FDA Rolls Out Latest Version of Elsa AI and a Data Platform

The latest version of the Food and Drug Administration’s (FDA) internal artificial intelligence (AI) tool, Elsa, is now available to all agency staff for a multitude of functions, the FDA announced Wednesday.

Elsa 4.0 is a “significant upgrade” to the AI tool first launched in June 2025, the agency said. The new version of Elsa offers custom agents, document generation, quantitative data analysis and visualization, secure web searches, voice-to-text dictation, conversion of scanned documents and images into searchable text, more flexibility in chat capabilities, and better search capability for large document repositories.

FDA also announced the launch of a new data platform dubbed the Harmonized AI and Lifecycle Operations for Data, or HALO. The platform consolidates more than 40 disparate data sources, systems, and portals across FDA centers.

The agency is integrating Elsa and HALO so that FDA employees can query data and build workflows without needing to upload documents within each chat, the agency said.

“Integrating AI into our workflows is an urgent priority that will allow us to rapidly advance regulatory science and deliver more cures and meaningful treatments to patients faster,” said FDA Chief AI Officer Jeremy Walsh.

“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,” Walsh added.

Elsa first rolled out last year. The tool came in under budget and ahead of schedule, according to the FDA. The FDA also teased HALO last year, saying it was working on a unified platform with would expand document integration and usability.

In a LinkedIn post, the FDA said HALO and Elsa 4.0 are “expected to create cost-savings efficiencies,” but did not provide details on how much it expects the technology will save.