Longitudinal Safety: An intentional gap? (policy)

The integration of longitudinal genetic and epigenetic studies into routine pharmaceutical safety evaluation is a critical and glaring knowledge gap that demands urgent attention within drug development and post-marketing surveillance pipelines. Despite the rapid advancement in genetic, epigenetic, and neuro- sciences enabling unprecedented molecular insight, current safety assessments largely overlook the cumulative and nuanced molecular impacts of chronic drug exposure, thereby potentially perpetuating unforeseen risks to patient safety and public health. This lack of progressive integration underscores profound ethical and scientific shortcomings that risk undermining both patient trust and optimal therapeutic outcomes.