21 U.S.C. § 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

section 321 of this title 42 U.S.C. 262(i)In this section, the term “medical product” means a drug, as defined in subsection (g) of , a device, as defined in subsection (h) of such section, or a biological product, as defined in section 351(i) of the Public Health Service Act [].

(c)

Savings clause

42 U.S.C. 201Nothing in this section shall alter the criteria for evaluating the safety or effectiveness of a medical product under this chapter or under the Public Health Service Act [ et seq.].

June 25, 1938, ch. 675, § 569A Pub. L. 112–144, title XI, § 1123July 9, 2012126 Stat. 1113 Pub. L. 114–255, div. A, title III, § 3101(a)(2)(P)Dec. 13, 2016130 Stat. 1154(, as added , , ; amended , , .)

Editorial Notes

References in Text

act July 1, 1944, ch. 373 58 Stat. 682 section 201 of Title 42The Public Health Service Act, referred to in subsec. (c), is , , which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under and Tables.

Amendments

Pub. L. 114–2552016—Subsec. (c). inserted “or under the Public Health Service Act” before period at end.