The U.S. Food and Drug Administration (FDA) announced the launch of a groundbreaking new generative AI technology called Elsa on Monday. This innovative tool is designed to modernize agency functions and leverage AI capabilities to enhance efficiency and better serve the American people.
Elsa, which is powered by a large language model, has a wide range of applications within the FDA. It can help summarize adverse events to support safety profile assessments, facilitate faster label comparisons, and generate code to assist in the development of databases for nonclinical applications. The tool has already been utilized to streamline clinical protocol reviews, reduce the time required for scientific evaluations, and identify high-priority inspection targets.
Moving forward, Elsa will play a central role in the FDA’s AI journey by improving operational efficiency across the administration. As the tool is further refined, it will be integrated with additional use cases such as data processing. Developed and built within a high-security GovCloud environment, Elsa provides a secure platform for FDA employees to access internal documents while maintaining the confidentiality of sensitive information.
It is important to note that the models powering Elsa are not trained on data submitted by regulated industry, ensuring that the sensitive research and data handled by FDA staff are safeguarded. This new AI tool represents a significant step forward in the FDA’s commitment to harnessing the power of artificial intelligence to enhance its operations and better serve the public.
In a statement, FDA Commissioner Dr. Marty Makary expressed his satisfaction with the successful rollout of Elsa, which was completed ahead of schedule and under budget. Chief AI Officer Jeremy Walsh highlighted the transformative potential of AI at the FDA, stating that Elsa marks the beginning of a new era where AI serves as a dynamic force that optimizes the performance of every employee.
The launch of Elsa aligns with the broader trend of government agencies embracing AI technologies to improve efficiency and efficacy. With the recent executive order emphasizing the aggressive adoption of AI across federal agencies, the FDA is at the forefront of this technological revolution.
As the FDA continues to integrate Elsa into its operations and explore new applications for AI, the agency is poised to leverage cutting-edge technology to enhance its regulatory functions and better protect public health.
