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FDA Issues First Notice of Noncompliance for Failure to Submit Results for an Applicable Clinical Trial to

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 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 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 study record.

If you receive a Pre-Notice or Notice of Noncompliance, please contact the UCSF Regulatory Support Team.

For more information:

To check the status of your ACTs and dates by which results are expected, please log into the Protocol Registration and Results System (PRS).