FDA对异维A酸事件实施风险干预的案例研究

摘要

Based on “Development and use of risk minimization action plan”, we analyzed the special risk intervene of isotretinoin. FDA adopted a forcing risk management plan for isotretinoin. This is important and will support the intervention capacity of drug safe in our country.%文中通过学习FDA,分析了FDA对异维A酸事件的特殊风险干预措施,FDA根据RiskMAP对异维A酸采取了iPLEDGE这一强制型风险管理计划,对我国处理类似事件具有重要的借鉴意义,为提高我国今后对药品安全风险的干预能力提供了支持.