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
On August 31, 2021, the FDA issued the first Notice of Noncompliance to an individual investigator (after issuing two notices to pharmaceutical companies), 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). The investigator, as the responsible party, was given 30 days from the notice to submit the required results. The responsible party submitted results to ClinicalTrials.gov one day after the notice was posted.
Please note that the FDA allowed the investigator a reasonable time to respond to its notice. However, the FDA did not accept the investigator’s responses that study results could not be submitted because a manuscript was pending, or because they were short-staffed during the COVID-19 pandemic. We therefore ask researchers to consult with the UCSF ClincialTrials.gov Regulatory Support Team for assistance prior to responding to FDA regarding these matters.
The FDA has the authority to assess civil money penalties for failing to submit required clinical trial information.
More compliance actions will be forthcoming. Before receiving a Notice of Noncompliance, a responsible party will receive a Pre-Notice of Noncompliance. Both notices are delivered via UPS and email.
If you receive a Pre-Notice or Notice of Noncompliance, please contact the UCSF ClincialTrials.gov Regulatory Support Team. The FDA has more information here: ClinicalTrials.gov - Notices of Noncompliance and Civil Money Penalty Actions.
To check the status of your ACTs and the dates by which results are expected, please log into the ClinicalTrials.gov Protocol Registration and Results System (PRS).
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).