FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline (FDA)

In a major milestone, the FDA has completed its first generative AI-assisted scientific review pilot and announced an aggressive plan to deploy AI across all centers by June 30, 2025. Commissioner Dr. Martin Makary emphasized the need to eliminate administrative “busywork” and accelerate drug review timelines. The AI tools, already reducing multi-day review tasks to minutes, will be deployed through a secure, unified platform. Leadership has appointed a Chief AI Officer to oversee the rollout, signaling a transformative shift in regulatory science.