Welcome to Insider issue #52.
Also, hello to the 214 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. Read our past deep dives here.
This month, Diamond Dent-Mitchell walks through the finalized guidance on formal meetings between the FDA and sponsors of PDUFA products. It replaces the 2017 and 2018 versions and rewrites the rules for every formal meeting a drug or biologic sponsor requests during development. We unpack the new 10-question ceiling, how briefing packages are due with the request for certain meeting types, a three-day window to confirm you still need a meeting, and the agency’s new authority to turn your meeting into a written response whether you agree or not!
Regina Atim covers the revised human factors guidance, updated August 3, 2026, and how it harmonizes usability engineering with your QMSR obligations. The short version: human factors stop being a standalone box to check and get wired into your actual design controls. Don’t miss this one if you’re on the device side.
Jesse Hart closes with the Linemaster Switch warning letter. It’s the first warning letter the FDA posted under the QMSR and the citations are written against the ISO 13485 clause. Jesse just finished a 483 remediation for a small manufacturer and recognized nearly every finding, so he walks both sides: what the agency cited, and what the fix actually looks like on paper.
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