April 2022: US Regulatory Update

FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.gov

The FDA issued a Notice of Noncompliance on April 15, 2022, to Ocugen for failing to submit required summary results information to ClinicalTrials.gov. The company’s applicable clinical trial evaluated the efficacy of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED).

The prenotice was issued on July 21, 2021, alerting Ocugen to potential noncompliance with the requirement to submit clinical trial results. The company failed to update the study results for their applicable clinical trial (ACT) within 30 days after the prenotice was issued. Upon receiving this notice of noncompliance, FDA provides Ocugen 30 days to submit the required summary results information. The FDA is authorized to seek civil monetary penalties for Ocugen’s violation, including additional civil money penalties and other regulatory action, such as injunction and/or criminal prosecution, without further notice, if Ocugen fails to submit the required information within the 30-day period.

The Notice of Noncompliance has been posted to the FDA’s website and information about the noncompliance has also been posted on the study record on ClinicalTrials.gov by NIH. NIH will continue to update the ClinicalTrials.gov records for applicable clinical trials that are the subject of a Notice of Noncompliance with information regarding whether the noncompliance has been corrected and the amount of civil money penalties assessed, if any.

For more information, please refer to the Letter of noncompliance on the FDA Website: Non-Compliance Letter