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Editor's note: The original article, published in Undark and co-published with STAT , draws on a seven-month investigation by journalist Sara Talpos

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

Experimental evidence suggests an involvement in vascular remodeling through stimulation of new microvessel development, alongside regulation of nitric oxidedependent signaling

This decision reverses a previous ruling that placed approximately 19 peptides on the more restrictive Category 2 list, effectively banning their use in compounded medications due to potential significant safety risks. The reversal came after significant debate and legal challenges from medical providers and pharmacy groups, who argued that the FDA had not presented sufficient evidence to justify the ban