genetically targeted drug

(1) the term “genetically targeted drug” means a drug that— (A) is the subject of an application under section 355(b)(1) of this title or 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 in section 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;


21 USC § 360ff-1(c)(1)

Scoping language

For purposes of this section
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