42 CFR 11.6
§ 11.6 What are the requirements for the submission of truthful information?
United States · 42 CFR — Public Health · Status: effective
Cite this
- Citation
- 42 CFR 11.6, § 11.6 What are the requirements for the submission of truthful information?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/200533
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Full text
The clinical trial information submitted by a responsible party under this part shall not be false or misleading in any particular. A responsible party who submits false and/or misleading information is subject to civil monetary penalties and/or other civil or criminal remedies available under U.S. law.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.