Title 42

SECTION 11.6

11.6 What are the requirements for the submission of truthful information

§ 11.6 What are the requirements for the submission of truthful information?

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.

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