FDA's Elsa AI Cuts Days of Work Down to Minutes

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FDA Launches Elsa: AI That Cuts Days of Work Down to Minutes

Written by Aaron S.,

Editor-In-Chief

Last Updated: June 03, 2025

Key Takeaways

The FDA launched Elsa, an AI tool that speeds up routine tasks like safety reviews and inspections across the agency;
Elsa runs within the FDA’s GovCloud system and avoids using any company-submitted data;
The FDA plans to expand Elsa’s role by adding features like data automation and more generative AI applications.

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FDA Launches Elsa: AI That Cuts Days of Work Down to Minutes

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On June 3, the US Food and Drug Administration (FDA) introduced Elsa, a new internal artificial intelligence (AI) platform, to improve how the agency manages its daily work.

Tasks that once took several days can be completed in minutes, including safety report reviews, comparing drug labels, writing code for internal databases, and flagging inspection sites that may need extra attention.

In a video announcement, Commissioner Marty Makary noted that Elsa became available across the agency ahead of schedule and stayed within budget.

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The system operates within the FDA’s GovCloud environment, which ensures that all activity remains within the agency. None of the AI tools are trained on information submitted by companies, which helps prevent potential privacy concerns.

Elsa is already being used to automate some repetitive tasks so that FDA staff can focus on tasks that require human review. By handling the more routine steps, the AI system helps staff work faster without changing the agency’s review standards.

The FDA stated that it will continue to expand Elsa's capabilities. Future updates will include more advanced features, such as data automation and additional applications for generative AI.

Chief AI Officer Jeremy Walsh said, "AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee".

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