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FDA to Expand Use of AI in Scientific Reviews

The use of artificial intelligence (AI) tools is rapidly gaining traction throughout industries around the world. Now, the U.S. Food and Drug Administration (FDA) is stepping up to leverage the potential benefits of AI.

In a press release, the FDA announced the formal launch of Elsa, a generative AI tool, intended to help FDA employees “work more efficiently.” It says that Elsa will offer agency scientific reviewers and investigators tools that can help accelerate clinical protocol reviews and also shorten the timeline for the execution of scientific evaluations.

The official launch of Elsa follows a pilot program conducted by the FDA’s scientific reviewers. The FDA says that it has plans to expand the use of Elsa further as the tool matures, integrating it into additional agency processes, such as data processing.

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The FDA’s press release announcing the launch of Elsa is available at https://www.fda.gov/news-events/press-announcements/fda-launches-agency-wide-ai-tool-optimize-performance-american-people. This link also provides access to a brief video featuring FDA Commissioner Marty Makary speaking about the official launch of this AI tool.

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