The U.S. Food and Drug Administration today announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a significant upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.
The agency also consolidated more than 40 disparate application and submission data sources, systems and portals across all FDA centers into a new platform called HALO (Harmonized AI & Lifecycle Operations for Data).The agency began integrating HALO and Elsa so that FDA staff can query data and build workflows without having to manually upload documents within each chat. The HALO consolidation is expected to enable more penetrating deployment of AI capabilities within agency operations.
“Elsa’s new capabilities once again position FDA as a leader in deploying AI tools that empower staff,” said FDA Commissioner Marty Makary, M.D., M.P.H. “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.”
“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 Jeremy Walsh, Chief AI Officer. “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.”
Since launching Elsa 1.0 in June 2025, ahead of schedule and under budget, the agency's Office of Digital Transformation has continually rolled out improvements and pioneered new use cases with agency reviewers to help streamline agency operations.
New Elsa 4.0 features include:
- Custom agents
- Document generation
- Quantitative data analysis and visualization, including chart/graph creation
- Web search through a secure web access feature
- Voice-to-text dictation
- Conversion of scanned documents and images into searchable text (OCR)
- Enhanced flexibility in chat capabilities
- Optimized search for finding key information in large document repositories
Elsa is built within a FedRAMP High secure Google Cloud Platform (GCP) environment – and does not train on input data nor any data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff. Its enhanced search capability allows it to access refreshed secure web data in responses, but it is not connected to the internet. FDA staff are involved at every stage of the AI work process in Elsa, so that human subject matter experts verify all inputs, analytic processes, and output implementation.
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