Risk Evaluation and Mitigation

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.

Year introduced: 2018

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Tree Number(s): N04.452.871.758, N06.850.505.715.750

MeSH Unique ID: D000073938

Entry Terms:

• Elements to Assure Safe Use
• ETASU

Previous Indexing:

• Risk Assessment (2009-2017)
• Risk Management (2008-2017)

All MeSH Categories
Health Care Category
Health Services Administration
Organization and Administration
Risk Management
Risk Evaluation and Mitigation

All MeSH Categories
Health Care Category
Environment and Public Health
Public Health
Epidemiologic Measurements
Risk Assessment
Risk Evaluation and Mitigation