human drug application
(1) The term “human drug application” means an application for— (A) approval of a new drug submitted under section 355(b) of this title , or (B) licensure of a biological product under subsection (a) of section 262 of title 42 . Such term does not include a supplement to such an application, does not include an application with respect to whole blood or a blood component for transfusion, does not include an application with respect to a bovine blood product for topical application licensed before September 1, 1992 , does not include an application with respect to an allergenic extract product licensed before October 1, 2022 , does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022 , does not include an application with respect to an in vitro diagnostic biologic product licensed under section 262 of title 42 , does not include an application with respect to a large volume parenteral drug product approved before September 1, 1992 , does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does include an application for licensure, as described in subparagraph (B), of a large volume biological product intended for single dose injection for intravenous use or infusion.