Advancing FDA New Approach Methodologies from animal models through digital twins

This commentary responds to the FDA's April 2025 announcement of immediate steps toward replacing animal testing with New Approach Methodologies, modern laboratory techniques designed to better mimic human biology. While welcoming the policy shift, the authors argue that significant gaps remain between current regulatory frameworks and the technologies' practical promise, and that specific, comprehensive regulatory reforms are needed to facilitate a responsible transition. The piece lays out a reform agenda aimed at building the regulatory groundwork necessary for digital twins, in silico trials, and related innovations to function as credible and actionable alternatives to animal models in drug evaluation.

These arguments carry substantial implications for the future of precision medicine and drug safety. Replacing animal models with human-relevant computational and biological systems has the potential to accelerate development timelines, reduce costs, and generate data more predictive of how therapies will perform in actual patients. The authors' focus on regulatory infrastructure underscores that the technology itself is only part of the challenge, and that durable progress requires building the institutional trust and oversight mechanisms necessary for these methods to earn their place in evidence-based drug approval.