FDA Expands AI Capabilities and Completes Data Platform Consolidation

The U.S. Food and Drug Administration (FDA) is taking a major step to modernize the agency with Elsa 4.0, a significant upgrade to its internal artificial intelligence (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 FDA staff can query data and build workflows without manually uploading documents within each chat. The HALO consolidation is expected to enable more penetrating deployment of AI capabilities within 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,” FDA Chief AI Officer Jeremy Walsh stated. “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 FDA’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’s new capabilities once again position FDA as a leader in deploying AI tools that empower staff,” FDA Commissioner Marty Makary, M.D., said. “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.”

Elsa is built within a FedRAMP High secure Google Cloud Platform (GCP) environment and does not train on input data or any data submitted by regulated industry, thereby 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.