Welcome to Insider issue #50.
Also, hello to the 610 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, Jonathan Wacks covers two new pieces of FDA guidance. The first addresses CMC flexibility for cell and gene therapy products pursuing a BLA, and the language in it is genuinely remarkable if you’ve spent a career inside traditional pharma manufacturing. No process validation for investigational product. No cGMP controls for Phase 1 safety studies. Permissive release criteria. Jonathan explains why the agency is doing this and what it actually requires of a CGT firm on the ground. The second is the finalized human factors guidance for device marketing submissions, which introduces a yes/no flowchart that finally right-sizes the HF data package to the actual risk of the device.
Leon Chagal closes the issue with a warning letter to GC America, Inc. It’s a textbook multi-system breakdown across component testing, stability, and data integrity, with a quality unit that had essentially gone dark. Leon walks through the citations and lays out what remediation actually looks like.
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