FDA Launches Elsa 4.0 and Folds More Than 40 Data Systems Into HALO Platform

The U.S. Food and Drug Administration on Wednesday launched Elsa 4.0, a new version of its internal AI tool, and said it has merged more than 40 separate application and submission data systems into a single platform called HALO, according to an FDA news release.

The agency said the upgrade is available to all FDA staff, "from scientific reviewers to investigators." HALO, short for Harmonized AI & Lifecycle Operations for Data, pulls together data sources, systems and portals from across all FDA centers. The agency said it has begun connecting HALO to Elsa so that staff can query data and build workflows without uploading documents into each chat.

What changes in Elsa 4.0

The FDA listed eight additions or improvements in the new version:

• custom agents;
• document generation;
• quantitative data analysis and visualization, including charts and graphs;
• web search through a secure web access feature;
• voice-to-text dictation;
• conversion of scanned documents and images into searchable text (OCR);
• more flexible chat capabilities;
• optimized search for key information in large document repositories.

Jeremy Walsh, the agency's chief AI officer, described the shift in the release: "Previously, FDA staff would bring data to Elsa. Now, Elsa sits on top of our data." He said the tool will soon become the main entry point into the agency's systems and data.

Commissioner Marty Makary said in the release that "Removing tedious burdens for staff enables them to focus more on science and makes their work streams more efficient and enjoyable."

Safeguards the agency described

The FDA said Elsa is built within a FedRAMP High secure Google Cloud Platform environment and "does not train on input data nor any data submitted by regulated industry." Its enhanced search can draw on refreshed secure web data, but the agency said the tool is not connected to the internet. The release also said FDA staff are involved at every stage of the work process in Elsa, with human subject matter experts verifying inputs, analytic processes and how outputs are used.

The agency first launched Elsa 1.0 in June 2025. Since then, according to the release, its Office of Digital Transformation has rolled out a series of improvements and worked with reviewers on new uses intended to streamline agency operations.

Wider modernization push

Nextgov/FCW reported that the release is part of a broader IT modernization effort at the agency, including consolidating duplicate systems and software licenses and reinvesting the savings in new technologies and hiring of as many as 3,000 new scientists. The outlet also reported that the agency has scaled employee use of generative AI from 1% in early 2025 to more than 80%, and that FDA has recently used AI in a pilot of real-time clinical trials that feeds trial data directly to agency staff.

For companies that file with the agency, the practical change is on the FDA's side of the review: the same application and submission records that sponsors send in are now consolidated in HALO, and Elsa is being connected to them. The release did not describe any change to submission requirements for sponsors, and did not say when the HALO and Elsa integration will be complete.

The FDA did not disclose the cost of the Elsa 4.0 upgrade or the HALO consolidation.