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  • https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_Biosciences/07%3A_The_Regulation_of_Biologics/7.05%3A_Section_5-
    Labeling here is referring to the display of written or printed material on the container or an enclosed document. Labeling includes both FDA approved labelings such as container labels, professional ...Labeling here is referring to the display of written or printed material on the container or an enclosed document. Labeling includes both FDA approved labelings such as container labels, professional labeling in the package insert (PI – prescribing information), patient labeling (PPI – patient package inserts), medication guides, and instructions for use. But also, any promotional material.

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