Beyond the Cage: How the FDA Modernization Act is Accelerating the Shift Toward Human-Based Models

The FDA Modernization Act 2.0 has opened the door to a new era in preclinical research — one powered by organoids, organs-on-chips, iPSC systems, ex vivo human tissues, and AI-driven prediction tools. As regulators push for human-relevant science, these technologies are reshaping how drugs are designed, tested, and brought to patients. This article explores how and why the shift is accelerating.