FDA Launches Elsa 4.0, HALO Platform

The United States — Food and Drug Administration has announced significant steps to modernize its operations by launching Elsa 4.0, an upgraded internal AI tool, and consolidating over 40 disparate data sources into a new platform called HALO (Harmonized AI & Lifecycle Operations for Data). Elsa 4.0, available to all United States — Food and Drug Administration staff, introduces features like custom agents, document generation, quantitative data analysis, and secure web search. The integration of HALO and Elsa is designed to enable staff to query data and build workflows more efficiently, removing tedious burdens and allowing them to focus more on science. Commissioner Marty Makary and Chief AI Officer Jeremy Walsh emphasized that these initiatives are crucial for rapidly advancing regulatory science and delivering treatments to patients faster. The United States — Food and Drug Administration's Office of Digital Transformation has continuously improved Elsa since its initial launch in June 2025, with the system operating in a secure Alphabet Inc. — Google Cloud Platform environment that does not train on sensitive input data.