§11.6. What are the requirements for the submission of truthful information?
42 C.F.R. § 11.6
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.
Notes, amendments, and revision history
Authority
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
Source: 81 FR 65138, Sept. 21, 2016, unless otherwise noted.