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Elsa’s Impact: Navigating Compliance in an Era of AI-Enhanced FDA Oversight

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On June 2, 2025, the U.S. Food and Drug Administration (FDA) announced the deployment of its own artificial intelligence system, “Elsa.” The large language model-powered system was scheduled for full-scale implementation across the agency by June 30, 2025. Initially piloted for FDA scientific reviewers, Elsa is intended to streamline internal processes and increase operational efficiency within the agency….
By: Husch Blackwell LLP

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