The tool is being used in scientific evaluations and clinical reviews, according to the agency.
The Food and Drug Administration on June 2 launched a new artificial intelligence (AI) tool.
FDA officials said Elsa, the tool, will help employees “work more efficiently.”
The agency is utilizing Elsa to speed up clinical protocol reviews and scientific evaluations, as well as to identify targets for inspections.
FDA officials described Elsa as a “large language model–powered AI tool designed to assist with reading, writing, and summarizing.” They said it can summarize adverse events to help with safety profile assessments, compare labels faster than humans, and generate code to help develop databases.
“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,” FDA Chief AI Officer Jeremy Walsh said in a statement.
AI refers to computer systems that perform complex tasks typically performed by humans.
Dr. Marty Makary, the FDA’s commissioner, said in May that the FDA would immediately start using AI and fully integrate it by the end of June.
“Following a very successful pilot program with FDA’s scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30,” Makary said on Monday. “Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.”
Health Secretary Robert F. Kennedy Jr., who leads the Department of Health and Human Services (HHS), the FDA’s parent agency, cheered the development, calling it “a revolution in public health” in a post on social media platform X.
The FDA recently fired thousands of employees. HHS officials had said they would cut about 3,500 full-time workers but ended up terminating about 2,500 workers, according to a Senate Democrat report.
Makary told a congressional panel during a recent appearance that no scientific reviewers were fired, although some research scientists were among those terminated.
