Originally published October 2025.
Welcome to Insider issue #42.
Also, hello to the 105 life science professionals who joined us last month. If you haven’t already upgraded to a paid subscription to unlock our in-depth analysis issues like this one, you can do so here.
This month brings the FDA’s annual diagnostic scan of the pharmaceutical industry—and the signals are worth reading carefully. Warning letters hit a five-year high while recalls dropped to a five-year low. That’s not contradiction; it’s strategy! The FDA is getting more aggressive upstream, catching problems before they cause patient harm.
For medical device companies, the February 2, 2026 QMSR deadline is now close enough to feel. If you’re behind schedule, we’ve got a 120-day sprint plan. And our warning letter analysis covers a case that’s less about particles and more about how production pressure slowly corrodes quality culture.
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