BS
Boise Standard
Treasure Valley · AI Directory
21 U.S.C. · Food and Drugs
21 U.S.C. § 360bbb8b

Use of clinical investigation data from outside the United States

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

21 U.S.C. § 360bbb8b — Use of clinical investigation data from outside the United States

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-8b - Use of clinical investigation data from outside the United States From the U.S. Government Publishing Office, www.gpo.gov

§360bbb–8b. Use of clinical investigation data from outside the United States

(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.

(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

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

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-07F3E9
Entity Class
STATUTE / FEDERAL-CODE-SECTION
Domain Signature
boisestandard.org
Citation
21 U.S.C. § 360bbb8b
Jurisdiction
Federal — United States
Status
✓ ACTIVE
Source
PRIMARY-SOURCE
Source Verified
✓ TRUE
Content Hash
32f62489ac898daa...
Semantic Edges
Pending — corpus passes queued
The statutory text of 21 U.S.C. § 360bbb8b 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. § 360bbb8a 21 U.S.C. § 360bbb8c →
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. § 360bbb8b