Health Care

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.

National Library of MedicineMedical Subject Headings2026

Structured Summary

Abstract

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 Record

Classification

Broader headings

Related Concepts

Knowledge Graph

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MeSH Record

Synonyms

2 entry terms
  • ETASU
  • Elements to Assure Safe Use

MeSH Record

Aspects Covered

3 allowable subheadings

Indexed with the subheadings legislation & jurisprudence, organization & administration, standards.

MeSH Record

History Note

2018

MeSH Record

Previous Indexing

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

MeSH Hierarchy

Tree Numbers

  1. N04w.452.871w.758w
  2. N06.850w.505.715w.750w

MeSH Record

NLM Classification

QV 771

AMA Style

References

  1. National Library of Medicine. Risk Evaluation and Mitigation. Medical Subject Headings (MeSH). 2026. Unique ID D000073938. http://id.nlm.nih.gov/mesh/2026/D000073938
  2. Risk Evaluation and Mitigation. In: Wikipedia. https://en.wikipedia.org/wiki/Risk_Evaluation_and_Mitigation_Strategies
  3. Risk Evaluation and Mitigation. In: Wikidata. https://www.wikidata.org/wiki/Q55631740