By Fineline Cube 
The U.S. Food and Drug Administration (FDA) announced the launch of an artificial intelligence (AI) tool named “Elsa”, designed to improve work efficiency for various staff members, from scientific reviewers to researchers. This initiative represents a significant step forward in integrating AI into regulatory processes.
Elsa’s Capabilities
Elsa, powered by a large language model (LLM), can summarize adverse events to support safety assessments, accelerate label comparisons, and generate code to assist in developing databases for non-clinical applications. The technology provides FDA employees with a secure platform that ensures access to internal documents while safeguarding sensitive research and data.
Pilot Program Success
FDA Commissioner Marty Makary stated that a highly successful pilot program had previously been conducted with the agency’s scientific review teams. The tool has demonstrated its ability to streamline workflows and enhance productivity.
Future AI Integration
Elsa marks the beginning of FDA’s AI integration efforts. Moving forward, the agency plans to incorporate more AI technologies across different processes, including data processing and generative AI, to drive operational efficiency and business transformation.-Fineline Info & Tech