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 humor This 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.