21 U.S. Code § 360bbb–8a - Optimizing global clinical trials

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(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) ofsection 321 of this title, a device, as defined in subsection (h) of such section, or a biological product, as defined in section 262 (i) of title 42.
(c) Savings clause
Nothing in this section shall alter the criteria for evaluating the safety or effectiveness of a medical product under this chapter.

Source

(June 25, 1938, ch. 675, § 569A, as added Pub. L. 112–144, title XI, § 1123,July 9, 2012, 126 Stat. 1113.)

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21 CFR - Food and Drugs

21 CFR Part 4 - REGULATION OF COMBINATION PRODUCTS

21 CFR Part 5 - ORGANIZATION

21 CFR Part 7 - ENFORCEMENT POLICY

21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES

21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING

21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

21 CFR Part 20 - PUBLIC INFORMATION

21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

21 CFR Part 312 - INVESTIGATIONAL NEW DRUG APPLICATION

 

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