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FDA pathways to enhance evidence generation and information transparency for geriatric medication
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Hai-bo WEI1, 2, 3, Yang XU2, 3, Jing DING2, 3, 4, Yue YANG2, 3, *
Chinese Journal of New Drugs | 2026, 35(13) : 1345 - 1351
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Chinese Journal of New Drugs | 2026, 35(13): 1345-1351
FDA pathways to enhance evidence generation and information transparency for geriatric medication
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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
Published: 2026-07-15 doi: 10.20251/j.cnki.1003-3734.2026.13.001
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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
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Year 2026 volume 35 Issue 13
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Article Info
doi: 10.20251/j.cnki.1003-3734.2026.13.001
  • Online Date：2026-10-26
  • Published：2026-07-15
Article Data
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History
  • Accepted：2025-10-27
Funding
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
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https://castjournals.cast.org.cn/joweb/zgxyzz/EN/10.20251/j.cnki.1003-3734.2026.13.001
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