eligible investigational drug
(2) the term “eligible investigational drug” means an investigational drug (as such term is used in section 360bbb of this title )— (A) for which a Phase 1 clinical trial has been completed; (B) that has not been approved or licensed for any use under section 355 of this title or section 351 of the Public Health Service Act [ 42 U.S.C. 262 ]; (C) (i) for which an application has been filed under section 355(b) of this title or section 351(a) of the Public Health Service Act [ 42 U.S.C. 262(a) ]; or (ii) that is under investigation in a clinical trial that— (I) is intended to form the primary basis of a claim of effectiveness in support of approval or licensure under section 355 of this title or section 351 of the Public Health Service Act [ 42 U.S.C. 262 ]; and (II) is the subject of an active investigational new drug application under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [ 42 U.S.C. 262(a)(3) ], as applicable; and (D) the active development or production of which is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under section 355(i) of this title ; and