April 2021: US Regulatory Update

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

FDA issued a press release on April, 28th FDA Takes Action for Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov announcing that a Notice of Noncompliance which was sent to Acceleron Pharma  for failing to submit required summary results information to ClinicalTrials.gov. The company’s applicable clinical trial evaluated the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma.

The prenotice was issued on July 20, 2020, alerting Acceleron to potential noncompliance with the requirement to submit clinical trial results. The Notice of Noncompliance gives Acceleron 30 days to submit the required summary results information. The FDA is authorized to seek civil money penalties for Acceleron’s violation, including additional civil money penalties if Acceleron fails to submit the required information within the 30-day period of issuance of this notice.

The Notice of Noncompliance has also been posted to the FDA’s website and information about the noncompliance will be 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.

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