Work

Advancing FDA New Approach Methodologies from animal models through digital twins

Year: 2026

Type: article

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.

Source: npj Digital Medicine

DOI: 10.1038/s41746-026-02476-x

Authors: Ashley L. Eadie, Holly Fernandez Lynch, Naomi Scheinerman, Ravi B. Parikh

Institutions: Emory University, University of Pennsylvania, The Ohio State University

Language: English

Topic: Animal testing and alternatives

Subfield: Small Animals

Field: Veterinary

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $4,090