FDA Issues Second Notice of Noncompliance for Failure to Submit Results
Aug 5, 2021
On July 26, 2021, FDA issued a Notice of Noncompliance to a responsible party for failing to submit required results data to ClinicalTrials.gov. This is the second such Notice that FDA has issued this year.
In the Notice, FDA also indicates that the responsible party (Accuitis, Inc.) failed to update the Primary Completion Date within 30 dates of its occurrence.
In addition to the issuing of a Notice of Noncompliance, which remains permanently public, FDA is authorized to seek civil money penalties of up to $10,000 per day for failure to submit required information to ClinicalTrials.gov.
These new enforcement actions indicate an increase in risk to responsible parties and record owners with ClinicalTrials.gov compliance issues. If you have a record that is out of compliance (e.g. for late or missing results information), or if you need to register or update a record on ClinicalTrials.gov, contact [email protected].
In the Notice, FDA also indicates that the responsible party (Accuitis, Inc.) failed to update the Primary Completion Date within 30 dates of its occurrence.
In addition to the issuing of a Notice of Noncompliance, which remains permanently public, FDA is authorized to seek civil money penalties of up to $10,000 per day for failure to submit required information to ClinicalTrials.gov.
These new enforcement actions indicate an increase in risk to responsible parties and record owners with ClinicalTrials.gov compliance issues. If you have a record that is out of compliance (e.g. for late or missing results information), or if you need to register or update a record on ClinicalTrials.gov, contact [email protected].
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