Tip of the Week Archive

FDA Publishes Final Guidance on Civil Monetary Penalties Related to ClinicalTrials.gov Submissions

On August 12, 2020, FDA issued a final guidance document clarifying when and how FDA intends to seek civil monetary penalties for noncompliance with the clinical trial registration and results reporting requirements described in Title VIII of the Food and Drug Administration Amendments Act (FDAAA) and the regulations at 42 CFR Part 11 (the Final Rule).

 

The final guidance, “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank,” details FDA’s current thinking regarding how they intend to identify instances where responsible parties have:

• Failed to submit required clinical trial registration or results information to ClinicalTrials.gov for Applicable Clinical Trials (ACTs) involving FDA-regulated drug, biological, and device products;
• Submitted false or misleading information to ClinicalTrials.gov, and
• Failed to submit or knowingly submitted a false certification to the FDA.

 

The guidance also describes how and when FDA may seek civil money penalties for violations, as well as the procedures for assessing those penalties.