Welcome to Insider issue #46.
Also, hello to the 421 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.
In this month’s analysis, Judson Russell examines the FDA’s draft guidance on Bayesian methodology in clinical trials—a framework that could fundamentally change how sponsors approach trial design for rare diseases, pediatric populations, and fast-moving therapeutic areas like oncology. Drawing on direct experience in gene therapy submissions and pediatric rare disease programs, he breaks down what the guidance means operationally and where the real opportunities lie for companies willing to invest in the methodology.
Our MedTech section features Leon Chagal’s detailed analysis of the FDA’s finalized guidance on real-world evidence for medical devices. The piece provides a comprehensive operational framework for evaluating RWD sources, building validated linkage strategies, addressing confounding through causal models, and structuring submissions that meet the guidance’s relevance and reliability requirements. This guidance has broad implications across the device lifecycle, from 510(k) clearances through postmarket surveillance.
Finally, Diamond Dent-Mitchell dissects two warning letters that reveal persistent cGMP failures in pharmaceutical manufacturing. The Winder case is particularly instructive: an eight-year compliance timeline showing the same issues cycling through inspection after inspection, with CAPA that addresses symptoms without changing system capability. The analysis provides actionable guidance on cleaning program design, equipment qualification, facility maintenance, and the governance structures needed to break the repeat-violation cycle.
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