A scientific reviewer at the U.S. Food and Drug Administration once took three days to complete a task. With a new AI assistant, it now takes six minutes.
That’s just one example FDA Commissioner Marty Makary gave Monday as the agency officially launched Elsa, a generative AI platform designed to overhaul how the FDA handles internal workflows, ranging from drug safety evaluations to inspection targeting.
He said the agency-wide rollout beat its original June 30 deadline and came in under budget.
“Today, the FDA has launched a new AI tool, agency-wide, called Elsa, to modernize how the agency functions,” Makary said in a video announcement. “We met that goal ahead of schedule and under budget, thanks to the willingness and collaboration of our in-house scientific leaders across the centers.”
The commissioner said Elsa is a secure, internal artificial intelligence assistant hosted in the FDA’s GovCloud environment, according to the agency statement.
It can summarize adverse event reports, compare drug labels, generate code for nonclinical databases, and help inspectors identify high-risk sites.
“All information stays within the agency, and the AI models are not being trained on data submitted by the industry,” Makary noted.
Chief AI Officer Jeremy Walsh called Elsa’s launch “the dawn of the AI era at the FDA,” noting “AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee.”
The FDA plans to expand Elsa’s role into data automation and generative artificial intelligence as the tool matures.
Makary said Elsa marks the first of several upcoming AI initiatives as the agency works to “rapidly transform” internal operations and better serve the public.
The FDA’s rollout follows a larger push by the federal government to integrate artificial intelligence into core operations.
In April, the White House issued new guidance requiring agencies to assign AI leadership roles and craft internal policies for managing high-risk uses of AI.
As federal institutions begin to scale AI internally, private-sector leaders are envisioning how the same technologies could reshape the structure of business itself.
At the Bitcoin 2025 conference in Las Vegas, Robinhood CEO Vlad Tenev predicted a future of AI-powered solo ventures—lean, self-operating companies enabled by generative tools.
"I think you'll have more single-person companies, and you have to imagine that they'll be tokenized, and they'll trade on blockchains—just like other assets,” Tenev said.
Edited by Stacy Elliott.
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