Concept information
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
-
Finnish
-
riskin arviointi ja pienentäminen
-
Swedish
URI
http://www.yso.fi/onto/mesh/D000073938
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