oct; 166(18):1938-42. PubMed ID: 17030825
[TBL] [Abstract][Full Text] [Related]
13. Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: A Retrospective Cohort Study.
Botelho SF; Martins MA; Vieira LB; Reis AM
J Clin Pharmacol; 2017 Apr; 57(4):493-499. PubMed ID: 27568487
[TBL] [Abstract][Full Text] [Related]
14. Evolution of opioid risk management and review of the classwide REMS for extended-release/long-acting opioids.
Stanos S
Phys Sportsmed; 2012 Nov; 40(4):12-20. PubMed ID: 23306411
[TBL] [Abstract][Full Text] [Related]
15. 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]
16. Anatomy of Risk Evaluation and Mitigation Strategies (REMS).
Loeser KK; McKoy JM; Schumock GT
Cancer Treat Res; 2019; 171():93-105. PubMed ID: 30552659
[TBL] [Abstract][Full Text] [Related]
17. APhA 2011 REMS white paper: Summary of the REMS stakeholder meeting on improving program design and implementation.
American Pharmacists Association ; Bough M
J Am Pharm Assoc (2003); 2011; 51(3):340-58. PubMed ID: 21555285
[TBL] [Abstract][Full Text] [Related]
18. A guide to understanding and implementing risk evaluation and mitigation strategies in organ transplantation.
Gabardi S; Tichy EM
Prog Transplant; 2013 Mar; 23(1):58-62; quiz 63. PubMed ID: 23448822
[TBL] [Abstract][Full Text] [Related]
19. Risk evaluation mitigation strategies: the evolution of risk management policy.
Hollingsworth K; Toscani M
Popul Health Manag; 2013 Apr; 16(2):132-7. PubMed ID: 23113627
[TBL] [Abstract][Full Text] [Related]
20. Pharmaceutical risk management in Turkey: the first national overview.
Aydinkarahaliloglu ND; Aykac E; Kasap Y; Durmus N; Babacanoglu C; Basgut CE; Artiran G; Kerman S
Regul Toxicol Pharmacol; 2013 Dec; 67(3):344-50. PubMed ID: 23994623
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]