Trying to Keep Up
with Allison Komiyama & Michael Nilo
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
QMSR officially launches, FDA rolls out Tempo, and Allison Kumar joins TTKU to unpack PMAs, guidance updates, hiring, and real-world evidence.
The team unpacks the truth behind breakthrough designation, FDA review realities, new cancer technologies, and the return of CDRH News.
The team unpacks reclassifications, AI pregnancy tech, weight loss balloons, and FDA’s latest moves in digital health, orthopedics, and rare disease policy.
The team unpacks reclassifications, AI pregnancy tech, weight loss balloons, and FDA’s latest moves in digital health, orthopedics, and rare disease policy.