21 U.S.C. § 360bbb–8b — Use of clinical investigation data from outside the United States

FEDERAL · 21 U.S.C. · Chapter 9

Use of clinical investigation data from outside the United States

21 U.S.C. § 360bbb–8b

Title21 — Food and Drugs

Chapter9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT

SubchapterV

PartE

Current throughPub. L. 119-99

This text of 21 U.S.C. § 360bbb–8b (Use of clinical investigation data from outside the United States) is published on Counsel Stack Legal Research, covering United States primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook

21 U.S.C. § 360bbb–8b.

Text

(a)In general In determining whether to approve, license, or clear a drug, biological product, or device pursuant to an application submitted under this subchapter, the Secretary shall accept data from clinical investigations conducted outside of the United States, including the European Union, if the applicant demonstrates that such data are adequate under applicable standards to support approval, licensure, or clearance of the drug, biological product, or device in the United States.

(b)Notice to sponsor If the Secretary finds under subsection (a) that the data from clinical investigations conducted outside the United States, including in the European Union, are inadequate for the purpose of making a determination on approval, clearance, or licensure of a drug, biological product, or d

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(a) In general
In determining whether to approve, license, or clear a drug, biological product, or device pursuant to an application submitted under this subchapter, the Secretary shall accept data from clinical investigations conducted outside of the United States, including the European Union, if the applicant demonstrates that such data are adequate under applicable standards to support approval, licensure, or clearance of the drug, biological product, or device in the United States.
(b) Notice to sponsor
If the Secretary finds under subsection (a) that the data from clinical investigations conducted outside the United States, including in the European Union, are inadequate for the purpose of making a determination on approval, clearance, or licensure of a drug, biological product, or device pursuant to an application submitted under this subchapter, the Secretary shall provide written notice to the sponsor of the application of such finding and include the rationale for such finding.

Source Credit

History

(June 25, 1938, ch. 675, §569B, 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)(Q), Dec. 13, 2016, 130 Stat. 1155.)

Editorial Notes

Editorial Notes

Amendments
2016—Pub. L. 114–255 substituted "drug, biological product, or device" for "drug or device" wherever appearing.

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Bluebook (online)

21 U.S.C. § 360bbb–8b, Counsel Stack Legal Research, https://law.counselstack.com/usc/21/360bbb–8b.