FDA determines protamine sulfate intravenous solution (50 mg/5 mL) and related drug products were not withdrawn for safety or effectiveness reasons, permitting continued ANDA approvals for equivalent formulations.
Nelson & Isa Lacteos LLC recalls 1-pound packages of Requeson Cheese due to potential Listeria monocytogenes contamination posing serious health risks to vulnerable populations.
The FDA classifies absorbable metallic bone fixation fasteners as Class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burden for orthopedic device manufacturers.
FDA announces guidance exempting certain unclassified medical devices from premarket notification requirements, effective immediately but open to public comment.
FDA classifies shoulder joint humeral ceramic head/metallic stem cemented or uncemented prostheses as Class II medical devices, requiring special controls for manufacturer compliance.
FDA classifies resorbable calcium salt bone void fillers containing a single approved aminoglycoside antibacterial as Class II medical devices subject to special controls.
Ballester Hermanos is recalling 5.99oz bags of Pearl Milling Company Original Pancake & Waffles mix distributed in Puerto Rico due to undeclared soy and milk allergens.
Ballester Hermanos recalls Pearl Milling Company Original Pancake & Waffles Complete 5.99oz pouches distributed in Puerto Rico due to undeclared soy and milk allergens.
FDA finalizes M15 guidance on model-informed drug development, establishing harmonized assessment frameworks and documentation standards for pharmaceutical manufacturers using computational modeling in drug development.
FDA's third annual Animal Drug User Fee Educational Conference provides stakeholder education on the new animal drug approval process under the reauthorized user fee program through fiscal year 2028.
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