BS
Boise Standard
Treasure Valley · AI Directory
21 U.S.C. · Food and Drugs
21 U.S.C. § 360bbb8a

Optimizing global clinical trials

Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
Title 21 U.S.C. ● ACTIVE Primary Source Ch. 9
Statutory Text

21 U.S.C. § 360bbb8a — Optimizing global clinical trials

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V - DRUGS AND DEVICES Part E - General Provisions Relating to Drugs and Devices Sec. 360bbb-8a - Optimizing global clinical trials From the U.S. Government Publishing Office, www.gpo.gov

§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 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.)

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.

Source: uscode.house.gov — public domain Official Source ↗
Root-LD Entity Data
◈ Machine-Readable Provenance Record Root-LD v1.0 · boisestandard.org
Federation ID
BS-USC21-SEC-BCC0D9
Entity Class
STATUTE / FEDERAL-CODE-SECTION
Domain Signature
boisestandard.org
Citation
21 U.S.C. § 360bbb8a
Jurisdiction
Federal — United States
Status
✓ ACTIVE
Source
PRIMARY-SOURCE
Source Verified
✓ TRUE
Content Hash
d0e280279136eda0...
Semantic Edges
Pending — corpus passes queued
The statutory text of 21 U.S.C. § 360bbb8a is reproduced from the official United States Code as published by the Office of the Law Revision Counsel of the U.S. House of Representatives (uscode.house.gov).
Navigate Corpus — Title 21
← 21 U.S.C. § 360bbb8 21 U.S.C. § 360bbb8b →
Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
21 U.S.C. § 30121 U.S.C. § 32121 U.S.C. § 321a21 U.S.C. § 321b21 U.S.C. § 321c21 U.S.C. § 321d21 U.S.C. § 33121 U.S.C. § 33221 U.S.C. § 33321 U.S.C. § 333a21 U.S.C. § 33421 U.S.C. § 33521 U.S.C. § 335a21 U.S.C. § 335b21 U.S.C. § 335c21 U.S.C. § 33621 U.S.C. § 33721 U.S.C. § 337a21 U.S.C. § 34121 U.S.C. § 34221 U.S.C. § 34321 U.S.C. § 343121 U.S.C. § 343221 U.S.C. § 343321 U.S.C. § 343a21 U.S.C. § 34421 U.S.C. § 34521 U.S.C. § 34621 U.S.C. § 346a21 U.S.C. § 346b
21 U.S.C. — public domain ← All Legislation
◈ Provenance
boisestandard.org → United States → Law → U.S. Code → Title 21 → 21 U.S.C. § 360bbb8a