Originally published January 2026.
Welcome to Insider issue #45.
Also, hello to the 411 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 finalized IND safety reporting guidance that changes how sponsors should think about individual case reports versus aggregate analysis. The core message: stop flooding the FDA with uninformative safety reports. Not every serious adverse event requires an IND safety report—and submitting one that belongs in aggregate analysis is now a compliance issue, not a conservative practice.
For medical device companies, we’re covering eCopy compliance in the eStar era. Format holds aren’t caused by complex scientific issues—they’re triggered by preventable operational failures like naming errors and oversized PDFs. And our warning letter analysis covers a Wisconsin cleaning products company that meandered into OTC hand sanitizer production without understanding what that meant under cGMP.
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