FDA Disclosure: first noncompliance notice

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 was sent to Acceleron Pharma ”… for failing to submit required summary results information to ClinicalTrials.gov.”

The press release further states “……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.”

The notice of non-compliance is a signal for sponsors of the need to take into account that the FDA’s Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank guidance in managing the life cycle of clinical trialsClinical Trial Disclosure subject to publication.