The FDA on June 2 launched a generative artificial intelligence tool agencywide to improve internal workflows and staff efficiency.
Four things to know.
1. The AI tool, Elsa, is currently being used to speed up the review of clinical trial protocols, reduce the time needed to analyze scientific data and identify the agency’s most urgent inspection priorities.
2. Elsa can quickly summarize adverse events to help assess product safety, perform quick label comparisons and generate code for creating internal FDA databases.
“As we learn how employees are using the tool, our development team will be able to add capabilities and grow with the needs of employees and the agency,” FDA Chief AI Officer Jeremy Walsh said in a June 2 news release.
3. The tool operates within GovCloud, a secure Cloud platform used by federal agencies to manage sensitive data. It is powered by a large language model but does not train on any data submitted by drug manufacturers, device makers or other regulated industry entities.
4. The rollout comes after a successful pilot and precedes a June 30 deadline set by FDA Commissioner Martin Makary, MD, to implement the tool agencywide.
Learn more here.
