The Good Bot: Artificial Intelligence, Health Care, and the Law · Brett A. Mason, Brent T. Hoard, Erin S. Whaley, Troutman Pepper Locke
Navigating FDA's 2025 AI Guidance: Risk-Based Framework, Public Comments, and Generative Models
·18 min·1 clip
The FDA's seven-step framework starts with a deceptively simple question that most pharmaceutical companies get wrong when implementing AI.
As heard by us
A practical guide to FDA's AI expectations for drug and biologic developers.
The episode frames FDA guidance on AI in drug and biologic development as a practical, risk-based playbook. Brett Mason and Kyle Dolinsky move through the 2025 updates, explain why context of use drives the framework, and stress that AI-informed decisions should be documented…
Why you'd press play
For when FDA AI guidance could change your next NDA or BLA.
Listen to the show on