354 related articles for article (PubMed ID: 32158741)
1. 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]
2. Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014-2018).
Huynh L; Toyserkani GA; Morrato EH
BMC Health Serv Res; 2021 Aug; 21(1):779. PubMed ID: 34362367
[TBL] [Abstract][Full Text] [Related]
3. 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]
4. Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU).
Boudes PF
Drugs R D; 2017 Jun; 17(2):245-254. PubMed ID: 28160230
[TBL] [Abstract][Full Text] [Related]
5. 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]
6. 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]
7. 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]
8. 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]
9. Patient and Caregiver Experiences With and Perceptions of Risk Evaluation and Mitigation Strategy Programs With Elements to Assure Safe Use.
Sarpatwari A; Brown BL; McGraw SA; Dejene SZ; Abdurrob A; Santiago Ortiz AJ; Kesselheim AS
JAMA Netw Open; 2022 Jan; 5(1):e2144386. PubMed ID: 35050352
[TBL] [Abstract][Full Text] [Related]
10. 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]
11. 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]
12. 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]
13. 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]
14. What is the quality of drug safety information for patients: An analysis of REMS educational materials.
Chan HW; Russell AM; Smith MY
Pharmacoepidemiol Drug Saf; 2018 Sep; 27(9):969-978. PubMed ID: 30003610
[TBL] [Abstract][Full Text] [Related]
15. Physician experiences with and perceptions of risk evaluation and mitigation strategy programs with elements to assure safe use.
Sarpatwari A; Brown BL; McGraw SA; Dejene SZ; Abdurrob A; Kesselheim AS
PLoS One; 2023; 18(7):e0288008. PubMed ID: 37410756
[TBL] [Abstract][Full Text] [Related]
16. A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs.
Sarpatwari A; Mitra-Majumdar M; Bykov K; Avorn J; Woloshin S; Toyserkani GA; LaCivita C; Manzo C; Zhou EH; Pinnow E; Dal Pan GJ; Gagne JJ; Huybrechts KF; Feldman WB; Chin K; Kesselheim AS
Drug Saf; 2021 Jul; 44(7):743-751. PubMed ID: 33904111
[TBL] [Abstract][Full Text] [Related]
17. Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007-2020).
Toyserkani GA; Ewusie SB; Turk P; Quick J; Morrato EH
Drug Saf; 2023 Nov; 46(11):1073-1087. PubMed ID: 37697204
[TBL] [Abstract][Full Text] [Related]
18. Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration: A Review.
Heyward J; Olson L; Sharfstein JM; Stuart EA; Lurie P; Alexander GC
JAMA Intern Med; 2020 Feb; 180(2):301-309. PubMed ID: 31886822
[TBL] [Abstract][Full Text] [Related]
19. Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use.
Marquez L; Raheja R; Chan-Liston M; Marcinak J; Estilo A; Pineda Salgado L; Jiang J; Chang C; Beninger P
Drug Saf; 2024 Jan; 47(1):1-22. PubMed ID: 37874451
[TBL] [Abstract][Full Text] [Related]
20. 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]
[Next] [New Search]