The FDA has embraced artificial intelligence by launching a new AI tool named ‘Elsa.’ Built on Amazon Web Services’ GovCloud, Elsa securely handles sensitive government data without using proprietary manufacturer information. The tool was launched ahead of schedule and under budget, showcasing strong collaboration within the FDA. Elsa is already in use and is expected to be fully integrated into FDA workflows by June 30. This initiative demonstrates the FDA’s commitment to adopting advanced technologies, improving efficiency, and strengthening public health protections through smarter, faster regulatory decision-making. This development highlights the potential for AI in enhancing clinical trial design and regulatory processes, paving the way for more streamlined and effective healthcare advancements.
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