FDA rolls out AI tool agency-wide, weeks ahead of schedule

The Food and Drug Administration rolled out its agency-wide AI tool on Monday, weeks ahead of schedule. The public announcement provides the most detailed look yet at the technology and how it may be used.

The public announcement follows a STAT report earlier in the day indicating that the FDA was going to roll out the tool Tuesday, based on a draft press release STAT obtained.

Commissioner Marty Makary has hailed the potential of the AI at the FDA, saying it could save employees time and ultimately speed up regulatory reviews. In an internal message Monday viewed by STAT, Makary told employees they could use the AI tool, called Elsa, to “expedite clinical protocol review and reduce the overall time to complete scientific review.”