ClinicalTrials.gov - Notices of Noncompliance
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 action by FDA, including a Notice of Noncompliance.
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
If a responsible party does not take adequate corrective action within 30 calendar days after receiving a Notice of Noncompliance, FDA has authority to pursue regulatory or enforcement actions, which could include civil money penalties, injunctions, and/ or criminal prosecution.
The table below lists the Notices of Noncompliance sent by FDA.
| Responsible Party/Submitter | NCT Number | Notice of Noncompliance | Response Letter (if any) |
|---|---|---|---|
| Duchesnay Inc. | NCT02045901 |
| |
| Addex Pharma S.A. | NCT05116813 | ||
| Addex Pharma S.A. | NCT04857359 | ||
| Mantia-Smaldone, Gina M., M.D. | NCT03099499 | ||
| Mezzion Pharma Co. Ltd | NCT03013751 | 1/28/2026 | |
| FADOI Foundation | NCT03045406 | 12/19/2024 | 09/30/2025 |
| Light Sciences Oncology | NCT02326454 | 7/19/2023 | 11/22/2023 |
| Ocugen | NCT03785340 | 4/15/2022 | 08/01/2022 |
| Petrikovets, Andrey M.D. | NCT03052816 | 8/31/2021 | 12/20/2021 |
| Accuitis Inc. | NCT03064438 | 7/26/2021 | 05/26/2022 |
| Acceleron Pharma, Inc. | NCT01727336 | 4/27/2021 | 12/13/2021 |