FDA Launches AI Tool Elsa to Speed Up Scientific Reviews
The U.S. Food and Drug Administration has launched a generative artificial intelligence tool, Elsa, to improve efficiency in its operations, including scientific reviews.
FDA Commissioner Marty Makary said the rollout was ahead of schedule and under budget due to collaboration among in-house experts.
Elsa is already being used to expedite clinical protocol reviews, reduce the time required for scientific evaluations, and identify high-priority inspection targets.
The FDA typically has six to 10 months to decide on a drug approval application. Elsa supports this process by assisting with reading, writing, and summarising tasks.
The tool can summarise adverse events to help assess drug safety profiles and quickly compare packaging inserts.
Elsa provides a secure platform for FDA employees to access internal documents. The agency said the models do not train on data submitted by regulated industry, protecting sensitive research and data.
In May, the FDA announced plans to fully integrate AI by June 30, following an experimental phase.
FDA launches AI tool Elsa to improve review efficiency
Elsa helps summarise data and assess drug safety
Tool already in use for clinical protocol reviews
Source: REUTERS
