Trying to Keep Up
with Michael Nilo & Allison Komiyama
A weekly live call where two regulatory nerds talk about what's actually happening at the FDA's CDRH and how it's affecting real teams, real timelines, and real decisions
A weekly live call where two regulatory nerds talk about what's actually happening at the FDA's CDRH and how it's affecting real teams, real timelines, and real decisions
Former FDA branch chief David Pudwill joins TTKU to talk AI ECGs, pediatric devices, drug shortages, biocompatibility, cybersecurity, and FDA updates.
Former FDA reviewer Laura Rose joins TTKU to discuss FDA benefit-risk decisions, Breakthrough Devices, regulatory pushback, PFAS, BCIs, and new medical device guidance.