FDA may issue a Preliminary Notice of Noncompliance letter (Pre-Notice) to describe potential noncompliance with certain requirements under federal law for submitting registration and/or results information to ClinicalTrials.gov. Pre-notices may be issued for potential violations relating to, for example: 

• Failure to register an applicable clinical trial
• Failure to submit required clinical trial information for an applicable clinical trial
• Submission of false or misleading clinical trial information 

A Pre-Notice informs a responsible party of potential noncompliance with the legal requirements for registering and submitting results information to ClinicalTrials.gov. Pre-Notices request that the responsible party address any noncompliance within 30 days after receiving the letter. After a responsible party receives a Pre-Notice, FDA further reviews and assesses the clinical trial record as well as other relevant information to determine whether the responsible party has failed to submit required clinical trial information to the ClinicalTrials.gov data bank. If FDA determines that the responsible party failed to comply with the legal requirements, FDA will issue a Notice of Noncompliance. FDA may consider certain cases of potential noncompliance resolved without further action (e.g., when the responsible party is a defunct company), in which case FDA might decide to administratively close the matter. 

Pre-Notice of Noncompliance

The table below includes Pre-Notices issued as of December 2023. FDA intends to post Pre-Notices on a quarterly basis.