Signal FDA's Roadmap to Reducing Animal Testing — New Approach Methodologies in drug development

Summary

The FDA has formally implemented its Roadmap to Reducing Animal Testing, transitioning toward New Approach Methodologies (NAMs) in drug development. Organ-on-a-chip systems and in silico models are specifically named as NAM alternatives for preclinical safety evaluation. The shift is intended to improve translational fidelity by generating more human-relevant data, with an expected outcome of reducing the rate at which drugs that pass animal trials go on to fail in human trials. The source also references a 2025 draft FDA guidance on AI in the drug lifecycle as part of the broader regulatory direction.