21 U.S.C. § 360bbb-8a
Section 360bbb-8a · Optimizing global clinical trials
Current version, with additions and removals from the July 9, 2012 version.
The Secretary shall—
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
(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—
(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;
(A) enhance medical product development;
(B) facilitate the use of foreign data; and
(B) facilitate the use of foreign data; and
(C) minimize the need to conduct duplicative clinical studies, preclinical studies, or nonclinical studies.
(C) minimize the need to conduct duplicative clinical studies, preclinical studies, or nonclinical studies.