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  • A product of biological origin applicable to the prevention, treatment, or cure of a disease or condition. Such products may include virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product. NOTE: Biological products may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell. Biological products are generally large, complex molecules and are often more difficult to characterize than small molecule drugs. [After 21 CFR 600.3; After FDA Biological Product Definitions] See also vaccine, cell therapy, gene therapy, pharmaceutical product, drug product, medicinal product.
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