FDA launches an AI tool to be more productive

There's a fresh face in the FDA's digital halls — and no, she doesn't need a badge. Her name's Elsa, and she's the agency's boldest bet yet on generative AI. Designed to help FDA employees — from sharp-eyed scientists to on-the-ground inspectors — this AI assistant isn't just another gadget. She's a workhorse, quietly reshaping how the agency serves the American public.

"AI is no longer a distant promise but a dynamic force," said Jeremy Walsh, the FDA's Chief AI Officer. And with Elsa now live, that force is already hard at work.

How does it work?

Elsa isn't some plug-and-play chatbot. She's a high-powered large language model built into the FDA's secure GovCloud ecosystem. That means:

• Internal documents stay inside the agency — no peeking from the outside world.
• She doesn't learn from sensitive industry-submitted data, keeping trade secrets safe.
• She works behind the scenes, assisting staff in summarizing adverse events, speeding up label comparisons, and even generating code to help build databases.

In plain English? Elsa reads, writes, and distills complex info in seconds — so FDA folks can focus on decisions, not digging through data.

Why does it matter?

The FDA has never been short on mission. But time and resources? That's another story. Enter Elsa, who's already helping:

• Cut down clinical protocol review times
• Speed up scientific evaluations
• Flag high-priority inspection targets with laser focus

And she's only getting smarter. As employees use her in real-world scenarios, the tech team plans to tailor Elsa's skills to better suit daily needs. Like a reliable coworker who actually listens, Elsa evolves with feedback.

"Today marks the dawn of the AI era at the FDA," Walsh said. That's not just poetic flair — it's a seismic shift in how the agency operates.

The context

The rollout didn't happen overnight. After a pilot with scientific reviewers hit it out of the park, FDA Commissioner Dr. Marty Makary set an "aggressive timeline" to expand Elsa agency-wide by June 30. They beat the deadline. And came in under budget.

That's not just a tech win — it's a cultural one. All centers chipped in, from leadership to lab techs, proving that collaboration — not just code — is what drives innovation in government.

The bigger picture? Elsa is just the first step. The FDA is eyeing more AI-powered tools to handle complex processes, crunch data faster, and make decisions sharper. In an age where trust, transparency, and time are everything, tools like Elsa could change the game.

As Makary put it, "Thanks to the collaboration of our in-house experts... today's rollout is ahead of schedule and under budget."

When was the last time anyone said that about a federal tech project?