01161nas a2200205   4500000000100000000000100001008004100002260001500043653004500058653001900103653002100122100002000143700002600163700002200189700001900211245008600230856005500316520057000371022001400941       2026                            d  c2026-04-1510aComputational biology and bioinformatics10aDrug Discovery10amedical research1 aAshley L. Eadie1 aHolly Fernandez Lynch1 aNaomi Scheinerman1 aRavi B. Parikh00aAdvancing FDA New Approach Methodologies from animal models through digital twins  uhttps://www.nature.com/articles/s41746-026-02476-x3 aIn April 2025, the U.S. Food and Drug Administration announced immediate steps toward replacing animal testing for drug evaluation with New Approach Methodologies (NAMs)—modern laboratory techniques mimicking human tissues. However, significant gaps exist between current regulatory frameworks and these technologies’ promise. We argue that specific comprehensive regulatory reforms will improve transition to human-relevant drug-evaluation methodologies, laying groundwork for digital twins, in silico trials, and transformative advances in precision medicine.  a2398-6352