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The Food and Drug Administration announced on Wednesday that it has launched an updated version of its internal artificial intelligence tool, called Elsa, that is being integrated with a consolidated data platform to enable faster search capabilities.
Elsa 4.0 now features expanded access to disparate agency information within a new consolidated data platform, called the Harmonized AI & Lifecycle Operations for Data. By merging HALO and Elsa, staff are able to query data and build workflows with less manual updating.
Elsa 4.0 runs on Google Cloud Platform and is built within a FedRAMP High secure designation. It isn’t trained on input data or data submitted by regulated industry, in order to safeguard sensitive information handled by FDA personnel.
“Elsa’s new capabilities once again position FDA as a leader in deploying AI tools that empower staff,” FDA Commissioner Marty Makary said in a press release. “Removing tedious burdens for staff enables them to focus more on science and makes their work streams more efficient and enjoyable. We have some of the best scientists in the world and we need to take good care of them.”
The upgrades to Elsa 4.0 include custom agentic AI, document generation, data analysis and visualization functions, voice-to-text diction, web search features and conversion of scanned documents into searchable text, among other capabilities.
The FDA initially deployed Elsa in June 2025 with a core goal of hastening the scientific review and evaluation process. The agency has also recently turned to AI to run a pilot for real-time clinical drug trials that will pull a direct data feed on the trial for FDA staff to expedite analyses and clearances of devices, drugs and medications.
The FDA has been on a broad IT modernization journey in recent months, consolidating duplicative systems and software licenses, using the savings it has achieved to reinvest in the scientific community, new technologies and to onboard as many as 3,000 new scientists. The agency has also worked to scale up employee use of generative AI from just 1% in early 2025 to over 80% today.
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