1. Regulations
  2. title 42
  3. chapter I
  4. part 11
  5. subpart A
  6. § 11.6

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