The U.S. Food and Drug Administration said on Monday that it had launched a generative AI tool, Elsa, aimed at improving efficiency across its operations, including scientific reviews.
“Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers,” said FDA Commissioner Marty Makary.
The agency said it is already using Elsa to expedite clinical protocol reviews, shorten the time needed for scientific evaluations, and pinpoint high-priority inspection targets.
Once the FDA receives an application for a potential drug approval, it has six to 10 months to make a decision.
Elsa assists with reading, writing, and summarizing tasks. It can summarize adverse events to support safety profile assessments of drugs and rapidly compare packaging inserts.
“Elsa offers a secure platform for FDA employees to access internal documents while ensuring all information remains within the agency. The models do not train on data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff,” the FDA said.
In May, the regulator said it would fully integrate AI by June 30, following an experimental run.
—Puyaan Singh, Reuters
Login to add comment
Other posts in this group
Almost every article you’re going to read about Apple’s just-announced iOS 26 operating system f
An inspiring conversation with Jay Graber, CEO of Bluesky
Major food wholesaler United Natural Foods (UNFI) announced Monday that it experienced “unauthorized
“At long last, Apple has finally entered the AI race.”
That was the first line i
Waymo vehicles, the self-driving taxis from Google parent company Alphabet, have emerged as a literal flashpoint
For those who’ve been in the situation where we unlock our phone and start futzing around on our home screen, only to find ourselves looking up at the clock an hour later with a sense of shame and
As the director of commercial engagement for the Defense Innovation Unit (DIU), a Department of Defense (DOD) organization that funds startups developing cutting-edge weapons technology for the mi
