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
Holiday week didn't slow the FDA down. Allison and Michael discuss new PMAs, pediatric gene therapy expansion, TAP enrollment growth, organ preservation technologies, and software guidance updates.