The US Food and Drug Administration (FDA) has launched a generative Artificial Intelligence (AI) tool called Elsa to help employees work more efficiently. The tool was designed by the agency’s in-house experts and is built within a high-security GovCloud environment.
Elsa is a large language model-powered AI tool that can assist with reading, writing, and summarizing tasks. It will be used to accelerate clinical protocol reviews, shorten scientific evaluation times, and identify high-priority inspection targets.
The FDA launched Elsa ahead of schedule, using an all-center approach that involved collaboration between leaders and technologists across the agency. The introduction of Elsa is part of the FDA’s overall AI journey, with plans to integrate more AI in different processes as the tool matures.
Elsa does not train on data submitted by regulated industry, ensuring that sensitive research and data handled by FDA staff remain secure. The tool will also be used to generate code for nonclinical applications and support safety profile assessments.
The FDA’s Commissioner Marty Makary said: “Today marks the dawn of the AI era at the FDA with the release of Elsa.” The agency plans to continue to evolve its operations through the use of AI, prioritizing efficiency and responsibility.
Source: https://www.fda.gov/news-events/press-announcements/fda-launches-agency-wide-ai-tool-optimize-performance-american-people