Advancing FDA New Approach Methodologies from animal models through digital twins.
expert_opinion · Level V
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- Record sourced from PubMed, PMID 41986448.
- Also identified by DOI 10.1038/s41746-026-02476-x.
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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)-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.