FDA Launches “Generative AI Tool”

The Food and Drug Administration (FDA) has launched a “generative AI tool” to “modernize” agency functions.

“Today, the FDA launched Elsa, a generative AI tool designed to help employees—from scientific reviewers to investigators—work more efficiently. This innovative tool modernizes agency functions and leverages AI capabilities to better serve the American people,” the FDA stated.

Elsa will perform the following:

➤ Accelerate clinical protocol reviews
➤ Shorten the time needed for scientific evaluations
➤ Identify high-priority inspections targets
➤ Perform faster label comparisons
➤ Summarize adverse events to support safety profile assessments
➤ Generate code to help develop databases for nonclinical applications