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DeCS
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Descriptor English:
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Risk Evaluation and Mitigation
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Descriptor Spanish:
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evaluación y mitigación de riesgos
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Descriptor Portuguese:
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Avaliação de Risco e Mitigação
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Synonyms English:
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ETASU
Elements to Assure Safe Use
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Tree Number:
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N04.452.871.758
N06.850.505.715.750
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Definition English:
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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. |
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History Note English:
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2018
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Allowable Qualifiers English:
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Record Number:
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57335
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Unique Identifier:
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D000073938
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Occurrence in VHL:
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Similar:
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DeCS
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