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

U.S Code last checked for updates: Nov 22, 2024

§ 360bbb–8a.

Optimizing global clinical trials

(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

(c)

Savings clause

(June 25, 1938, ch. 675, § 569A, as added Pub. L. 112–144, title XI, § 1123, July 9, 2012, 126 Stat. 1113; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(P), Dec. 13, 2016, 130 Stat. 1154.)

cite as: 21 USC 360bbb-8a