“Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers,” said FDA Commissioner Marty Makary.
The agency said it is already using Elsa to expedite clinical protocol reviews, shorten the time needed for scientific evaluations, and pinpoint high-priority inspection targets.
Once the FDA receives an application for a potential drug approval, it has six to 10 months to make a decision.
Elsa assists with reading, writing, and summarizing tasks. It can summarize adverse events to support safety profile assessments of drugs and rapidly compare packaging inserts.
“Elsa offers a secure platform for FDA employees to access internal documents while ensuring all information remains within the agency. The models do not train on data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff,” the FDA said.
In May, the regulator said it would fully integrate AI by June 30, following an experimental run.
