The FDA is piloting one-day inspectional assessments and expanding its internal AI platform, Elsa, as part of a broader agency modernization effort.
The moves come as the agency works to “do more with less” after workforce cuts last year strained inspectional capacity and slowed some regulatory timelines. The upgraded AI tool, Elsa 4.0, is the latest iteration of a platform the FDA first launched agencywide in June 2025 and has since expanded to include agentic capabilities used by more than 70% of agency staff.
Here are five notes from May 6 agency updates:
- The agency launched a pilot program in April to conduct one-day inspectional assessments across multiple inspectorates, including human and animal foods, biologics, medical products and clinical research programs.
- As of late April, the agency had completed approximately 46 one-day assessments. Most resulted in No Action Indicated outcomes, though some assessments extended beyond one day when investigators identified significant observations.
- FDA Commissioner Marty Makary, MD, said the shorter inspections are intended to expand surveillance coverage and allow the agency to focus inspectional resources on higher-risk facilities.
- Elsa 4.0’s new features include custom agents, document generation, quantitative data analysis, OCR functionality and secure web search capabilities.
- The agency consolidated more than 40 application and submission data systems into a new platform called HALO, which it said will support broader AI integration across regulatory workflows and data operations.
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