FDA Output
FDA Output, March 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in March 2026. Updated March 16.
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Investors & Dealmaking
2025 Data Is In: Diagnostics Is Having a Renaissance
The diagnostic industry, a perpetual valuation laggard to higher-profile subsectors of the life sciences, with a short-lived exception during the height of COVID-19, may finally be having a moment. Reflecting this optimism, industry experts on a recent Arizona State University online seminar highlighted the success of rising young and increasingly profitable tech-enabled diagnostics companies, labeling them the “Terrific 10,” a moniker that references the tech industry’s “Magnificent 7.”
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Pathways’ Pick of the Week
Pathways' Pick of the Week: FDA Launches a New Framework for FDA Inspections
FDA’s new Quality Management System Regulation takes effect. Excerpted from Pathways’ Pick of the Week March 4: FDA Adopts QMSR, EU Harmonizes Standards, South Korea Spotlights Innovation.