Biologic Product

[FDA] FDA: A biologic product is any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment, or cure of diseases or injuries. Biologic products are a subset of “drug products” distinguished by their manufacturing processes (biological process vs. chemical process). In general, the term “drugs” includes biologic products.

Source: Section 351 of the Public Health Service (PHS) Act


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