International: FDA to Phase Out Animal Testing for Monoclonal Antibodies and Other Drugs

On 10 April 2025, the U.S. Food and Drug Administration (FDA) announced a plan to phase out animal testing requirements for monoclonal antibodies and other drugs. The agency will encourage the use of New Approach Methodologies (NAMs), including AI-based models and lab-engineered human organ-like structures, to improve drug safety and reduce development costs. This initiative aims to accelerate the availability of treatments while minimizing animal use. Effective immediately, the FDA will promote the submission of non-animal safety data for human trial applications, offering incentives like streamlined reviews for strong non-animal evidence. A pilot program over the next year will allow selected developers to test antibody-based drugs using NAMs, with findings informing future regulatory changes. The FDA's move aligns with the FDA Modernization Act 2.0, signed into law in 2022, which removed the mandate for animal testing in drug development. The agency plans to collaborate with federal partners to validate and adopt these innovative methods through the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). A public workshop will be held later this year to discuss the roadmap and gather stakeholder input on its implementation.