268 related articles for article (PubMed ID: 20947724)
1. NCCN Oncology Risk Evaluation and Mitigation Strategies White Paper: Recommendations for Stakeholders.
Johnson PE; Dahlman G; Eng K; Garg R; Gottlieb S; Hoffman JM; Howell P; Jahanzeb M; Johnson S; Mackler E; Rubino M; Sarokhan B; Marc Stewart F; Tyler T; Vose JM; Weinstein S; Li EC; Demartino J;
J Natl Compr Canc Netw; 2010 Sep; 8 Suppl 7():S7-S27. PubMed ID: 20947724
[TBL] [Abstract][Full Text] [Related]
2. 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]
3. 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]
4. 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]
5. 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]
6. 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]
7. 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]
8. White paper on designing a risk evaluation and mitigation strategies (REMS) system to optimize the balance of patient access, medication safety, and impact on the health care system.
American Pharmacists Association
J Am Pharm Assoc (2003); 2009; 49(6):729-43. PubMed ID: 19926553
[TBL] [Abstract][Full Text] [Related]
9. 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]
10. Assessment of risk evaluation and mitigation strategies in oncology: summary of the oncology risk evaluation and mitigation strategies workshop.
Frame JN; Jacobson JO; Vogel WH; Griffith N; Wariabharaj D; Garg R; Zon R; Stephens CL; Bialecki AM; Bruinooge SS; Allen SL
J Oncol Pract; 2013 Mar; 9(2):e24-39. PubMed ID: 23814522
[TBL] [Abstract][Full Text] [Related]
11. NCCN Biosimilars White Paper: regulatory, scientific, and patient safety perspectives.
Zelenetz AD; Ahmed I; Braud EL; Cross JD; Davenport-Ennis N; Dickinson BD; Goldberg SE; Gottlieb S; Johnson PE; Lyman GH; Markus R; Matulonis UA; Reinke D; Li EC; DeMartino J; Larsen JK; Hoffman JM
J Natl Compr Canc Netw; 2011 Sep; 9 Suppl 4():S1-22. PubMed ID: 21976013
[TBL] [Abstract][Full Text] [Related]
12. The process of NCCN guidelines adaptation to the Middle East and North Africa region.
Jazieh AR; Azim HA; McClure J; Jahanzeb M
J Natl Compr Canc Netw; 2010 Jul; 8 Suppl 3():S5-7. PubMed ID: 20697132
[TBL] [Abstract][Full Text] [Related]
13. 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]
14. 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]
15. Mitigating the safety risks of drugs with a focus on opioids: are risk evaluation and mitigation strategies the answer?
Brooks MJ
Mayo Clin Proc; 2014 Dec; 89(12):1673-84. PubMed ID: 25441401
[TBL] [Abstract][Full Text] [Related]
16. Off-label use of medical products in radiation therapy: summary of the report of AAPM Task Group No. 121.
Thomadsen BR; Heaton HT; Jani SK; Masten JP; Napolitano ME; Ouhib Z; Reft CS; Rivard MJ; Robin TT; Subramanian M; Suleiman OH
Med Phys; 2010 May; 37(5):2300-11. PubMed ID: 20527564
[TBL] [Abstract][Full Text] [Related]
17. 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]
18. 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]
19. 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]
20. Risk evaluation and mitigation strategies: assessment of a medical center's policies and procedures.
Childs L; Alexander E; Duong MT
Am J Health Syst Pharm; 2012 May; 69(10):885-9. PubMed ID: 22555085
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]