21 U.S.C. § 360n Priority Review to Encourage Treatments For Tropical Diseases

• Library: United States Statutes
• Edition: prefLabel,label,title,shortLabel
• Currency: Current through P.L. 118-19 (published on www.congress.gov on 10/06/2023)
• Citation: 21 U.S.C. § 360n

(a) Definitions

In 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(c) of the Food and Drug Administration Amendments Act of 2007.

(2) Priority review voucher

The term "priority review voucher" means a voucher issued by the Secretary to the sponsor of a tropical 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 262 of title 42 after the date of approval of the tropical disease product application.

(3) Tropical disease

The term "tropical disease" means any of the following:

(A) Tuberculosis.

(B) Malaria.

(C) Blinding trachoma.

(D) Buruli Ulcer.

(E) Cholera.

(F) Dengue/dengue haemorrhagic fever.

(G) Dracunculiasis (guinea-worm disease).

(H) Fascioliasis.

(I) Human African trypanosomiasis.

(J) Leishmaniasis.

(K) Leprosy.

(L) Lymphatic filariasis.

(M) Onchocerciasis.

(N) Schistosomiasis.

(O) Soil transmitted helmithiasis.

(P) Yaws.

(Q) Filovirus Diseases.

(R) Zika Virus Disease.

(S) Any other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations, designated by order of the Secretary.

(4) Tropical disease product application

The term "tropical disease product application" means an application that-

(A) is a human drug application as defined in section 379g(1) of this title-

(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 September 27, 2007.¹