rare pediatric disease product application

(4)The term “rare pediatric disease product application” means a human drug application, as defined in, that— (A)is for a drug or biological product— (i)that is for the prevention or treatment of a rare pediatric disease; and (ii)that contains no active ingredient (including any ester or salt of the active ingredient) that has been previously approved in any other application underor section 351(a) or 351(k) of the Public Health Service Act [42 U.S.C. 262(a), 262(k)]; (B)is submitted undersection 355(b)(1) of this titleor 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 1relies on clinical data derived from studies examining a pediatric population and dosages of the drug intended for that population; (E)that does not seek approval for an adult indication in the original rare pediatric disease product application; and (F)is approved after. (b)


21 USC § 360ff(a)(4)

Scoping language

In this section
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