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21 U.S. Code § 360ff. Priority review to encourage treatments for rare pediatric diseases
(a) DefinitionsIn this section:
(1) Priority review
The term “priority review”, with respect to a human drug application as defined in section 379g(1) of this title, means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012.
(2) Priority review voucher
The term “priority review voucher” means a voucher issued by the Secretary to the sponsor of a rare pediatric disease product application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] after the date of approval of the rare pediatric disease product application.
(3) Rare pediatric diseaseThe term “rare pediatric disease” means a disease that meets each of the following criteria:
(A)
The disease is a serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents.
(B)
The disease is a rare disease or condition, within the meaning of section 360bb of this title.
(4) Rare pediatric disease product applicationThe term “rare pediatric disease product application” means a human drug application, as defined in section 379g(1) of this title, that—
(A)
is for a drug or biological product that is for the prevention or treatment of a rare pediatric disease;
(B)
(i) is for such a drug—
(I)
that contains no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been previously approved in any other application under subsection (b)(1), (b)(2), or (j) of section 355 of this title; and
(II)
that is the subject of an application submitted under section 355(b)(1) of this title; or
(ii) is for such a biological product—
(I)
that contains no active ingredient that has been previously approved in any other application under section 351(a) or 351(k) of the Public Health Service Act [42 U.S.C. 262(a), 262(k)]; and
(II)
that is the subject of an application submitted under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)];
(C)
the Secretary deems eligible for priority review;
(D)
that [1] relies on clinical data derived from studies examining a pediatric population and dosages of the drug intended for that population;
(E)
that 1 does not seek approval for an adult indication in the original rare pediatric disease product application; and
(F)
is approved after September 30, 2016.