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In addition, restricted dosing volumes and the need for repeated administration may affect long-term treatment adherence (Keller et al., 2022

FDA asked Medline Industries to respond to its warning letter within 15 business days and noted that since the December 2025 inspection, the agency has updated its Quality System (QS) regulation to the Quality Management System Regulation (QMSR) to harmonize with international regulatory standards

doi: 10.1016/s0895-7061(01)02317-2 47 StroesEKasteleinJCosentinoFErkelensWWeverRKoomansHet al

Additionally, it summarizes strategies for treating copper imbalances through approaches such as copper chelators and ion carriers while discussing their limitations and future prospects