Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics
Camargo
NOVEMBER 29, 2021
Section 351 of the Public Health Service (PHS) Act defines a biological product as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product. Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms.
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