The U.S. Food and Drug Administration (FDA) has introduced Elsa, an advanced generative AI tool designed to enhance operational efficiency in scientific reviews and beyond. Elsa is already in use to expedite the evaluation of clinical protocols, facilitate scientific assessments, and pinpoint high-priority audit targets. This tool offers a secure platform that grants staff seamless access to internal documents, ensuring that confidential information remains within the agency's confines. Notably, the model's training process eschews data submitted by the regulated industry, thereby safeguarding sensitive information. The FDA aims to fully integrate the AI system by June 30th.