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 WEI1, 2, 3, Yang XU2, 3, Jing DING2, 3, 4, Yue YANG2, 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。

, authors=尉海波1, 2, 3, 徐杨2, 3, 丁静2, 3, 4, 杨悦2, 3, *, authorsList=尉海波, 徐杨, 丁静, 杨悦, authorCompany=null, correspAuthors=杨悦, authorNote=

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: 。

, correspAuthorsNote=
* 杨悦,女,研究员,博士生导师,研究方向:药品监管科学与法律政策研究。E-mail: 。
, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=dW8ZBYOuYWKlu4Ht6ihW8Q==, magXml=iD39wWF1ZAr5mLxVgnNkxA==, pdfUrl=null, pdf=2Uz+BiWtcQjsjnjvP4D4Ow==, pdfFileSize=2298277, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=4tl27hUoDppRm2G/TsvPkg==, mapNumber=null, fund=null)}, authors=[Author(id=1321425800465859004, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425799345979820, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=whb_4767@163.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1321425800549745088, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425799345979820, authorId=1321425800465859004, language=EN, stringName=Hai-bo WEI, firstName=Hai-bo, middleName=null, lastName=WEI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, 2, 3, address=1School of Biomedical Engineering, Hainan University, Sanya 572024, China
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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: 。

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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: 。

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美国FDA推动老年用药证据优化与信息公开路径
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尉海波 1, 2, 3 , 徐杨 2, 3 , 丁静 2, 3, 4 , 杨悦 2, 3, *
中国新药杂志 | 新药述评与论坛 2026,35(13): 1345-1351
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中国新药杂志 |新药述评与论坛 2026 , 35 (13) : 1345 -1351
美国FDA推动老年用药证据优化与信息公开路径
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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: 。

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尉海波1, 2, 3 , 徐杨2, 3, 丁静2, 3, 4, 杨悦2, 3, *
作者信息
  • 1海南大学生物医学工程学院,三亚 572024
  • 2清华大学药学院,北京 100084
  • 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
  • 4沈阳药科大学工商管理学院,沈阳 110016
通讯作者:
* 杨悦,女,研究员,博士生导师,研究方向:药品监管科学与法律政策研究。E-mail: 。
作者简介:

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: 。

FDA pathways to enhance evidence generation and information transparency for geriatric medication
Hai-bo WEI1, 2, 3 , Yang XU2, 3, Jing DING2, 3, 4, Yue YANG2, 3, *
Affiliations
  • 1School of Biomedical Engineering, Hainan University, Sanya 572024, China
  • 2School of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China
  • 3Key Laboratory for Research and Evaluation of Innovative Drug, National Medical Products Administration, Beijing 100084, China
  • 4School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
出版时间: 2026-07-15 doi: 10.20251/j.cnki.1003-3734.2026.13.001
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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。

老年用药  /  FDA  /  临床试验  /  药品监管

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.

geriatric pharmacotherapy  /  FDA  /  clinical trials  /  drug regulation
尉海波, 徐杨, 丁静, 杨悦. 美国FDA推动老年用药证据优化与信息公开路径. 中国新药杂志, 2026 , 35 (13) : 1345 -1351 . DOI: 10.20251/j.cnki.1003-3734.2026.13.001
Hai-bo WEI, Yang XU, Jing DING, Yue YANG. FDA pathways to enhance evidence generation and information transparency for geriatric medication[J]. Chinese Journal of New Drugs, 2026 , 35 (13) : 1345 -1351 . DOI: 10.20251/j.cnki.1003-3734.2026.13.001
  • 药品监管科学全国重点实验室课题资助项目(2023SKLDRS0141)
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2026年第35卷第13期
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doi: 10.20251/j.cnki.1003-3734.2026.13.001
  • 首发时间:2026-10-26
  • 出版时间:2026-07-15
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  • 录用日期:2025-10-27
基金
药品监管科学全国重点实验室课题资助项目(2023SKLDRS0141)
作者信息
    1海南大学生物医学工程学院,三亚 572024
    2清华大学药学院,北京 100084
    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
    4沈阳药科大学工商管理学院,沈阳 110016

通讯作者:

* 杨悦,女,研究员,博士生导师,研究方向:药品监管科学与法律政策研究。E-mail: 。
参考文献
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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