FDA pathways to enhance evidence generation and information transparency for geriatric medication
WEI Hai-bo
XU Yang
DING Jing
YANG Yue
Abstract：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.
Keywords：geriatric pharmacotherapyFDAclinical trialsdrug regulation
Publication Date：2026-07-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 1345-1351 )