42 CFR 11.6 - What are the requirements for the submission of truthful information?

Regulations last checked for updates: Nov 22, 2024

Title 42 - Public Health last revised: Nov 19, 2024

View all text of Subpart A [§ 11.2 - § 11.10]

§ 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.

authority: 42 U.S.C. 282(i); 42 U.S.C. 282(j); 5 U.S.C. 301; 42 U.S.C. 286(a); 42 U.S.C. 241(a); 42 U.S.C. 216(b)

source: 81 FR 65138, Sept. 21, 2016, unless otherwise noted.

cite as: 42 CFR 11.6