Overview
In April 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.
FDA issues first Notice of Noncompliance for failure to submit results for an Applicable Clinical Trial to ClinicalTrials.gov
On April 28, 2021, the FDA issued the first Notice of Noncompliance external site (opens in a new window) to Acceleron Pharma, Inc., for a failure to submit required clinical trial results data for an Applicable Clinical Trial (ACT) external site (opens in a new window) to ClinicalTrials.gov in accordance with FDA regulations (FDAAA 801 external site (opens in a new window) ).
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 external site (opens in a new window) .
More compliance actions will likely be forthcoming.
Receiving a Notice
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
Contact the UCSF ClincialTrials.gov Regulatory Support Team external site (opens in a new window) .
For more information:
- FDA Statement: FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov external site (opens in a new window)
- National Law Review: FDA Ups the Ante and Sends First Notice of Noncompliance for Failure to Submit Clinical Trial Results external site (opens in a new window)
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) external site (opens in a new window) .