[關(guān)鍵詞]
[摘要]
收集并比較美國(guó)食品藥品管理局(FDA)和我國(guó)國(guó)家食品藥品監(jiān)督管理局(CFDA)網(wǎng)站公布的、從2008年至今有關(guān)更新氟喹諾酮類藥物說(shuō)明書安全性信息的指令。結(jié)果發(fā)現(xiàn)我國(guó)發(fā)布的該方面指令較FDA的次數(shù)少,涉及品種和內(nèi)容均少于FDA,提示我國(guó)應(yīng)加強(qiáng)和加速氟喹諾酮類藥品和其他上市藥品說(shuō)明書的更新工作。
[Key word]
[Abstract]
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.
[中圖分類號(hào)]
[基金項(xiàng)目]