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21 CFR 812.42

Sponsor began study before IRB/FDA approval

  • Inspections citing it: 8
  • Of those classified, ended OAI: 75%
  • Last cited: FY2021

Inspections Citing It by Fiscal Year

Sites in and outside the US, FY2017 to Oct 20, 2026.

Regulation Text

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Open 21 CFR 812.42 on eCFR

Counts are inspections with posted citations that cite any paragraph of the section, once per inspection, from FDA's Data Dashboard. OAI share is over inspections FDA finally classified. Text from eCFR, the official online CFR. FDA Data Dashboard and eCFR

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.