variant protein targeted drug

(3) the term “variant protein 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) modulates the function of a product of a mutated gene where such mutation is responsible in whole or in part for a given disease or condition; and (C) is intended to treat one or more patient subgroups, including subgroups of patients with different mutations of a gene, with the same disease or condition.


21 USC § 360ff-1(c)(3)

Scoping language

For purposes of this section
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