FDA Takes Action for Failure to Submit Required Clinical Trials Results to Clinicaltrials.gov Today, the FDA issued its first Notice of Noncompliance to Acceleron Pharma, Inc. (Acceleron) 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 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. 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 the National Institutes of Health (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. The FDA takes its role in enforcing the ClinicalTrials.gov registration and results information submission requirements extremely seriously and we will continue to encourage voluntary compliance with these requirements. When necessary, the FDA will take appropriate actions to help ensure that required information is available on ClinicalTrials.gov as required by law and for the benefit of clinical trial participants and public health. | 
No comments:
Post a Comment