§ 360bbb–8b. Use of clinical investigation data from outside the United States
207 words·~1 min read·
/usc/title-21/section-360bbb-8bA research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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. 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 .)
Connections3 cite this · traces to 1
Cited by 3 sections
statute-compilations
Traces to 1 document
public-private-law
3 references not yet in our index
- Pub. L. 112-144
- 126 Stat. 1113
- 130 Stat. 1155
Citation graph
cites case law
§ 360bbb–8b
Use of clinical investigation data from outside the United States
Fed. Reg.×2
Stat. Comp.×1
Pub. L.Pub. L. 112-144
Stat.126 Stat. 1113
Stat.130 Stat. 1155
Cites 4Cited by 3 across 2 sources