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Clinical Trial Reporting: US FDA To Step Up Listings, But Not Fines, After Petition

 
• By Brenda Sandburg

Following request by Universities Allied for Essential Medicines, FDA creates a public dashboard of pre-notices of noncompliance on registering trials and submitting results to ClinicalTrials.gov. The agency denies request to impose civil penalties on those who fail to comply, citing its discretion.

Clinical trial blue with lock
FDA agrees to make pre-notices of noncompliance with clinical trial reporting requirements public • Source: Shutterstock

The US Food and Drug Administration quietly implemented a citizen petition request to make its pre-notices of noncompliance with ClinicalTrials.gov reporting requirements publicly available. But the agency denied calls for it to beef up enforcement and impose civil monetary penalties.

Key Takeaways
  • FDA’s petition response is a quiet acknowledgement that it could be doing more to encourage ClinicalTrials.gov listings.

Universities Allied for Essential Medicines North America (UAEM), an international nonprofit promoting health equity and access to medicines, submitted the...

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