The US Food and Drug Administration (FDA) plans to phase out animal testing requirements for antibody therapies and other drugs, shifting towards AI-based models and tools deemed “human-relevant.” The agency aims to improve drug safety, reduce research costs, and address ethical concerns about animal experimentation.
A pilot program will allow select developers of monoclonal antibodies to use non-animal based testing strategies. This initiative is part of the FDA’s effort to reaffirm its role as a leader in modern regulatory science amid cuts to the agency that have raised concerns about timely product reviews.
The new approach involves using computer modeling and AI to predict drug behavior and potential side effects, as well as lab-grown human “organoids” and “organ-on-a-chip” technology to test drug safety. Companies that submit strong safety data from non-animal tests may receive streamlined product reviews.
PETA has hailed the move as a significant step towards replacing animal testing. The FDA’s roadmap envisions improved efficiency, reduced costs, and increased efficacy in evaluating drugs. Pharmaceutical companies are cautiously optimistic about the new approach, with some stocks rising on the news.
Source: https://www.axios.com/2025/04/10/fda-animal-testing-drug-trials