Two weeks ago, the FDA announced the successful completion of its first AI-assisted scientific review pilot at the Center for Drug Evaluation and Research (CDER). The pilot demonstrated significant time savings, with tasks previously taking days now completed in minutes. Jinzhong Liu, Deputy Director at CDER, noted the AI tool's ability to summarize documents and flag inconsistencies, allowing reviewers to focus on complex issues.
Following this success, today, FDA Commissioner Dr. Martin Makary directed all FDA centers to deploy generative AI tools by June 30, 2025. The agency appointed Jeremy Walsh as its first Chief AI Officer and Sridhar Mantha as Senior Advisor on AI to lead this initiative.
The AI system will be integrated with FDA’s internal data platforms, tailored to each center's needs, and comply with federal information systems standards. The FDA emphasized that AI tools are intended to support, not replace, human reviewers.
This move signifies a broader cultural shift within the FDA, embracing emerging technologies to meet the demands of increasingly complex submissions and high application volumes. However, questions remain regarding transparency in AI usage during reviews, protection of proprietary data, and potential impacts on review timelines.
Companies are advised to prepare for this shift by ensuring their submissions are AI-ready, using structured formats, maintaining consistency, and organizing content logically. Staying informed about future FDA guidance on AI-assisted reviews will be crucial.