中国临床药理学杂志2025，Vol.41Issue(17)：2544-2550,7.DOI:10.13699/j.cnki.1001-6821.2025.17.025
美国食品药品监督管理局专家咨询委员会工作程序介绍
Introduction to the procedure of the United States Food and Drug Administration advisory committee
张帆 1侯健 1王宇涛 1许真玉1
作者信息
- 1. 国家药品监督管理局 药品审评中心,北京 100076
- 折叠
摘要
Abstract
In order to ensure regulatory decisions in numerous fields such as pharmaceuticals,medical devices and food are scientific,fair and reasonable,the United States Food and Drug Administration(FDA)has established a comprehensive advisory committee system through a long-term exploration and practice.The advisory committee can provide independent opinions and suggestions on a series of complex scientific,technical and policy issues,making significant contributions to the FDA's decision-making process.This article introduces the basic information of the FDA advisory committees,providing a detailed knowledge of the specific procedures and requirements for submitting meeting requests,conducting pre-meeting preparations,organizing meetings,drafting post-meeting minutes,facilitating internal discussions and delivering meeting feedback.All of these are aimed at providing references and insights for further optimizing and improving the expert consultation system in China.关键词
美国食品药品监督管理局/专家咨询委员会/工作程序/政策法规Key words
the United States Food and Drug Administration/advisory committee/procedure/policy分类
药学引用本文复制引用
张帆,侯健,王宇涛,许真玉..美国食品药品监督管理局专家咨询委员会工作程序介绍[J].中国临床药理学杂志,2025,41(17):2544-2550,7.
