- The FDA has launched Elsa, a secure generative AI tool designed to boost efficiency across the agency—from scientific reviews to inspections—marking a major step in modernizing operations with AI.
- Elsa was deployed ahead of schedule and under budget, following a successful pilot, thanks to collaboration among FDA centers and strong leadership from Commissioner Marty Makary.
- Built in a secure GovCloud environment, Elsa ensures that sensitive internal data remains protected, and does not train on information submitted by regulated industries.
- Elsa is already streamlining FDA tasks, such as accelerating clinical protocol reviews, summarizing adverse events, comparing labels, and generating code—ushering in a new era of AI-driven regulatory work.
FDA Launches Elsa: A New AI Era for Regulatory Efficiency
The U.S. Food and Drug Administration (FDA) has officially launched Elsa, a generative artificial intelligence (AI) tool aimed at revolutionizing how agency employees—from scientific reviewers to field investigators—work across its vast regulatory landscape. This rollout marks a significant milestone in the FDA’s ongoing efforts to modernize operations and leverage cutting-edge technology to better serve the American public, but it brings new dangers to the equation that are unprecedented and unpredictable.
Commissioner Dr. Marty Makary praised the rapid and cost-effective development of Elsa, crediting the agency’s internal collaboration and technological leadership for launching the tool ahead of schedule and under budget. Initially tested with scientific reviewers in a pilot program, Elsa has now been scaled across the agency, demonstrating promising results in improving workflow efficiency and information processing.
Built within a high-security GovCloud environment, Elsa ensures that sensitive data—particularly submissions from regulated industries—remains protected. The AI does not train on proprietary or confidential data, aligning with the FDA’s commitment to security, data integrity, and regulatory compliance. The system provides employees with secure access to internal documentation, allowing them to retrieve, analyze, and summarize information quickly without risking data exposure.
Elsa, which is powered by a large language model, supports a broad array of tasks. It can summarize adverse event reports, compare pharmaceutical labels, and generate code to aid in the development of databases for nonclinical research. Additionally, Elsa is already being used to accelerate clinical protocol reviews, enhance scientific evaluations, and identify high-priority inspection targets—a significant improvement in the FDA’s operational efficiency.
According to Jeremy Walsh, the FDA’s Chief AI Officer, Elsa represents the official beginning of the agency’s AI transformation. “AI is no longer a distant promise but a dynamic force,” Walsh said, emphasizing the potential of AI to augment and optimize each employee’s performance. As staff begin using Elsa in real-world scenarios, its developers plan to expand its capabilities based on user feedback and evolving agency needs.
The launch of Elsa is just the first step in what the FDA envisions as a broader integration of AI technologies throughout its functions. Future plans include expanding AI applications to support data processing, generative-AI content creation, and other complex regulatory processes. The goal is to build a smarter, faster, and more adaptable FDA that can respond more effectively to public health needs.
In deploying Elsa, the FDA took an all-center approach, involving leaders and technical teams from across the agency. This unified strategy allowed the FDA to demonstrate its readiness and agility in implementing transformative digital solutions. By embracing AI like Elsa, the agency positions itself at the forefront of technology-driven governance, reinforcing its mission to protect and promote public health through innovation, precision, and speed.
Ultimately, Elsa symbolizes a new chapter in the FDA’s evolution—where artificial intelligence enhances decision-making, streamlines workflows, and helps ensure that the agency’s work continues to meet the growing demands of modern science and public safety.
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