FDA to phase out animal testing with AI and lab-based models

The article discusses the FDA’s plan to phase out animal testing in drug development, introducing advanced methods like AI models and lab-based systems such as organ-on-a-chip. This initiative, driven by the 2022 FDA Modernization Act, aims to enhance drug safety, reduce costs, and expedite treatments, starting with monoclonal antibodies (mAbs). The approach includes accepting data from non-animal testing methodologies and real-world safety data from comparable regulatory environments. The move signifies a paradigm shift, fostering progress in human-relevant drug testing while improving animal welfare.

Published: April 11, 2025