FDA launches updated AI and consolidated data platform

The FDA has launched an updated version of its internal AI tool, Elsa 4.0, integrated with a consolidated data platform called Harmonized AI & Lifecycle Operations for Data (HALO). The update enables FDA staff to query data and build workflows more efficiently.
The FDA announced the launch of Elsa 4.0, an updated version of its internal AI tool. Elsa 4.0 is integrated with the Harmonized AI & Lifecycle Operations for Data (HALO) platform, enabling faster search capabilities. The tool runs on Google Cloud Platform and has a FedRAMP High secure designation. Elsa 4.0 features custom agentic AI, document generation, data analysis, and voice-to-text functions. The FDA initially deployed Elsa in June 2025 to hasten the scientific review process. The agency has been modernizing its IT infrastructure, consolidating duplicative systems and increasing employee use of generative AI to over 80%.
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