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FDA Issues Fourth Notice of Noncompliance with ClinicalTrials.gov Requirements

In April of 2021, the FDA issued its first Notice of Noncompliance to a company failing to submit required summary results information to ClinicalTrials.gov. This April, they have issued the 4th notice of its kind. They determined that the responsible party failed to comply with the requirement to submit clinical trial results information to the ClinicalTrials.gov data bank, as required by section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Consequences for noncompliance can include civil monetary penalties for both the violation and the failure to submit the required information.

Visit the FDA’s ClinicalTrials.gov notices of noncompliance page for more information including a list of previous noncompliance notices.


 

CITI Program’s ClinicalTrials.gov Content

Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov

This course provides a video-enhanced guide to compliance with the FDAAA Final Rule and NIH Policy on clinical trial disclosure in ClinicalTrials.gov.
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Building a ClinicalTrials.gov Compliance Program – Tips for Investigators and Institutions

Reviews reporting regulations, noncompliance, and discusses how to build a successful compliance monitoring program.
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ClinicalTrials.gov Enforcement: An Update

Explores recent FDA enforcement of FDAAA 801 and noncompliance pitfalls to avoid.
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