On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and leverages AI capabilities to better serve the American people.” While Elsa may add efficiencies to FDA’s review processes, it also raises a number of questions for regulated industry.
What Is Elsa and How Will It Be Used?
According to FDA, Elsa is…
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https://www.morganlewis.com/blogs/asprescribed/2025/06/fdas-ai-assisted-review-the-next-stage-of-regulated-product-evaluation
