FDA has the authority to issue a Notice of Noncompliance to a responsible party for failure to comply with certain requirements for registering and submitting results information to ClinicalTrials.gov. Following issuance of a Pre-Notice for voluntary corrective action, FDA conducts a further review and assessment of the clinical trial information submitted to ClinicalTrials.gov and any other relevant information to determine whether a violation exists. Failure to address potential violations after receiving the Pre-Notice may result in further FDA regulatory action, including a Notice of Noncompliance and/or civil money penalties.
A notice of noncompliance conveys FDA’s determination that the responsible party has committed one or more of the following violations:
- Failed to register an applicable clinical trial
- Failed to submit required clinical trial information to the ClinicalTrials.gov data bank
- Knowingly submitted false or misleading information
FDA has authority to assess civil money penalties for these violations. If a responsible party does not take adequate corrective action within 30 calendar days after receiving a Notice of Noncompliance, that responsible party may be subject to civil money penalties. Additionally, these violations could result in other regulatory or enforcement actions such as injunctions or criminal prosecution.
When considering civil money penalties, FDA will consider any corrective action that is taken by a responsible party after receiving a Pre-Notice and a Notice of Noncompliance. See Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank and 21 CFR part 17 for more information.
The table below lists the Notices of Noncompliance sent by FDA and the amount of civil money penalties assessed, if any, for each responsible party or submitter listed.
|Notice of Noncompliance
|Civil Money Penalty Amount
|Light Sciences Oncology
|Petrikovets, Andrey M.D.
|Acceleron Pharma, Inc.
- FDA's role: ClinicalTrials.gov information
- Federal Register notice: Delegation of Authority
- Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
- Expanded Clinical Trial Registry Data Bank
- Prohibited Acts
- Civil Money Penalties Hearings
- Clinical Trials Registration and Results Information Submission