摘要
收集并比较美国食品药品管理局(FDA)和我国国家食品药品监督管理局(CFDA)网站公布的、从2008年至今有关更新氟喹诺酮类药物说明书安全性信息的指令。结果发现我国发布的该方面指令较FDA的次数少,涉及品种和内容均少于FDA,提示我国应加强和加速氟喹诺酮类药品和其他上市药品说明书的更新工作。
The directives on updated safety information of fluoroquinolones label issued on the FDA and CFDA websites from 2008 to date are collected and compared. Compared with FDA, the number of directives is less, the involving drugs are less and the content is less also in our country are found. It is suggested that the update of the postmarketing drug label should be strengthened and accelerated in our country.
出处
《药物评价研究》
CAS
2016年第6期919-924,共6页
Drug Evaluation Research
