Feed: Engadget is a web magazine with obsessive daily coverage of everything new in gadgets and consumer electronics
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Title: The FDA rolls out its own AI to speed up clinical reviews and
scientific evaluations

Date: Tue, 03 Jun 2025 12:00:52 +0000
Link: https://www.engadget.com/ai/the-fda-rolls-out...

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 ΓÇö yes, weirdly like the snow queen from Frozen ΓÇö completed a "very
successful pilot program with FDAΓÇÖs 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."

This article originally appeared on Engadget at
https://www.engadget.com/ai/the-fda-rolls-out...
reviews-and-scientific-evaluations-120052323.html?src=rss

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