Concept information
Preferred term
Risk Evaluation and Mitigation
Type
-
mesh:Descriptor
Definition
- 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.
Broader concept
Allowable Qualifier(s)
In other languages
URI
http://data.loterre.fr/ark:/67375/JVR-W46K7JDD-D
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