FDA

FDA to phase out animal testing for monoclonal antibodies and other drugs

April 16, 2025

FDA is phasing out animal testing in the development of monoclonal antibody therapies and other drugs, replacing it with more effective, human-relevant methods. This initiative aims to improve drug safety and expedite the evaluation process, while reducing animal experimentation, lowering research and development costs, and ultimately decreasing drug prices.

A range of approaches will be implemented to reduce, refine, or potentially replace animal testing, including AI-based computational models and cell lines and organoid toxicity testing (i.e., New Approach Methodologies or NAMs data). This new regimen will be applied immediately to investigational new drug applications, encouraging the inclusion of NAMs data.

Additionally, the agency will utilize pre-existing, real-world safety data from other countries with comparable regulatory standards to determine efficacy. Commissioner Martin A. Makary emphasized that this initiative marks a paradigm shift in drug evaluation, promising faster and safer treatments for patients while significantly reducing animal use. This move also represents a major step forward for animal welfare, potentially saving thousands of dogs and primates from lab testing each year.

Source:

(2025, April 10). FDA. FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs. https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs