The US Food and Drug Administration (FDA) has launched a new artificial intelligence (AI) tool called Elsa, which is designed to assist with clinical protocol reviews and other scientific tasks. Initially planned for June 30, the agency decided to roll out the tool early, ahead of schedule, following successful testing in a pilot program.
According to FDA Commissioner Marty Makary, Elsa will expedite clinical protocol reviews, reducing the overall time to complete scientific reviews from two to three days to just six minutes. The AI tool can also summarize adverse events for safety profile assessments and compare labels for expedited decision-making.
Makary emphasized that all information in Elsa remains within the agency, and the AI models are not trained on external data. He highlighted that the launch marks the beginning of the FDA’s overall AI journey, with plans to integrate more AI capabilities into different processes.
To ensure a smooth transition, training sessions have been set up for staff to learn how to use Elsa in their daily work. Initial feedback from reviewers suggests that the tool is accurately answering questions.
The FDA has faced concerns over its AI capabilities, but Makary assured that Elsa’s launch was not “rushed” and that the agency is committed to using AI responsibly. With this move, the FDA aims to improve efficiency and support its mission to serve the American public.
Source: https://www.raps.org/news-and-articles/news-articles/2025/6/fda-launches-agency-wide-ai-tool-%E2%80%98elsa-ahead-of-sc