Zdrowie i gospodarka · 05/06/2026

FDA Classifies Resorbable Calcium Salt Bone Filler with Aminoglycoside Antibacterial into Class II with Special Controls

The FDA has classified the resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial into Class II, a category that requires special controls to ensure the product's safety and effectiveness, with the aim of reducing regulatory burdens and enhancing patient access to innovative products.

Source: Federal Register — Health and Human ServicesOpen original release →

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