@article{bibcite_7696,
  keywords = {Computational biology and bioinformatics, Drug Discovery, medical research},
  author = {Ashley L. Eadie and Holly Fernandez Lynch and Naomi Scheinerman and Ravi B. Parikh},
  title = {Advancing FDA New Approach Methodologies from animal models through digital twins},
  abstract = {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){\textemdash}modern laboratory techniques mimicking human tissues. However, significant gaps exist between current regulatory frameworks and these technologies{\textquoteright} 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.},
  year = {2026},
  journal = {npj Digital Medicine},
  month = {2026-04-15},
  issn = {2398-6352},
  url = {https://www.nature.com/articles/s41746-026-02476-x},
  doi = {10.1038/s41746-026-02476-x},
  language = {en},
}