The FDA rolls out its own AI to speed up clinical reviews and scientific evaluations

The FDA has launched the generative AI tool, Elsa, agency-wide to help its employees with everything from clinical reviews to investigations. Sure, we’re living in a time of widespread disinformation and pushbacks against science, but why not rush things through with AI?

Elsa — yes, weirdly like the snow queen from Frozen — completed a “very successful pilot program with FDA’s scientific reviewers.” According to the FDA, the AI tool can help with reading, writing and summarizing everything from adverse events to assessments. Elsa can also do label comparisons and generate code. It’s already being used to speed up clinical protocol reviews and scientific evaluations, along with finding “high-priority inspection targets.”

Elsa should be a secure platform, the FDA states. It’s not clear how exactly the agency trained Elsa, but the FDA claims it’s not through “data submitted by regulated industry.” The information exists in Amazon Web Services’ GovCloud that, again, should keep all information internal.

The FDA calls Elsa the first step in its AI journey. “Today marks the dawn of the AI era at the FDA with the release of Elsa, AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee,” said FDA Chief AI Officer Jeremy Walsh. “As we learn how employees are using the tool, our development team will be able to add capabilities and grow with the needs of employees and the agency.”

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