Implications of FDA’s Decision to Issue Fines for Failing to Submit Clinical Trial Data

The U.S. Food and Drug Administration (FDA) issued a draft guidance last week proposing levying heavy fines on pharmaceutical companies and contract research organizations (CROs) that do not post clinical trial results online. FDA said in the draft guidance, titled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank,” that failure to register trials or submit results to ClinicalTrials.gov could result in fines up to $10,000 per day. FDA would first deliver a warning to responsible parties who would have thirty days to comply before any fines were issued.

Synchrogenix’s Vice President of Regulatory Strategy and Policy, Darshan Kulkarni got together with Nirpal Virdee, Synchrogenix's Director of Client Services and Brenda Tiffin, Synchrogenix’s Transparency and Disclosure Work Stream Lead to discuss the implications of FDA's decision to issue fines for failing to submit clinical trial data.

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Synchrogenix is committed to ensuring the accurate and efficient assessment of current sponsor compliance with posting on ClinicalTrials.gov, EudraCT, and other applicable worldwide registries. To learn more about our transparency and disclosure service offerings, including clinical trial postings and results disclosure, visit our website or contact us.

*Other articles mentioned in episode: 

  1. Failure to Report: A STAT Investigation of Clinical Trials Reporting
  2. Clinical Trials Often Unregistered, Unpublished

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