NIH Strengthens Enforcement for Delayed Clinical Trials Reporting
June 9, 2023
FDA Issues First Notice of Noncompliance to an Individual Investigator for Failure to Submit Results for an Applicable Clinical Trial to ClinicalTrials.gov
September 30, 2021
FDA Issues First Notice of Noncompliance for Failure to Submit Results for an Applicable Clinical Trial to ClinicalTrials.gov
June 1, 2021
On April 28, 2021, the FDA issued the first Notice of Noncompliance to Acceleron Pharma, Inc., for a failure to submit required clinical trial results data for an Applicable Clinical Trial (ACT) to ClinicalTrials.gov in accordance with FDA regulations (FDAAA 801). If the responsible party, Acceleron Pharma, Inc., does not submit the required results within 30 days from the receipt of the Notice of Noncompliance, the FDA may seek civil money penalties, injunction, and/or criminal prosecution.
More compliance actions will likely be forthcoming. Before receiving a Notice of Noncompliance, a responsible party will receive a Pre-Notice of Noncompliance. Both notices are delivered via physical letter (via UPS) sent to the responsible party’s mailing address in their ClinicalTrials.gov user account. The Notice of Noncompliance will be publicly posted, but the Pre-Notice of Noncompliance is only sent to the responsible party as designated in each ClinicalTrials.gov study record.
If you receive a Pre-Notice or Notice of Noncompliance, please contact the UCSF ClincialTrials.gov Regulatory Support Team.
For more information:
- FDA Statement: FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov
- National Law Review: FDA Ups the Ante and Sends First Notice of Noncompliance for Failure to Submit Clinical Trial Results
To check the status of your ACTs and dates by which results are expected, please log into the ClinicalTrials.gov Protocol Registration and Results System (PRS).