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This followed an April 2021 announcement by the FDA that it has sent more than 40 pre-notices of noncompliance to encourage voluntary compliance with the ClinicalTrials.gov requirements 15 and an August 2020 final guidance on civil money penalties related to noncompliance, which emphasized its regulatory attention will prioritize trials of products that may pose a higher risk to human subjects or

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Mitra S, Behbahani H, Eriksdotter M

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