FDA Issues 4th Notice of Noncompliance for ClinicalTrials.gov Violations
Apr 21, 2022
On April 15, 2022, FDA issued a Notice of Noncompliance to a responsible party (Ocugen) for failing to submit required results data to ClinicalTrials.gov.
This is the fourth Notice that FDA has issued for ClinicalTrials.gov violations. FDA has also issued over 60 pre-notices since January 2020. Although pre-notices are not routinely made public by FDA, Universities Allied for Essential Medicine, a trial transparency advocacy organization, obtained and published many of these notices via a Freedom of Information Act request last year.
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, injunction, and even criminal prosecution of the responsible party for failure to submit required information to ClinicalTrials.gov.
FDA is ramping up enforcement, and the risk for noncompliance is increasing. 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] for help.
This is the fourth Notice that FDA has issued for ClinicalTrials.gov violations. FDA has also issued over 60 pre-notices since January 2020. Although pre-notices are not routinely made public by FDA, Universities Allied for Essential Medicine, a trial transparency advocacy organization, obtained and published many of these notices via a Freedom of Information Act request last year.
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, injunction, and even criminal prosecution of the responsible party for failure to submit required information to ClinicalTrials.gov.
FDA is ramping up enforcement, and the risk for noncompliance is increasing. 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] for help.
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