The U.S. Food and Drug Administration (FDA) has issued a final guidance on “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank” outlining the agency’s current thinking regarding penalties imposed on responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products who violate federal requirements to submit registration and/or results information to the ClinicalTrials.gov data bank and/or certain certifications to FDA.
The guidance document addresses the following questions:
- How do the FDA’s Centers (e.g., for studies of drugs, biologics, and medical devices) intend to identify whether responsible parties have failed to submit required clinical trial registrations and/or results information to the ClinicalTrials.gov data bank or submitted false or misleading information to the data bank, or whether submitters have failed to submit to FDA the certification required by law or knowingly submitted a false certification to FDA?
- Under what circumstances may a Center decide to seek civil money penalties against a responsible party or submitter?
- What procedures apply when a Center seeks civil money penalties?
- What civil money penalty amounts may be assessed for (1) failing to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank, (2) submitting false or misleading information to the data bank, (3) failing to submit the required certification to FDA, or (4) knowingly submitting a false certification to FDA?
This guidance is now available on FDA’s website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/civil-money-penalties-relating-clinicaltrialsgov-data-bank.
Edited by Michael Causey