Source: http://www4.law.cornell.edu/uscode/text/21/360bbb-8a?quicktabs_8=0
Timestamp: 2013-12-10 12:16:02
Document Index: 731489025

Matched Legal Cases: ['§ 360', '§ 360', '§ 360', '§ 569', '§ 1123', '§ 360']

21 USC § 360bbb–8a - Optimizing global clinical trials | Title 21 - Food and Drugs | U.S. Code | LII / Legal Information Institute
USC › Title 21 › Chapter 9 › Subchapter V › Part E › § 360bbb–8a	prevnext
21 USC § 360bbb–8a - Optimizing global clinical trials
work with other regulatory authorities of similar standing, medical research companies, and international organizations to foster and encourage uniform, scientifically driven clinical trial standards with respect to medical products around the world; and
enhance the commitment to provide consistent parallel scientific advice to manufacturers seeking simultaneous global development of new medical products in order to—
enhance medical product development;
facilitate the use of foreign data; and
minimize the need to conduct duplicative clinical studies, preclinical studies, or nonclinical studies.
Medical product In this section, the term “medical product” means a drug, as defined in subsection (g) ofsection 321 of this title, a device, as defined in subsection (h) of such section, or a biological product, as defined in section 262
Savings clause Nothing in this section shall alter the criteria for evaluating the safety or effectiveness of a medical product under this chapter.
(June 25, 1938, ch. 675, § 569A, as added Pub. L. 112–144, title XI, § 1123,July 9, 2012, 126 Stat. 1113.)
21 USCDescription of ChangeSession YearPublic LawStatutes at Large § 360bbb-8anew2012112-144 [Sec.] 1123 "569A"126 Stat. 1113 LII has no control over and does not endorse any external Internet site that contains links to or references LII.