Health Care [N] » Health Services Administration [N04] » Organization and Administration » Risk Management » Risk Evaluation and Mitigation
Health Care [N] » Environment and Public Health [N06] » Public Health » Epidemiologic Measurements » Risk Assessment » Risk Evaluation and Mitigation
Description
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. MeSH
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