Risk Evaluation and Mitigation
"Risk Evaluation and Mitigation" is a descriptor in the National Library of Medicine's controlled vocabulary thesaurus,
MeSH (Medical Subject Headings). Descriptors are arranged in a hierarchical structure,
which enables searching at various levels of specificity.
Strategies required by the US Food and Drug Administration (FDA) Amendments Act of 2007 when a question exists as to whether the benefits of a drug outweigh its risks. These constitute a safety plan with several potential components, including a medication guide, a communication plan, elements to ensure safe use and an implementation system to help guide the prescribers, pharmacists and patients.
| Descriptor ID |
D000073938
|
| MeSH Number(s) |
N04.452.871.758 N06.850.505.715.750
|
| Concept/Terms |
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Below are MeSH descriptors whose meaning is more general than "Risk Evaluation and Mitigation".
Below are MeSH descriptors whose meaning is more specific than "Risk Evaluation and Mitigation".
This graph shows the total number of publications written about "Risk Evaluation and Mitigation" by people in this website by year, and whether "Risk Evaluation and Mitigation" was a major or minor topic of these publications.
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| Year | Major Topic | Minor Topic | Total |
|---|
| 2020 | 0 | 1 | 1 |
| 2021 | 1 | 1 | 2 |
| 2024 | 0 | 1 | 1 |
| 2026 | 1 | 0 | 1 |
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Below are the most recent publications written about "Risk Evaluation and Mitigation" by people in Profiles.
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US Risk Evaluation and Mitigation Strategies with Elements to Assure Safe Use: A Longitudinal Analysis of REMS Modifications (2008-2022). Drug Saf. 2026 Jul; 49(7):829-841.
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The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE). Drug Saf. 2024 Jul; 47(7):655-671.
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Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014-2018). BMC Health Serv Res. 2021 Aug 06; 21(1):779.
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Federal, state, and institutional barriers to the expansion of medication and telemedicine abortion services in Ohio, Kentucky, and West Virginia during the COVID-19 pandemic. Contraception. 2021 07; 104(1):111-116.
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Adaptation for Regulatory Application: A Content Analysis of FDA Risk Evaluation and Mitigation Strategies Assessment Plans (2014-2018) Using RE-AIM. Front Public Health. 2020; 8:43.