FDAAA 801 Violation

**Semantic type:** Research Activity

**Definition:** A violation of Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) that requires responsible parties to register and submit study results of clinical trials with ClinicalTrials.gov. The three types of violations are: failure to submit required clinical trial information; submission of false or misleading clinical trial information; failure to submit primary and secondary outcomes.

**Synonyms:** - Violation of Section 801 of the Food and Drug Administration Amendments Act