July 2021: 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 July, 26th to Accuitis, Inc. for failing to submit required summary results information to ClinicalTrials.gov. The company also failed to update the primary completion date for their applicable clinical trial (ACT) within 30 days after the trial reached its primary completion date. The company’s applicable clinical trial evaluated the safety, efficacy, and tolerability of the drug ACCU-D1 in adult patients with moderate to severe acne rosacea.

The prenotice was issued on October 26, 2020, alerting Accuitis, Inc. to potential noncompliance with the requirement to submit clinical trial results. The trial’s results were recently made public in a medical journal, but journal publication does not satisfy FDA disclosure requirements. The Notice of Noncompliance gives Accuitis 30 days to submit the required summary results information. The FDA is authorized to seek civil monetary penalties for Accuitis’s violation, including additional civil money penalties if Accuitis 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 article: FDA threatens second company with fines over missing clinical trial results.


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