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1991 1
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907 results

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Page 1
Implementation and Use of Risk Evaluation and Mitigation Strategies Programs in Practice: A Scoping Review of the Literature.
Tajchman S, Lawler B, Spence N, Haque S, Quintana Y, Ateya M. Tajchman S, et al. Appl Clin Inform. 2022 Oct;13(5):1151-1160. doi: 10.1055/s-0042-1758838. Epub 2022 Dec 8. Appl Clin Inform. 2022. PMID: 36482261 Free PMC article.
BACKGROUND: Risk Evaluation and Mitigation Strategy (REMS) programs intend to improve medication safety but can add significant administrative burdens to providers and health systems. ...Electronic health record interventions, such as customized …
BACKGROUND: Risk Evaluation and Mitigation Strategy (REMS) programs intend to improve medication safety b …
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. Boudes PF. Drugs R D. 2017 Jun;17(2):245-254. doi: 10.1007/s40268-017-0175-y. Drugs R D. 2017. PMID: 28160230 Free PMC article. Review.
Risk Evaluation and Mitigation Strategies (REMSs) with Elements to Assure Safe Use (ETASU) are requested for drugs with significant safety risks. ...In addition, REMSs are complex and their logic is inconsistent; we recommend a thorough re-ev
Risk Evaluation and Mitigation Strategies (REMSs) with Elements to Assure Safe Use (ETASU) are requested
Risk evaluation and mitigation strategies: a focus on the mycophenolic acid preparations.
Rostas S, Kim M, Gabardi S. Rostas S, et al. Prog Transplant. 2014 Mar;24(1):33-6. doi: 10.7182/pit2014521. Prog Transplant. 2014. PMID: 24598563 Review.
OBJECTIVE: To review risks associated with mycophenolic acid (MPA) preparations and evaluate their required risk evaluation and mitigation strategies (REMS) elements. DATA SOURCES AND EXTRACTION: Articles were identified through a non-date-limit …
OBJECTIVE: To review risks associated with mycophenolic acid (MPA) preparations and evaluate their required risk evaluation
How Do Risk Evaluation and Mitigation Strategies Impact Clinical Practice? A National Survey of Physicians.
Sarpatwari A, Lu Z, Russo M, Zakoul H, Lee SB, Toyserkani GA, Zhou EH, LaCivita C, Shaw KHH, Zendel L, Dal Pan GJ, Kesselheim AS. Sarpatwari A, et al. Clin Pharmacol Ther. 2024 Jun;115(6):1293-1303. doi: 10.1002/cpt.3189. Epub 2024 Feb 20. Clin Pharmacol Ther. 2024. PMID: 38375585
The US Food and Drug Administration can require risk evaluation and mitigation strategy (REMS) programs for prescription drugs to ensure the benefits of use outweigh the risks. ...Although 765 (68%) respondents thought the certification process …
The US Food and Drug Administration can require risk evaluation and mitigation strategy (REMS) programs f …
Heterocyclic amines in cooked meat products, shortcomings during evaluation, factors influencing formation, risk assessment and mitigation strategies.
Khan IA, Khan A, Zou Y, Zongshuai Z, Xu W, Wang D, Huang M. Khan IA, et al. Meat Sci. 2022 Feb;184:108693. doi: 10.1016/j.meatsci.2021.108693. Epub 2021 Oct 7. Meat Sci. 2022. PMID: 34775303 Review.
In addition, there is a lack of findings indicating a substantial correlation between various factors, like types of raw meat, types of meat products, and cooking methods that directly or indirectly influence the occurrence of cancer. Although numerous mitigation strate
In addition, there is a lack of findings indicating a substantial correlation between various factors, like types of raw meat, types of meat …
Mycophenolate fetal toxicity and risk evaluation and mitigation strategies.
Kim M, Rostas S, Gabardi S. Kim M, et al. Am J Transplant. 2013 Jun;13(6):1383-9. doi: 10.1111/ajt.12238. Epub 2013 Apr 25. Am J Transplant. 2013. PMID: 23617812 Free article. Review.
However, these agents carry a black box warning regarding their use during pregnancy due to an association with increased risk of miscarriage and congenital defects. To ensure that the benefits of MPA outweigh the risks, the Food and Drug Administration (FDA) required all …
However, these agents carry a black box warning regarding their use during pregnancy due to an association with increased risk of mis …
Risk evaluation and mitigation strategies for newly detected SARS-CoV-2 Omicron BF.7 subvariant: A brief report.
Nazmunnahar, Ahmed I, Islam MR. Nazmunnahar, et al. Health Sci Rep. 2023 Mar 2;6(3):e1127. doi: 10.1002/hsr2.1127. eCollection 2023 Mar. Health Sci Rep. 2023. PMID: 36875932 Free PMC article.
Here we aimed to evaluate the potential risks of this newly detected variant and identify possible mitigation strategies. The frequent mutation associated with SARS-CoV-2 makes it more concerning compared to other viruses. ...
Here we aimed to evaluate the potential risks of this newly detected variant and identify possible mitigation strategies. The …
Risk evaluation and mitigation strategies (REMS): educating the prescriber.
Nicholson SC, Peterson J, Yektashenas B. Nicholson SC, et al. Drug Saf. 2012 Feb 1;35(2):91-104. doi: 10.2165/11597840-000000000-00000. Drug Saf. 2012. PMID: 22171604 Review.
A provision of this law granted the FDA new powers to enhance drug safety by requiring the pharmaceutical industry to develop Risk Evaluation and Mitigation Strategies (REMS). REMS are deemed necessary when a question exists as to whether the be …
A provision of this law granted the FDA new powers to enhance drug safety by requiring the pharmaceutical industry to develop Risk
907 results