strategie hodnocení a snižování rizika (USA) [Risk Evaluation and Mitigation]
- Termíny
-
REMS
-
Elements to Assure Safe Use
ETASU
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.
- DUI
- D000073938 MeSH Prohlížeč
- CUI
- M000625026
- Předchozí užití
- Risk Assessment (2009-2017); Risk Management (2008-2017)
- Historická pozn.
- 2018
- Veřejná pozn.
- 2018
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