How to Engage FDA Strategically: Mitchell Glass, M.D.

Regulation doesn’t have to be a black box.Learn how and when to engage FDA, what regulators expect early, and how smart interaction reduces risk and wasted effort.This episode helps founders understand how to engage FDA early and productively. Dr. Glass explains when to initiate regulatory conversations, what agencies are really looking for, and how early feedback can shape smarter development strategies. You’ll learn how to avoid common regulatory missteps and how to view FDA as a partner in risk reduction rather than an obstacle. For academic and first-time founders who find regulation intimidating or opaque, this conversation brings clarity, structure, and confidence to one of the most critical (and misunderstood) parts of building a life-science company.