Skip to main content
Find a Lawyer

21 U.S.C. § 360bbb-8a - U.S. Code - Unannotated Title 21. Food and Drugs § 360bbb-8a. Optimizing global clinical trials

Current as of January 01, 2024 | Updated by Findlaw Staff

(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.

(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.

Previous Part of Code Next Part of Code
Back to Chapter List

Cite this article: FindLaw.com - 21 U.S.C. § 360bbb-8a - U.S. Code - Unannotated Title 21. Food and Drugs § 360bbb-8a. Optimizing global clinical trials - last updated January 01, 2024 | https://codes.findlaw.com/us/title-21-food-and-drugs/21-usc-sect-360bbb-8a/

FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.

Was this helpful?

Welcome to FindLaw's Cases & Codes

A free source of state and federal court opinions, state laws, and the United States Code. For more information about the legal concepts addressed by these cases and statutes, visit FindLaw’s Learn About the Law.

Go to Learn About the Law

Latest Blog Posts

For Legal Professionals

Learn About The Law

Get help with your legal needs

FindLaw’s Learn About the Law features thousands of informational articles to help you understand your options. And if you’re ready to hire an attorney, find one in your area who can help.

Go to Learn About the Law

Need to Find an Attorney?

Search our directory by legal issue

Enter information in one or both fields (Required)

Copied to clipboard