In a landmark move, the FDA has announced plans to phase out animal testing requirements for monoclonal antibodies (mAbs) and other therapeutics, marking a significant shift in drug development. This initiative builds on the momentum of the FDA Modernization Act 2.0 and leverages cutting-edge New Approach Methodologies (NAMs), such as organ-on-chip technologies, advanced in vitro assays, and AI-driven modeling. Starting with mAbs, where traditional animal models have repeatedly failed to predict human outcomes—as in the notorious TGN1412 case—the FDA aims to reduce reliance on costly and ethically contentious animal studies. This strategic roadmap not only promises faster, safer, and more human-relevant drug development but also positions the FDA as a global leader in regulatory innovation
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