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   Articles with "evaluation mitigation" as a keyword



Isotretinoin Risk Evaluation and Mitigation Strategy and Pregnancy Incidence.

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recommendations! Published in 2025 at "JAMA internal medicine"

DOI: 10.1001/jamainternmed.2025.3168

Abstract: This cohort study examines pregnancy incidence among publicly and commercially insured female patients using isotretinoin vs topical retinoids, stratified by patient characteristics. read more here.

Keywords: isotretinoin risk; evaluation mitigation; risk evaluation; pregnancy ... See more keywords

Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing

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recommendations! Published in 2019 at "JAMA Network Open"

DOI: 10.1001/jamanetworkopen.2019.1340

Abstract: Key Points Question Was the implementation of the Transmucosal Immediate-Release Fentanyl (TIRF)–Risk Evaluation and Mitigation Strategy (REMS) associated with changes in prescribing of TIRF medications? Findings In this cohort study using interrupted times series analysis,… read more here.

Keywords: evaluation mitigation; transmucosal; risk evaluation; mitigation strategy ... See more keywords

Implementation and Use of Risk Evaluation and Mitigation Strategies Programs in Practice: A Scoping Review of the Literature

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recommendations! Published in 2022 at "Applied Clinical Informatics"

DOI: 10.1055/s-0042-1758838

Abstract: Abstract Background  Risk Evaluation and Mitigation Strategy (REMS) programs intend to improve medication safety but can add significant administrative burdens to providers and health systems. Various stakeholders have made efforts to use technology to improve… read more here.

Keywords: risk evaluation; review; rems programs; scoping review ... See more keywords

Abstract 4146689: Mavacamten: Real-World Experience from 22 Months of the Risk Evaluation and Mitigation Strategy (REMS) Program

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recommendations! Published in 2024 at "Circulation"

DOI: 10.1161/circ.150.suppl_1.4146689

Abstract: Introduction: Mavacamten is a cardiac myosin inhibitor approved by the US FDA for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms. Under… read more here.

Keywords: evaluation mitigation; risk evaluation; program; rems program ... See more keywords

Analysis of risk evaluation and mitigation strategies for teratogenic drugs: Variation in primary and secondary prevention measures

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recommendations! Published in 2023 at "PLOS Medicine"

DOI: 10.1371/journal.pmed.1004190

Abstract: In an analysis of risk evaluation and mitigation strategies for teratogenic drugs, Ameet Sarpatwari, Beatrice Brown and Aaron Kesselheim explore the variation in primary and secondary prevention measures. read more here.

Keywords: risk evaluation; analysis risk; teratogenic drugs; mitigation strategies ... See more keywords

Impact Of Risk Evaluation And Mitigation Strategies On Generic Approvals Of US Pharmaceutical Products.

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recommendations! Published in 2025 at "Health affairs"

DOI: 10.1377/hlthaff.2024.01476

Abstract: Risk evaluation and mitigation strategy (REMS) programs help ensure that the benefits of certain high-risk medications outweigh their risks. With the routine use of REMS programs, however, concerns have emerged that they may delay the… read more here.

Keywords: risk evaluation; evaluation mitigation; risk; generic approvals ... See more keywords

Turalio risk evaluation and mitigation strategy for treatment of tenosynovial giant cell tumor: framework and experience.

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recommendations! Published in 2022 at "Future oncology"

DOI: 10.2217/fon-2021-1475

Abstract: For drugs with enhanced serious safety risks, Risk Evaluation and Mitigation Strategy (REMS) may be required. Pexidartinib is approved for treatment of adult symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional… read more here.

Keywords: risk evaluation; cell tumor; giant cell; mitigation strategy ... See more keywords

In Vitro Evaluation and Mitigation of Niclosamide’s Liabilities as a COVID-19 Treatment

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recommendations! Published in 2022 at "Vaccines"

DOI: 10.3390/vaccines10081284

Abstract: Niclosamide, an FDA-approved oral anthelmintic drug, has broad biological activity including anticancer, antibacterial, and antiviral properties. Niclosamide has also been identified as a potent inhibitor of SARS-CoV-2 infection in vitro, generating interest in its use… read more here.

Keywords: cell; mitigation niclosamide; sars cov; vitro evaluation ... See more keywords