Particle.news
Download on the App Store
8 ARTICLES
·
4w ago

FDA Rolls Out Generative AI Assistant Elsa Agency-Wide Ahead of Schedule

Following White House AI governance guidance, the rollout marks a broader effort to modernize FDA workflows with in-house generative tools.

FDA headquarters at White Oak Campus in Silver Spring, Maryland, USA.
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly
Image
artificial intelligence AI Breaking Push white house FDA food and drug administration elsa

Overview

  • The FDA launched Elsa agency-wide on June 3, 2025, beating its June 30 deadline and staying under budget.
  • Elsa assists with summarizing internal reports, comparing drug labels, generating code for nonclinical databases and identifying high-risk inspection targets.
  • Hosted in a secure GovCloud environment, the tool keeps proprietary data within FDA systems to ensure confidentiality.
  • Early use of Elsa reduced a typical three-day scientific review task to just six minutes, signaling significant efficiency gains.
  • The agency plans to expand Elsa’s capabilities based on employee feedback even as it evaluates the readiness of other AI systems such as CDRH-GPT for medical device reviews.