Drug And Biologic : A Drug Essay
Biological products may also be considered as drugs in term of the FD&C Act. A biological product including virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood derived component, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), gene therapy products, growth factors, cytokines, and monoclonal antibodies used for prevention, treatment of a disease or condition of human beings needs license under section 351 of the Public Health Service Act 42 U.S.C. 262.
In addition to it, healthy individuals who are using substance to prevent pregnancy, and substance used to treat male pattern baldness also called a drug.
The guidance document is referenced above supporting to the IND regulations 21 CFR 312. As per the IND regulations in § 312.3(b) any approved or unapproved drug used for experiments involving, one or more human in clinical investigation required IND while use of a lawfully marketed drug for an unapproved use in the course of medical…