The U.S. Food and Drug Administration (FDA) is undergoing a significant transformation, aggressively integrating artificial intelligence (AI) across all its centers with a target completion date of June 30, 2025. This ambitious initiative follows the success of an initial generative AI pilot program and marks a pivotal step in the agency's ongoing modernization efforts, promising enhanced efficiency and better public health services.
FDA Commissioner Martin A. Makary, MD, MPH, has championed this move, citing the pilot program's remarkable ability to reduce the time required for routine scientific review tasks. The pilot utilized generative AI tools to automate repetitive, time-consuming components of the regulatory review process, thereby freeing up scientists to concentrate on more complex and critical issues. Jinzhong Liu, Deputy Director of the Office of Drug Evaluation Sciences within the Center for Drug Evaluation and Research (CDER), noted that AI support allowed tasks previously taking days to finalize to be completed in mere minutes.
These AI tools incorporate generative AI models adept at processing vast quantities of regulatory data, synthesizing documentation, and generating summaries to aid scientific reviewers. Commissioner Makary has directed all FDA centers to immediately begin AI implementation, with each center expected to operate on a unified and secure generative AI platform integrated with the FDA’s internal systems by the end of June 2025. Following this milestone, the FDA plans to continuously refine the system by improving functionality, expanding supported tasks, and adapting the technology to the unique demands of each center.
The agency-wide rollout is being spearheaded by newly appointed leaders: Jeremy Walsh, the FDA’s first-ever Chief AI Officer, and Sridhar Mantha, Senior Advisor on AI and former CDER informatics lead. The AI system will be integrated with the FDA’s internal data platforms and customized to each center's specific requirements, all while maintaining stringent security and compliance with federal information systems standards. The FDA has emphasized that these AI tools are intended to support, not replace, human reviewers.
The implementation of AI is expected to revolutionize several key FDA functions. These include accelerating document review processes, enhancing the tracking of regulatory compliance, and providing support for scientific analysis. The agency has also launched Elsa, a generative AI tool designed to help employees work more efficiently by summarizing adverse events, performing label comparisons, and generating code for non-clinical application databases. Furthermore, the FDA envisions leveraging AI-based computational models to predict toxicity, potentially reducing the need for animal testing and expediting drug development.
This integration also signals a broader cultural shift within the agency, embracing emerging technology to meet the challenges of increasingly complex regulatory landscapes. The FDA’s proactive stance could catalyze AI adoption across the pharmaceutical and medical device industries.
The FDA's move to embrace AI reflects a broader trend in the healthcare industry toward leveraging advanced technologies to improve efficiency, accuracy, and patient outcomes. As the agency continues to assess the performance of these AI tools and gather user feedback, further enhancements will focus on improving usability, expanding document integration, and tailoring outputs to meet the specific needs of each center. This initiative marks a significant step toward modernizing the FDA’s review processes, with the ultimate goal of accelerating the approval of new therapies and ensuring the delivery of safe and effective treatments to the public.
