The Food and Drug Administration has launched Elsa 4.0, the latest version of its internal artificial intelligence platform, and consolidated more than 40 agency application and submission systems into a new data platform called HALO.
The agency said Wednesday the modernization effort is intended to expand AI integration across FDA operations and improve how staff access and analyze regulatory data.
“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 Jeremy Walsh, FDA chief AI officer.
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What New Features Were Added to Elsa 4.0?
New capabilities in Elsa 4.0 include custom AI agents, document generation, quantitative data analysis and visualization, voice-to-text dictation, optical character recognition and enhanced search functions for large document repositories.
Elsa operates within a Google Cloud Platform environment that has achieved high authorization under the Federal Risk and Authorization Management Program and does not train on agency- or regulated-industry data.
What Is FDA’s HALO Platform?
HALO, short for Harmonized AI & Lifecycle Operations for Data, unifies application, submission and operational data from FDA centers into a single platform.
By syncing HALO and Elsa, the FDA is streamlining operations, enabling personnel to run data queries and build workflows without manual file uploads.
“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,” said Walsh.
How Does Elsa 4.0 Fit Into FDA’s Broader AI Modernization Effort?
The launch and integration expand FDA’s effort to deploy generative AI tools agencywide following a scientific review pilot completed in 2025.
Last year, FDA Commissioner Marty Makary directed all agency centers to implement AI capabilities and transition to a common generative AI platform integrated with internal data systems.
“There have been years of talk about AI capabilities in frameworks, conferences and panels but we cannot afford to keep talking,” Makary said at the time. “The opportunity to reduce tasks that once took days to just minutes is too important to delay.”
Elsa 1.0 was launched in June 2025 ahead of schedule and under budget. The FDA Office of Digital Transformation has continued to expand use cases and platform functionality since the initial rollout.
