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FDA Reminds 2,200+ Companies Clinical Trial Disclosure Requirements

FDA issued reminder letters on March 30, 2026, to more than 2,200 medical product companies and researchers associated with over 3,000 clinical trials lacking required results submissions on ClinicalTrials.gov. The agency found that 29.6% of analyzed trials had not submitted results as mandated by FDAAA and the Final Rule at 42 C.F.R. Part 11. FDA stated it may issue Pre-Notices and Notices of Noncompliance if voluntary compliance is not achieved.