What question did this study set out to answer?

The aim is to address gaps in regulatory frameworks for replacing animal testing with modern methodologies.

April 18, 2026npj Digital MedicineOpen Access

Advancing FDA New Approach Methodologies from animal models through digital twins

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Regulatory reforms enhance human-relevant drug evaluation with digital twins and precision medicine.

The aim is to address gaps in regulatory frameworks for replacing animal testing with modern methodologies.
Examined current FDA regulations
Proposed specific reforms for adopting NAMs
Discussed the implementation of digital twins and in silico trials
Identified significant gaps in existing regulatory frameworks
Highlighted the potential of NAMs to improve drug evaluation
Outlined how digital twins could transform precision medicine

Eadie et al. (2026) studied this question.

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