FDA: Launch of “Elsa” AI Tool
The U.S. Food and Drug Administration (FDA) has launched Elsa, a generative AI tool aimed at enhancing the productivity of its employees, from scientists to investigators.
Key Highlights:
- Accelerated Rollout:
- Launched ahead of the June 30 target
- Delivered under budget, thanks to cross-agency collaboration
- Secure & Private:
- Built within a high-security GovCloud
- Does not train on data from regulated industries
- Keeps all information internal to the FDA
- Early Impact:
- Speeds up clinical protocol reviews and scientific evaluations
- Helps identify top inspection priorities
- Functional Capabilities:
- Summarizes adverse events for safety reviews
- Performs label comparisons
- Generates code for nonclinical database development
- Future Plans:
- Elsa is the first step in a broader AI strategy
- More AI tools to be integrated into FDA operations over time, such as data processing and generative-AI functions
Source:
FDA: Press Announcements
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