In April 2025, the FDA unveiled an ambitious plan to phase out animal testing in drug development within three to five years, aiming to adopt more human-relevant methods such as AI-driven computational models and advanced human cell culture techniques. This initiative builds on the FDA Modernization Act 2.0 passed in 2022, which authorized the use of alternative data for drug safety assessment. Despite ethical and scientific concerns about animal testing's predictive limitations, there is scrutiny on the actual progress, leading Congress to consider additional legislation to compel further changes. The FDA’s new regulatory approach seeks to reduce costs and development timelines while enhancing drug safety evaluations.