Article(id=1321425799345979820, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425746170597545, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.13.001, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1761494400000, acceptedDateStr=2025-10-27, onlineDate=1792982061467, onlineDateStr=2026-10-26, pubDate=1784044800000, pubDateStr=2026-07-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982061467, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982061467, creator=13701087609, updateTime=1792982061467, updator=13701087609, issue=Issue{id=1321425746170597545, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='13', pageStart='1345', pageEnd='1456', issueExtLink='null', onlineDate='null', pubDate='1784044800000', pubDateStr='2026-07-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982048790, creator='13701087609', updateTime=1792982953102, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321429539205534609, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425746170597545, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321429539205534610, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425746170597545, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1345, endPage=1351, ext={EN=ArticleExt(id=1321425799551500717, articleId=1321425799345979820, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=FDA pathways to enhance evidence generation and information transparency for geriatric medication, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

With the accelerating global of population aging, medication safety in older adults has become a global public health concern. This study focuses on three major challenges in geriatric pharmacotherapy: insufficient enrollment of elderly patients in clinical trials, a relative lack of pharmacokinetic studies in older populations, and incomplete geriatric use information in drug labeling. It then systematically reviews the multi-tiered policy support framework established by the U.S. Food and Drug Administration (FDA) to address these challenges. Key measures within this framework include optimizing clinical trial eligibility criteria, reducing barriers to patient participation, and implementing the "Drug Trials Snapshots" program, which have collectively improved evidence generation and information communication mechanisms for geriatric medication use. Based on China's national context, the study further discusses three core areas: clinical trial design optimization, pharmacokinetic research enhancement, and drug information transparency.

, authors=Hai-bo WEI^{1, 2, 3}, Yang XU^{2, 3}, Jing DING^{2, 3, 4}, Yue YANG^{2, 3, *}, authorsList=Hai-bo WEI, Yang XU, Jing DING, Yue YANG, authorCompany=null, correspAuthors=Yue YANG, 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=1321425799798964654, articleId=1321425799345979820, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=美国FDA推动老年用药证据优化与信息公开路径, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

随着人口老龄化进程的加快，老年人群的用药安全已成为全球公共卫生领域关注的焦点。本研究聚焦当前老年人群用药面临的三大挑战：临床试验中老年患者纳入不足、老年人群的药动学研究相对缺乏以及药品说明书中老年用药信息不完整，系统回顾了美国FDA为应对这些挑战构建的多层次政策支持体系。该体系重点涵盖优化临床试验资格标准、减少患者参与障碍、实施“药物试验快照”计划等关键举措，逐步完善了老年人群用药的证据生成与信息传递机制。结合我国国情，进一步在临床试验设计优化、药动学研究及药品信息透明化三大核心领域展开讨论。

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²School of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China
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³国家药品监督管理局创新药物研究与评价重点实验室，北京 100084, bio={"content":"

尉海波，男，硕士研究生，研究方向：药品监管科学与药物政策研究。E-mail: whb_4767@163.com。

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尉海波，男，硕士研究生，研究方向：药品监管科学与药物政策研究。E-mail: whb_4767@163.com。

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