Drug And Biologic : A Drug Essay

1014 Words Oct 30th, 2015 5 Pages
No. According to this document drug and biologic both are considered as a Drug. Any article intended for use in treatment, diagnosis, cure mitigation or used in prevention of disease called drug as defined in section 201(g)(1) of the FD&C Act, not only that articles (except food) intended to affect the structure or any function of the body of man or other animals also called a drug.
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…

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