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radar Health Law Scan

Legal Insights and Perspectives for the Healthcare Industry
Clinical Trials

Check It Out: Fourteen Years Later, FDA Flexes Its Clinicaltrials.gov Enforcement Authority

Our US Food and Drug Administration (FDA) team recently published a blog post discussing the FDA’s issuance of its first clinicaltrials.gov notice of noncompliance to a clinical trial sponsor for failure to submit clinical trial results to the National Institutes of Health databank. While the authority to issue such notices has existed since the 2007 passage of the Food and Drug Administration Amendments Act, this is the first time the FDA has exercised its clinicaltrials.gov enforcement authority.