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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

However, despite these favorable achievements, anti-EpCAM monoclonal antibodies have not shown as much promise as initially indicated, and resistance to mAb has become a major obstacle recently