FDA Unveils AI Playbook for Drug Development

In a landmark move on January 2, 2025, the FDA released its first draft guidance for AI in drug and biologic development. Responding to a 200% surge in AI-driven submissions, especially in oncology and neurology, the guidance sets strict credibility and ethical benchmarks. Sponsors are encouraged to engage early, with public feedback open through April. FDA's multi-center collaboration ensures AI innovations meet high safety standards—because even robots need a good prescription!