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Dysbiosis amplifies barrier dysfunction and immune activation, while inflammation further perturbs microbial composition and impairs epithelial repair, establishing a self-sustaining pathological cycle

On April 30, 2026, the FDA further proposed formally excluding both from the 503B Bulks List - a proposal that, if finalized after the June 29, 2026 comment period, would close the remaining large-scale outsourcing facility pathway

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The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 25 August 2021