Welcome to Insider issue #48.
Also, hello to the 412 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 brings a guidance document that pharma manufacturers have needed for years. Judson Russell walks through the FDA’s finalized guidance on responding to Form 483 observations, a document that started development in 2019 and now provides the clearest template the agency has ever published for structuring your response. This guidance should directly inform your readiness and response playbook.
Jesse Hart tackles the finalized weight loss device guidance that landed on March 13, 2026. After years of inconsistent review outcomes for this device category, the FDA has produced a structured benefit-risk framework with defined indication categories, clinical thresholds, and evaluation matrices.
Our warning letter analysis examines a letter to the maker of an autonomous insulin delivery device that independently determines and commands insulin doses. Michel Moravia dissects the citations across CAPA, risk management, complaint handling, and supplier controls, and explains why this letter signals a new standard of scrutiny for AI-driven medical devices.
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