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.
This resource may be noteworthy to Health Law Scan readers working at academic medical centers. In light of the FDA’s latest action, clinical study sponsors in the biopharmaceutical industry and academic and medical institutions should review their current clinicaltrials.gov postings and ongoing clinical studies to determine whether all posting responsibilities have been met.
Read the full blog post from As Prescribed.