No ice castles here, just cutting-edge AI. The FDA has officially launched Elsa, a generative AI tool built to help staff review clinical protocols, summarize safety data, identify inspection priorities, and even generate code for nonclinical databases.
Unlike her animated namesake, this Elsa doesn’t sing but she does work 24/7 to make regulatory operations faster, smarter, and more efficient.
· Summarizes adverse events
· Accelerates protocol reviews
· Flags high-priority inspections
· Generates internal code
· Built securely in GovCloud
· Launched ahead of schedule
· Doesn’t train on industry-submitted data
“Elsa is no longer a distant promise, she’s here, live, and working,” — Jeremy Walsh, FDA Chief AI Officer
The AI era at the FDA has officially begun. With Elsa, the agency is proving that AI and regulation aren’t at odds, they’re evolving together.
Is your organization ready for AI-driven compliance? Let’s connect and explore how life sciences can embrace this next wave of regulatory innovation.
