United StatesPublic sector2025 – ongoingU.S. Food and Drug Administration (FDA)
Elsa agency-wide generative AI tool
FDA launches Elsa for staff to summarise adverse events and compare labels, with no results published
Problem
FDA reviewers and inspectors handle large volumes of documents such as adverse event reports, labels and clinical protocols.
Approach
On 2 June 2025 the agency announced Elsa, a large language model tool for reading, writing and summarising. FDA lists uses such as summarising adverse events, speeding label comparisons and clinical protocol reviews, and says the models do not train on data submitted by industry.
Results
No figures published
Takeaway
FDA introduced Elsa for document-heavy review work ahead of schedule and under budget, according to its commissioner. The agency did not publish time-saving or accuracy figures.
Categories
- Size
- Large enterprise
- Industry
- Public sector
- Business function
- Internal work and knowledge managementProduction and quality
- Innovation type
- Process innovation
- AI technology
- Generative AI
- Adoption
- Vendor solution
- Evidence
- Company's own claim
Sources
Source summaries
FDA describes Elsa and the tasks staff use it for. The agency gave only qualitative assessments of the pilot and rollout.
Full details are in the original sources.
