The U.S. Food and Drug Administration announced new steps to modernize its operations, including the rollout of an upgraded artificial intelligence system and the consolidation of agency data into a single platform.
The agency said it has launched Elsa 4.0, the latest version of its internal AI tool, which is now available to staff across the organization, from scientific reviewers to investigators. Officials said the update is designed to streamline workflows and reduce administrative burdens.
At the same time, the FDA has combined more than 40 separate applications and submission systems into a unified platform known as HALO, short for Harmonized AI & Lifecycle Operations for Data. The integration is intended to allow employees to access and analyze information more efficiently without manually transferring documents between systems.
“Elsa’s new capabilities once again position FDA as a leader in deploying AI tools that empower staff,” FDA Commissioner Marty Makary, M.D., M.P.H., said in a news 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.”
Officials said the agency is working to integrate Elsa with the HALO platform so staff can query data and build workflows directly within the system. The consolidation is expected to expand the use of AI across agency operations.
“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,” said Chief AI Officer Jeremy Walsh. “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.”
The agency’s Office of Digital Transformation has continued to refine the system since the initial launch of Elsa 1.0 in June 2025, which officials said was completed ahead of schedule and under budget.
New features in Elsa 4.0 include customizable agents, document generation, data analysis and visualization tools, secure web search capabilities, voice-to-text dictation, and the ability to convert scanned documents into searchable text. The system also offers improved chat functions and enhanced search tools for large document collections.
The FDA said Elsa operates within a secure, high-level cloud environment and does not train on sensitive input data or information submitted by regulated industries. Human experts remain involved in all stages of the AI process to review inputs, analysis, and outputs, the agency said.
