Source: https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360n&num=0&edition=prelim
Timestamp: 2019-08-22 11:08:38
Document Index: 430575636

Matched Legal Cases: ['§524', '§1102', '§2', '§2', '§3101', '§611', '§611']

[USC02] 21 USC 360n: Priority review to encourage treatments for tropical diseases
21 USC 360n: Priority review to encourage treatments for tropical diseases Text contains those laws in effect on August 21, 2019
(i) for prevention or treatment of a tropical disease;
(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
(June 25, 1938, ch. 675, §524, as added Pub. L. 110–85, title XI, §1102, Sept. 27, 2007, 121 Stat. 972 ; amended Pub. L. 113–233, §2, Dec. 16, 2014, 128 Stat. 2127 ; Pub. L. 114–146, §2, Apr. 19, 2016, 130 Stat. 357 ; Pub. L. 114–255, div. A, title III, §3101(a)(2)(M), Dec. 13, 2016, 130 Stat. 1154 ; Pub. L. 115–52, title VI, §611(a), Aug. 18, 2017, 131 Stat. 1054 .)
2017-Subsec. (a)(4)(A)(iii), (iv). Pub. L. 115–52 added cls. (iii) and (iv).
Pub. L. 115–52, title VI, §611(b), Aug. 18, 2017, 131 Stat. 1054 , provided that: "The amendments made by subsection (a) [amending this section] shall apply to human drug applications submitted after September 30, 2017."