The FDA has announced the launch of Elsa, “a generative artificial intelligence (AI) tool designed to help employees—from scientific reviewers to investigators—work more efficiently.”
FDA Commissioner Marty Makary touted a “very successful pilot program with FDA’s scientific reviewers” surrounding Elsa. The tool was “built within a high-security GovCloud environment” and “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 agency says it is “already using Elsa to accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets.” It is designed to “assist with reading, writing, and summarizing. It can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications.”
FDA also has “plans to integrate more AI in different processes, such as data processing and generative-AI functions to further support the FDA’s mission.”
HPN previously reported on the FDA’s drive to push AI across all of its centers by the end of June, as well as reactions around the industry to the technology.
Matt MacKenzie | Associate Editor
Matt is Associate Editor for Healthcare Purchasing News.
