[Audio] Navigating FDA’s 2025 AI Guidance: Risk-Based Framework, Public Comments, and Generative Models – The Good Bot Podcast

In this episode of The Good Bot, recorded in August of this year, Brett Mason welcomes FDA regulatory attorney Kyle Dolinsky to unpack the FDA’s January 2025 draft guidance on artificial intelligence in drug and biologic development. They explain the agency’s seven-step, risk-based framework for model planning, development, validation, and monitoring, and highlight practical takeaways such as early FDA engagement and documentation expectations. The conversation explores themes from public…
By: Troutman Pepper Locke