rare pediatric disease product application
(4) Rare pediatric disease product application The 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 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 .