tropical disease product application

(4)The term “tropical disease product application” means an application that— (A)is a human drug application as defined in— (i)for prevention or treatment of a tropical disease; and (ii)the Secretary deems eligible for priority review; (B)is approved after, by the Secretary for use in the prevention, detection, or treatment of a tropical disease; and (C)is for a human drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application undersection 355(b)(1) of this titleorsection 262 of title 42. (b)


21 USC § 360n(a)(4)

Scoping language

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