21 U.S.C. § 360bbb–8a: Optimizing global…

Summary

The Secretary must work with other countries’ regulators, medical research companies, and international groups to promote the same science-based rules for clinical trials around the world. The Secretary must also give consistent, parallel scientific advice to companies that want to develop new medical products in multiple countries at the same time to improve development, allow use of foreign data, and avoid repeating studies. Medical product means a drug (medicine), a device (medical equipment), or a biological product (made from living things). This does not change how safety or effectiveness of a medical product is judged under current law.

Title 21, §360bbb–8a

Food and Drugs, Source: USLM XML via OLRC

(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) of section 321 of this title, 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 [42 U.S.C. 262(i)].

(c)Savings clause

Nothing 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 [42 U.S.C. 201 et seq.].

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (c), is act July 1, 1944, ch. 373, 58 Stat. 682, 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 section 201 of Title 42 and Tables.

Amendments

2016—Subsec. (c). Pub. L. 114–255 inserted “or under the Public Health Service Act” before period at end.

§360bbb–8a Optimizing Global Clinical Trials