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variant protein targeted drug

Defined in 1 place of the United States Code.

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.

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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.

Nothing in this section shall be construed to—

Source