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Mathematical Concepts > Probability > Risk > Risk Assessment > Risk Evaluation and Mitigation

Preferred term

Risk Evaluation and Mitigation  

Type

  • Topical Descriptor

Broader concept

Entry terms

  • Elements to Assure Safe Use

Scope note

  • 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.

History note

  • 2018

In other languages

URI

http://www.yso.fi/onto/mesh/D000073938

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