WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration announced the launch of Elsa, a generative Artificial Intelligence or AI tool, with a view to modernize agency functions to optimize performance.
Elsa, which is built within a high-security GovCloud environment, offers a secure platform for the FDA employees to access internal documents while ensuring all information remains within the agency. It helps scientists and investigators to improve operational efficiency by spending less time on tedious, repetitive tasks that often slow down the review process.
The FDA said it launched Elsa ahead of schedule using an all-center approach, prioritizing efficiency and responsibility. As Elsa, its initial step in the overall AI journey, matures, the agency plans to integrate more AI in different processes, including data processing and generative-AI functions to further support its mission.
The new generative AI tool is a large language model-powered AI tool designed to assist with reading, writing, and summarizing. Elsa can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications.
The FDA noted that the models do not train on data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff.
The agency is already using Elsa to accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets.
The FDA in early May had announced that an AI-assisted scientific review pilot would be rolled out by June 30, and that FDA Commissioner Martin Makary had directed all FDA centers to begin deployment immediately, with the goal of full integration by the end of June.
Makary now said, 'Following a very successful pilot program with FDA's scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30. Today's rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.'
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