FDA: Pre-Notices and Notices of Noncompliance
As of December 31, 2025, the Food & Drug Administration (FDA) had sent 226 Pre-Notices of Noncompliance and 8 Notices of Noncompliance to sponsors (companies and researchers) who failed to publish the results of their studies (Applicable Clinical Trial)) registered on ClinicalTrials.gov within the timeframe required by current regulations.
These procedures, of varying severity, are intended to ensure compliance, consistent with the provisions of the Food and Drug Administration and Amendments Act 801 and Final Rule.
Despite the publication requirement having been in effect since 2007, the percentage of registered studies with complete results is 78.1% (see https://fdaaa.trialstracker.net). Many sponsors still neglect this practice, thus exposing themselves to the risk of regulatory warnings and potential civil money penalties from the FDA.
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