On June 2, 2025, the United States Food and Drug Administration (FDA) proudly launched Elsa, an advanced generative AI tool, ahead of its scheduled timeline. Deployed securely on the GovCloud platform, Elsa adheres strictly to the zero-data-outflow principle, ensuring data integrity and security. Designed to empower FDA staff, Elsa aims to enhance work efficiency, expedite clinical reviews, facilitate intelligent monitoring, and ultimately catalyze the modernization of regulatory processes. This groundbreaking project, a testament to the seamless collaboration among internal experts, was not only delivered ahead of schedule but also within budget constraints.