21-U.S.C.-360BBB-8A

§360Bbb-8A – §360Bbb-8A. Optimizing Global Clinical Trials

Pathway

Title 21 > Chapter 9 > Subchapter V > Part E > Section 360bbb-8a

Details

• Reference: Section 360bbb-8a
• Legend: §360Bbb-8A – §360Bbb-8A. Optimizing Global Clinical Trials
• USCode Year: 2013

Provision Content

(a) In general

The Secretary shall—

(1) 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

(2) enhance the commitment to provide consistent parallel scientific advice to manufacturers seeking simultaneous global development of new medical products in order to—

(A) enhance medical product development;

(B) facilitate the use of foreign data; and

(C) minimize the need to conduct duplicative clinical studies, preclinical studies, or nonclinical studies.

(b) Medical product

In this section, the term medical product means a drug, as defined in subsection (g) of section 321 of this title, a device, as defined in subsection (h) of such section, or a biological product, as defined in section 262(i) of title 42.

(c) 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.)

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