2016 US Code
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
| 21 U.S.C. § 360bbb-8b (2016) |
| §360bbb–8b. Use of clinical investigation data from outside the United States |
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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 sponsorIf 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. |
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(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.) |
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AMENDMENTS
2016—Pub. L. 114–255 substituted "drug, biological product, or device" for "drug or device" wherever appearing. |
| United States Code, 2012 Edition, Supplement 4, Title 21 - FOOD AND DRUGS |
| Bills and Statutes |
| United States Code |
| Y 1.2/5: |
| 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 |
| section 360bbb-8b |
| 2016 |
| January 6, 2017 |
| No |
| standard |
| 126 Stat. 1113 130 Stat. 1155 |
| Public Law 112-144, Public Law 114-255 |
