Risk Evaluation and Mitigation Strategy (REMS)
REMSAn FDA-required safety program for drugs with known serious risks. May include medication guides, communication plans, or elements to assure safe use (ETASU) such as restricted distribution.
Примеры
- iPLEDGE for isotretinoin
- Clozapine REMS
- Opioid REMS (education-based)
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An FDA-required safety program for drugs with known serious risks. May include medication guides, communication plans, or elements to assure safe use (ETASU) such as restricted distribution.