PRIA, Government Policy, Made Personal

Summary

The Secretary must work with other top drug and device regulators, medical research companies, and international groups to promote common, science-based rules for clinical trials worldwide. The Secretary must also give consistent, coordinated scientific advice to companies developing products in many countries so development improves, foreign data can be used, and repeating studies is reduced. Medical product means a drug, a device, or a biological product. Nothing here changes the legal rules for judging safety or effectiveness.

Title 21, §360bbb–8a

Food and Drugs, Source: USLM XML via OLRC

(a)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)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)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