Article(id=1291704881631486262, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704771212234905, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.17.025, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1748880000000, receivedDateStr=2025-06-03, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896042496, onlineDateStr=2026-08-05, pubDate=1758038400000, pubDateStr=2025-09-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896042496, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896042496, creator=13701087609, updateTime=1785896042496, updator=13701087609, issue=Issue{id=1291704771212234905, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='17', pageStart='2401', pageEnd='2550', issueExtLink='null', onlineDate='null', pubDate='1758038400000', pubDateStr='2025-09-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896016147, creator='13701087609', updateTime=1785896900366, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291708479866164175, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704771212234905, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291708479866164176, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704771212234905, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2544, endPage=2550, ext={EN=ArticleExt(id=1291704883586031927, articleId=1291704881631486262, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Introduction to the procedure of the United States Food and Drug Administration advisory committee, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

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.

, authors=Fan ZHANG, Jian HOU, Yu-tao WANG, Zhen-yu XU, authorsList=Fan ZHANG, Jian HOU, Yu-tao WANG, Zhen-yu XU, authorCompany=null, correspAuthors=Zhen-yu XU, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291704884781408568, articleId=1291704881631486262, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=美国食品药品监督管理局专家咨询委员会工作程序介绍, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

为了确保在药品、医疗器械、食品等诸多领域监管决策的科学、公正、合理，美国食品药品监督管理局（FDA）经过长期探索与实践，建立了完善的专家咨询委员会制度。专家咨询委员会可以针对复杂的科学、技术及政策问题等提供独立的意见建议，为FDA的决策做出了重要贡献。本文介绍了FDA专家咨询委员会的基本情况，详细梳理了专家咨询委员会会议申请的提出、会前的筹备、会议组织召开、会后纪要起草、内部讨论、会议反馈等具体环节和要求，为进一步推动优化我国专家咨询制度提供借鉴和参考。

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张帆（1990-），女，主管药师，主要从事药品审评项目管理与药品政策法规相关工作

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张帆（1990-），女，主管药师，主要从事药品审评项目管理与药品政策法规相关工作

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