摘要:美国食品药品管理局(FDA)于2019年07月了“人用处方药和生物制品说明书的药物滥用和依赖项目--内容和格式供企业用指导原则”(草案).该指导原则介绍了撰写药物滥用和药物依赖项目的一般原则以及对其中管制物质、滥用和依赖性3个小项的撰写要求.而我国目前尚无类似指导原则,详细介绍该指导原则,期望对我国说明书这部分内容的撰写和监管有帮助.
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