The FDA announced the successful completion of its first pilot program integrating generative AI into its scientific review process and outlined an accelerated plan to implement AI broadly across all centers by June 30, 2025. Driven by promising pilot results, the agency aims to deploy generative AI tools to minimize repetitive tasks and speed up new therapy review times, freeing up scientists for higher-value work. A newly appointed Chief AI Officer will oversee the implementation to ensure security, usability, and compliance. The FDA will continue to enhance the system and share more updates in June, marking a significant milestone in modernizing the agency’s technology infrastructure while safeguarding public health.





























