genetically targeted drug
(1)the term “genetically targeted drug” means a drug that— (A)is the subject of an application undersection 355(b)(1) of this titleor section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for the treatment of a rare disease or condition (as such term is defined insection 360bb of this title) that is serious or life-threatening; (B)may result in the modulation (including suppression, up-regulation, or activation) of the function of a gene or its associated gene product; and (C)incorporates or utilizes a genetically targeted technology;