Regulatory Blog

Artificial intelligence (AI) is rapidly becoming an important part of healthcare, drug development, and regulatory operations. To modernize its internal systems and improve operational efficiency, the U.S. Food and Drug Administration (FDA) announced major upgrades to its AI infrastructure and data management capabilities. On May 6, 2026, the FDA announced the launch of Elsa 4.0, an upgraded version of its internal AI tool, along with the completion of a large-scale data plat