A system for documenting FDA violations of research reporting requirements, triggered when the FDA issues a Notice of Noncompliance to study researchers. The notice indicates failure to meet legal requirements under the Food and Drug Administration Amendments Act of 2007 (FDAAA 801), and includes three categories:

  • Violations: Marked when the FDA issues and posts a Notice of Noncompliance for: ◦ Failing to submit required study information ◦ Submitting false or misleading information ◦ Omitting primary and secondary outcomes
  • Corrections: Documented when researchers fix the violation and the FDA confirms and posts the correction, though there may be a delay between the update and the correction being noted
  • Penalties: Recorded when the FDA imposes and posts consequences for the violation

The National Library of Medicine must add this information to study records when provided by the FDA.

Eligibility criteria

Source

Expanded access typeFood and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801)