FDA Nudges Sponsors To Disclose Clinical Trial Results

The FDA recently reminded more than 2,200 companies and researchers to submit clinical trial results to ClinicalTrials.gov or complete the National Library of Medicine’s quality review process, as required under federal law. Applicable clinical trials involving FDA-regulated products are required to report results within one year of primary completion, yet an FDA analysis found that 29.6% of eligible studies had not submitted results.

Although the outreach was not a formal enforcement action, the FDA emphasized its authority to escalate noncompliance through Pre-Notices, formal Notices of Noncompliance, and civil penalties of up to $10,000 per day. Sponsors and investigators are encouraged to verify reporting timelines, delay certifications, and QC review status to ensure compliance and avoid future enforcement actions.