The U.S. Food and Drug Administration (FDA) announced on Monday the launch of a generative AI tool, Elsa, designed to enhance operational efficiency, particularly in scientific reviews.
FDA Commissioner Marty Makary noted that the tool’s deployment was ahead of schedule and under budget, thanks to the collaboration of in-house experts across various centers. Elsa is already being used to streamline clinical protocol reviews, accelerate scientific evaluations, and identify high-priority inspection targets.
Once the FDA receives a drug approval application, it has a window of six to 10 months to make a decision. Elsa aids this process by assisting with tasks like reading, writing, and summarizing. It can quickly summarize adverse events for drug safety assessments and compare packaging inserts.
The tool provides a secure platform for FDA staff to access internal documents while ensuring sensitive data remains protected. “Elsa does not train on data submitted by the regulated industry, maintaining the confidentiality of research and data handled by the FDA,” the agency stated.
In May, the FDA announced its goal to fully integrate AI into its operations by June 30, following an initial trial period.
Related topics:
