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FDA has consistently held that labeling a product "not for human use" or "for research purposes only" does not exempt it from drug regulations if the product is actually being sold for human use — and the agency evaluates the totality of circumstances, including marketing language, customer communications, and the nature of the product itself

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Cdh16cre identification: Cre primers amplified 400 bp bands indicating Cdh16Cre positive (Fig

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