FDA Roadmap to reducing animal testing in preclinical safety studies
In April 2025, FDA published a “Roadmap to Reducing Animal Testing in Preclinical Safety Studies.” This roadmap outlines a strategic, stepwise approach for FDA to reduce animal testing in preclinical safety studies with scientifically validated NAMs, such as organ-on-a-chip systems, computational modeling, and advanced in vitro assays. By partnering with federal agencies including NIH and VA ORD through ICCVAM, FDA can accelerate the validation and adoption of these human-relevant methods, improving predictive accuracy while reducing animal use. This transition will enhance public health by streamlining drug development and ensuring safer therapies reach patients faster, while positioning FDA as a global leader in modern regulatory science and innovation.
The initial focus in implementing the roadmap is a pilot program that allows select monoclonal antibody developers to use a primarily nonanimal-based testing strategy under close FDA consultation. Findings from an accompanying pilot study will inform broader policy changes, and guidance updates are expected to roll out in phases.