Fabio
76b8ec33a7
Ingested titles 12–51 and 54 from OLRC USLM XML @119-100 (the whole Code now, uniform edition; Title 53 is reserved/empty). LegalText 11,221 -> 59,740; repo total 105,704 records. Deterministic (byte-identical rerun, verified on Title 42's 8,356 sections); make check green. make legal-us-code default now covers every title. Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
44 lines
2.4 KiB
Markdown
44 lines
2.4 KiB
Markdown
---
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type: "LegalText"
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title: "21 U.S.C. § 360bbb–8b"
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description: "Use of clinical investigation data from outside the United States"
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jurisdiction: "us"
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corpus: "united_states_code"
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kind: "code_section"
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title_number: 21
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title_name: "FOOD AND DRUGS"
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chapter_number: "9"
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chapter_name: "FEDERAL FOOD, DRUG, AND COSMETIC ACT"
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section: "360bbb–8b"
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citation: "21 U.S.C. § 360bbb–8b"
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status: "current"
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release_point: "119-100"
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release_date: "2026-06-26"
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source: "official"
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source_url: "https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip"
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source_identifier: "/us/usc/t21/s360bbb–8b"
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source_file: "data/legal/raw/us/code/title-21/usc21.xml"
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source_hash: "6f4f18257cd4fe881f29a8e798070b7ed974acc48acc73290dc123107fe923e7"
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raw_snapshot_hash: "3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1"
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text_hash: "76cf502d382d01e976ba3d0ea8675fa6fc7053d6a97ac0aec54459b60c913423"
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retrieved_at: "2026-07-04"
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confidence: "official"
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tags: ["legal", "us-code"]
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---
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# 21 U.S.C. § 360bbb–8b - Use of clinical investigation data from outside the United States
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## Text
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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.
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(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.
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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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## Notes
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Editorial Notes
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Amendments2016—Pub. L. 114–255 substituted “drug, biological product, or device” for “drug or device” wherever appearing.
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