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Ingested titles 12–51 and 54 from OLRC USLM XML @119-100 (the whole Code now, uniform edition; Title 53 is reserved/empty). LegalText 11,221 -> 59,740; repo total 105,704 records. Deterministic (byte-identical rerun, verified on Title 42's 8,356 sections); make check green. make legal-us-code default now covers every title. Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
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| LegalText | 21 U.S.C. § 360bbb–8a | Optimizing global clinical trials | us | united_states_code | code_section | 21 | FOOD AND DRUGS | 9 | FEDERAL FOOD, DRUG, AND COSMETIC ACT | 360bbb–8a | 21 U.S.C. § 360bbb–8a | current | 119-100 | 2026-06-26 | official | https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip | /us/usc/t21/s360bbb–8a | data/legal/raw/us/code/title-21/usc21.xml | 01348092c9d86ce82c1a80eb07d2916fc9c0486d0d7cc4a3d4fd21825e7f5357 | 3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1 | 0433e82a76f37168bbb18e1364a9422880fc509176361961075c306b3d3261a4 | 2026-07-04 | official |
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21 U.S.C. § 360bbb–8a - Optimizing global clinical trials
Text
(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.].
(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.)
Notes
Editorial Notes
References in TextThe 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.
Amendments2016—Subsec. (c). Pub. L. 114–255 inserted “or under the Public Health Service Act” before period at end.