(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
(c) Savings clause
Nothing in this section shall alter the criteria for evaluating the safety or effectiveness of a medical product under this chapter.
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 Tuesday, August 13, 2013
An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.