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; (ii)the Secretary deems eligible for priority review; (iii)that contains reports of one or more new clinical investigations (other than bioavailability studies) that are essential to the approval of the application and conducted or sponsored by the sponsor of such application; and (iv)that contains an attestation from the sponsor of the application that such reports were not submitted as part of an application for marketing approval or licensure by a regulatory authority in India, Brazil, Thailand, or any country that is a member of the Pharmaceutical Inspection Convention or the Pharmaceutical Inspection Cooperation Scheme prior to.1 (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)

Source

21 USC § 360n(a)(4)


Scoping language

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