FDA Unveils Cutting-Edge AI Tool to Enhance Drug Review Processes

The U.S. Food and Drug Administration (FDA) launched Elsa, a generative AI tool aimed at modernizing its operations, allowing employees to work more efficiently. Marking a significant move into AI, Elsa facilitates quick searches and summaries of internal documents while safeguarding sensitive data, as it doesn’t utilize proprietary information from regulated industries. Developed in a secure GovCloud environment, the tool reduces the time spent on repetitive tasks, enhancing the review process for clinical protocols and scientific evaluations. FDA Commissioner Dr. Marty Makary noted the project was completed ahead of schedule and under budget, thanks to collaborative efforts among internal teams. As Elsa is utilized, its capabilities will be expanded based on employee feedback, focusing on usability and compliance with FDA policies. This launch is seen as the beginning of a broader strategy to fully integrate AI into FDA workflows, led by Chief AI Officer Jeremy Walsh and Senior Officer Sridhar Mantha.

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