WASHINGTON, D.C. — The U.S. Food and Drug Administration has launched Elsa 4.0, an upgraded version of its internal artificial intelligence platform, and consolidated more than 40 agency data systems into a new platform called HALO as part of a broader modernization initiative.
The FDA said the rollout is intended to streamline internal operations by allowing staff, including scientific reviewers and investigators, to access and analyze data more efficiently. The agency also has begun integrating Elsa with HALO, short for Harmonized AI & Lifecycle Operations for Data, so employees can query agency data and build workflows without manually uploading documents into chat systems.
Marty Makary said the upgrades are designed to reduce administrative burdens and improve efficiency for agency scientists and reviewers.
“Removing tedious burdens for staff enables them to focus more on science and makes their work streams more efficient and enjoyable,” Makary said. “We have some of the best scientists in the world and we need to take good care of them.”
According to the FDA, Elsa 4.0 introduces several new capabilities, including custom AI agents, document generation, quantitative data analysis, chart and graph creation, voice-to-text dictation, optical character recognition for scanned documents, and enhanced search functions for large document repositories. The platform also includes secure web search functionality.
Jeremy Walsh said the integration of Elsa and HALO will allow the AI system to operate directly on top of agency data systems rather than requiring staff to upload information manually.
“Previously, FDA staff would bring data to Elsa. Now, Elsa sits on top of our data,” Walsh said. “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 FDA said Elsa operates within a FedRAMP High secure Google Cloud environment and does not train on agency input data or submissions from regulated companies. The agency added that the platform is not connected directly to the internet and that FDA staff remain responsible for reviewing and validating AI-generated outputs.
The FDA first launched Elsa 1.0 in June 2025. Since then, the agency’s Office of Digital Transformation has expanded the tool’s capabilities and introduced additional use cases aimed at streamlining regulatory workflows.
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