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

Summary

The FDA has formally put its Roadmap to Reducing Animal Testing into effect, moving drug development toward New Approach Methodologies known as NAMs. Organ on a chip systems and in silico models are specifically named as NAM alternatives for preclinical safety evaluation. The move formalizes regulatory acceptance of these methods as recognized new approaches. The shift is meant to generate more human relevant data and reduce the share of drugs that pass animal testing yet fail in human trials. The material also references a 2025 draft FDA guidance on using AI across the drug lifecycle as part of the broader regulatory direction.