The U.S. Food and Drug Administration (FDA) has unveiled a major expansion of its artificial intelligence strategy, rolling out a significantly upgraded version of its internal AI platform, Elsa 4.0.
Available agency-wide, Elsa 4.0 is designed to support FDA employees ranging from scientific reviewers to investigators. Alongside the upgrade, the FDA launched HALO (Harmonized AI & Lifecycle Operations for Data), a platform that consolidates more than 40 application and submission data sources, systems, and portals across the agency.
The agency has begun integrating HALO with Elsa to enable staff to query data and build workflows without manually uploading documents. Officials said the move will deepen AI deployment across FDA operations.
“Elsa’s new capabilities once again position FDA as a leader in deploying AI tools that empower staff. Removing tedious burdens for staff enables them to focus more on science and make their workflows more efficient and enjoyable. We have some of the best scientists in the world and we need to take good care of them,” said FDA Commissioner Marty Makary, M.D., M.P.H.
“With the consolidation of our application and submission data sources, systems and portals into HALO and the improvements in Elsa’s capabilities, Elsa will soon become the main entrée into the FDA’s systems and data. Previously, FDA staff would bring data to Elsa. Now, Elsa sits on top of our data,” said Jeremy Walsh, FDA Chief AI Officer.
Since its initial launch in June 2025, Elsa has expanded to include custom agents, document generation, quantitative analysis, secure web search, optical character recognition (OCR), and advanced search capabilities.
Built within a FedRAMP High-authorized Google Cloud environment, the platform does not train on sensitive regulatory or industry-submitted data, with FDA experts validating all AI-driven outputs.