FDA Launches Roadmap to Phase Out Animal Testing in Drug Development

The agency will implement advanced human-relevant methods, including AI and lab-grown organoids, starting with a pilot program for monoclonal antibody therapies.

The FDA announced plans to phase out animal testing requirements for monoclonal antibodies and other drugs, replacing them with human-relevant testing methodologies.
A pilot program will allow select drug developers to use non-animal testing approaches, with the potential for streamlined reviews for strong safety data.
New Approach Methodologies (NAMs) include AI-based toxicity simulations, lab-grown human organoids, and organ-on-a-chip systems to improve drug safety predictions.
The initiative builds on the FDA Modernization Act 2.0, which eliminated the mandatory requirement for animal testing in 2023, marking a significant regulatory shift.
Biotech stocks surged following the announcement, while companies relying on animal testing, such as Charles River Laboratories, experienced market declines.