FDA releases guidance regarding civil money penalties

The Food and Drug Administration (FDA) has issued the final guidance titled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.” This guidance describes the authority of the FDA to assess civil money penalties against responsible parties of drug and device research who violate requirements to submit registration and/or results information to the ClinicalTrials.gov data bank. The guidance is available on FDA’s website.

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To learn more about the support available at the University of North Carolina at Chapel Hill for registering and submitting results for an investigator-initiated clinical trial in clinicaltrials.gov, visit UNC Research's clinicaltrials.gov information page.

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