The
In a strongly worded statement, the FDA reminded stakeholders that federal law requires responsible parties (typically trial sponsors,) to register applicable clinical trials on ClinicalTrials.gov within 21 days of the first human subject being enrolled and submit certain summary results information for those trials, generally no later than a year after the study's completion date, unless a deadline extension is obtained. It stated, "being transparent about the results of completed clinical trials enables important advances in the development of medical products and helps ensure a safe, effective and efficient clinical research enterprise."
The agency determines whether responsible parties are complying with these legal requirements and has the authority to take enforcement action when they are not met.
The regulator has previously outlined its approach to identifying whether responsible parties have failed to submit required registration and/or summary results information to the ClinicalTrials.gov data bank for trials studying drug products, biological products and device products. "Although many responsible parties comply with the law without FDA action, the agency has sent Pre-Notices of Noncompliance (more than 40 to date) to encourage voluntary compliance with the ClinicalTrials.gov requirements," it stated.
In the case of Acceleron, the FDA said it had determined that the responsible party, who received a Pre-Notice of Noncompliance in
The regulator stated that the Notice of Noncompliance has been posted to the
The FDA concluded its statement with, "the FDA takes its role in enforcing the ClinicalTrials.gov registration and results information submission requirements extremely seriously" adding that though it would continue to encourage voluntary compliance, it would take "appropriate actions" to ensure that information is available on ClinicalTrials.gov as required by law.
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