TY - JOUR
KW - Computational biology and bioinformatics
KW - Drug Discovery
KW - medical research
AU - Ashley L. Eadie
AU - Holly Fernandez Lynch
AU - Naomi Scheinerman
AU - Ravi B. Parikh
AB - In 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.
BT - npj Digital Medicine
DA - 2026-04-15
DO - 10.1038/s41746-026-02476-x
LA - en
N2 - In 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.
PY - 2026
T2 - npj Digital Medicine
TI - Advancing FDA New Approach Methodologies from animal models through digital twins
UR - https://www.nature.com/articles/s41746-026-02476-x
Y2 - 2026-04-20
SN - 2398-6352
ER -