2012 U.S. Code
Title 21 - Food and Drugs
Chapter 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT (§§ 301 - 399f)
Subchapter V - DRUGS AND DEVICES (§§ 351 - 360ddd-2)
Part E - General Provisions Relating to Drugs and Devices (§§ 360bbb - 360bbb-8c)
Section 360bbb-8b - Use of clinical investigation data from outside the United States
| Publication Title | United States Code, 2012 Edition, Title 21 - FOOD AND DRUGS |
| Category | Bills and Statutes |
| Collection | United States Code |
| SuDoc Class Number | Y 1.2/5: |
| Contained Within | 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 |
| Contains | section 360bbb-8b |
| Date | 2012 |
| Laws in Effect as of Date | January 15, 2013 |
| Positive Law | No |
| Disposition | standard |
| Source Credit | June 25, 1938, ch. 675, §569B, as added Pub. L. 112-144, title XI, §1123, July 9, 2012, 126 Stat. 1113. |
| Statutes at Large Reference | 126 Stat. 1113 |
| Public Law Reference | Public Law 112-144 |
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In determining whether to approve, license, or clear a drug 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 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 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.)
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