中国药物警戒 ›› 2013, Vol. 10 ›› Issue (8): 460-463.

• 政策与法规研究 • 上一篇    下一篇

FDA关于处方药说明书[注意事项]、[禁忌]和[警示语]的要求

萧惠来   

  1. 国家食品药品监督管理局药品审评中心,北京 100038
  • 收稿日期:2013-02-21 修回日期:2016-03-09 出版日期:2013-08-08 发布日期:2016-03-09
  • 作者简介:萧惠来,男,教授,注册药品的非临床药理毒理评价。

FDA's Requirements for Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Prescription Drug

XIAO Hui-lai   

  1. Center for Drug Evaluation, SFDA, Beijing 100038, China
  • Received:2013-02-21 Revised:2016-03-09 Online:2013-08-08 Published:2016-03-09

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摘要： FDA 的“人用处方药和生物制品说明书的[警告和注意事项]、[禁忌]和[加框警告]部分的指导原则”,详细地描述了对说明书此3 个项目内容和形式的要求。我国目前未有类似指导原则,通过介绍其主要内容,以期为我国的说明书撰写者和审评者提供参考和借鉴。

关键词: FDA, 指导则, 处方药说明书, 注意事项, 禁忌, 警示语

Abstract: The requirements for warnings and precautions, contraindications and boxed warning of labeling are described specifically in FDA's "Guidance for Industry Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products-Content and Format". There is no similar guidance in our country. The primary content of it is introduced in this article. It is expected to assist the writers and reviewers of labeling. Key words: Food and Drug Administration; guidance; labeling for prescription drug; warnings and precautions; contraindications; boxed warning

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