FDA Finalizes Guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

The U.S. Food and Drug Administration (FDA) has finalized guidance for civil money penalties related to reporting violations on the ClinicalTrials.gov website. The document details how the agency plans to identify if responsible parties have failed to submit required clinical trial registration or results information to the data bank, if they have submitted false or misleading information, or if they have failed to submit certification to the FDA. Additionally, the guidance lists the situations in which FDA may seek civil money penalties for noncompliance and the penalty amounts that could be assessed for ClinicalTrials.gov reporting violations. "Innovative advances in medical products and transparency in the clinical trials process depend on compliance with ClinicalTrials.gov submission requirements. Certain clinical trials must be registered, and summary results information for such clinical trials must, generally, be submitted within one year of the trial's primary completion date," says Anand Shah, MD, FDA's Deputy Commissioner for Medical and Scientific Affairs. Shah adds that while voluntary compliance with the law is optimal, "we intend to hold responsible parties and submitters accountable, including potential legal action, if they are not in compliance."

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