The FDA has unveiled a roadmap aiming to phase out animal testing in drug development within three to five years, leveraging advanced human cell-based assays, organoid technologies, and AI-driven computational models. This ambitious plan builds on recent legislative changes such as the FDA Modernization Act 2.0 and anticipated FDA Modernization Act 3.0, which support the use of non-animal approaches. However, the transition faces challenges related to validation, regulatory adaptation, and technological hurdles, underscored by the ongoing tension between ethical concerns and ensuring drug safety and efficacy.