21 USC § 360bbb–8a - Optimizing global clinical trials

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This preliminary release may be subject to further revision before it is released again as a final version. As with other online versions of the Code, the U.S. Code Classification Tables should be consulted for the latest laws affecting the Code. Those using the USCPrelim should verify the text against the printed slip laws available from GPO (Government Printing Office), the laws as shown on THOMAS (a legislative service of the Library of Congress), and the final version of the Code when it becomes available.

Current through Pub. L. 112-173. (See Public Laws for the current Congress.)

(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) ofsection 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.

This preliminary release may be subject to further revision before it is released again as a final version. As with other online versions of the Code, the U.S. Code Classification Tables should be consulted for the latest laws affecting the Code. Those using the USCPrelim should verify the text against the printed slip laws available from GPO (Government Printing Office), the laws as shown on THOMAS (a legislative service of the Library of Congress), and the final version of the Code when it becomes available.

Current through Pub. L. 112-173. (See Public Laws for the current Congress.)

Source

(June 25, 1938, ch. 675, § 569A, as added Pub. L. 112–144, title XI, § 1123,July 9, 2012, 126 Stat. 1113.)

The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.

The most recent Classification Table update that we have noticed was Wednesday, December 26, 2012

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21 USC	Description of Change	Session Year	Public Law	Statutes at Large
§ 360bbb-8a	new	2012	112-144 [Sec.] 1123 "569A"	126 Stat. 1113

21 USC § 360bbb–8a - Optimizing global clinical trials

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