FDA Launches Elsa 4.0 and HALO to Expand Agencywide AI Operations

The U.S. Food and Drug Administration (FDA) launched Elsa 4.0, the latest version of its internal artificial intelligence assistant, alongside a new unified data platform called HALO, according to a 05/06 announcement from the agency.

The platform consolidation combines more than 40 FDA application, submission, and operational systems into HALO, short for Harmonized AI and Lifecycle Operations for Data. FDA said it has begun integrating HALO directly with Elsa so employees can query internal systems and build workflows without manually uploading documents into chats.

The agency said the rollout is part of a broader modernization effort focused on regulatory operations, scientific review workflows, and internal productivity. FDA Commissioner Marty Makary, MD, MPH, said the new capabilities are intended to reduce administrative burdens for agency staff and allow them to focus more on scientific work.

Jeremy Walsh, Chief AI Officer at FDA, said Elsa would increasingly serve as the primary interface into FDA systems and data infrastructure. Walsh said FDA staff previously brought information into Elsa manually, but the system is now being positioned directly on top of agency data layers.