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FDA Announces ClinicalTrials.Gov Enforcement Action

FDA recently announced enforcement action taken due to noncompliance with ClinicalTrials.gov requirements.  While the enforcement action noted in the FDA announcement was directed at an industry sponsor, FDA made clear that responsible parties of all types, including academic institutions, hospitals, and individual researchers, must ensure compliance with the requirements for registration and reporting of summary results.  Organizations who conduct clinical trials subject to the FDA and NIH rules should evaluate the systems that they have in place to ensure compliance and to promptly respond to any Pre-Notice or Notice of Noncompliance.  For more information please see the FDA announcement.