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

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

The following quote is attributed to Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs:

“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. “We expect the regulated community to comply with clinical trial requirements and regulations. “As in all areas that we regulate, our goal is to achieve voluntary compliance with the law. However, we intend to hold responsible parties and submitters accountable, including potential legal action, if they are not in compliance.”

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