Trying to Keep Up

The FDA moves fast. Guidance changes. Policies evolve. Submissions get weird.Former-FDA reviewers Michael Nilo and Allison Komiyama started Trying To Keep Up for a simple reason: they were already spending time each week to jump on a call and ask, “Wait…what just happened at CDRH?”So they turned that call into a live conversation.Each week they (try to) unpack what’s actually happening at CDRH...from policy changes and regulatory curveballs to the ripple effects hitting real companies, real submissions, and real timelines.Expect:• Hot takes on FDA updates• Deep regulatory dives (and occasionally shallow ones)• Guests, Q&A, and off-script conversations• A healthy dose of jokes and regulatory nerd humorThis isn’t a polished podcast and there’s no rigid agenda...just two former FDAers (and sometimes guests) talking through a regulatory landscape that seems to change by the week. If you work in MedTech and sometimes feel like the rules changed overnight…you’re not alone.We’re all just trying to keep up.