Meet ELSA: USFDA Launches Agency-Wide AI Tool to Optimize Performance

What if the agonizing wait for drug approvals could be slashed from days to minutes?

Imagine a future where breakthrough therapies reach patients faster — and safer — thanks to the power of artificial intelligence. That future just became reality.

On May 20, 2025, the U.S. Food and Drug Administration (FDA) quietly ignited a seismic shift in how medicines and medical devices get reviewed and approved.

FDA Commissioner Dr. Marty Makary's announcement marked a milestone in government-led AI innovation by launching "Elsa" today (02 June 2025), a generative Artificial Intelligence (AI) tool designed to help employees, from scientific reviewers to investigators, work more efficiently.

Elsa (an acronym for the tool’s full name, not publicly disclosed) is a large language model–powered AI tool designed to assist with reading, writing, and summarizing.

Why Was ELSA Created?

The FDA processes thousands of clinical protocols, safety reports, and drug labeling updates each year. These vital documents are scrutinized by scientific reviewers, but even with the sharpest minds at the table, the system has been bottlenecked by sheer volume.

Enter ELSA, trained to:

• Analyze clinical protocols

• Identify high-priority inspection targets

• Summarize adverse event reports to support safety profile assessments

• Compare drug labels across products

• Generate code for building nonclinical databases

Elsa isn’t just any AI—it’s custom-built for the FDA’s unique needs and operates within a high-security GovCloud environment. All data stays within the agency, and the AI models are never trained on sensitive industry submissions. This means patient data and proprietary research remain confidential and protected

USFDA Commissioner Marty Makary mentioned in the press briefing that one FDA scientific reviewer shared that “What took one reviewer two to three days now takes six minutes”, thanks to Elsa. Imagine the ripple effects: less time on repetitive work means more focus on complex, high-stakes scientific questions

As Elsa continues to evolve, the FDA intends to expand the use of AI across additional processes, including advanced data processing and generative AI capabilities, to further strengthen its mission.

By prioritizing both efficiency and accountability, the FDA successfully rolled out Elsa ahead of schedule through a collaborative, agency-wide effort.

The FDA’s Elsa tool isn’t just a technological upgrade—it’s a paradigm shift in how the agency serves the public. By automating tedious tasks and accelerating critical reviews, Elsa empowers scientists to focus on what matters most: protecting and improving patient lives.

Read the official announcement and learn more about this groundbreaking initiative in the FDA’s press release.

Watch the full video of the press briefing on YouTube.

Got thoughts or questions? Share them in the comments below — the AI era of medicine is here, and your voice matters.