FDA threatens drugmaker with fines for failing to report trial results

Acceleron Pharma became the first drugmaker to face potential fines from the US Food and Drug Administration (FDA) for failing to report clinical trial results to ClinicalTrials.gov.

In a notice of noncompliance sent to Acceleron on 27 April, FDA notified the Cambridge, MA-based drugmaker that it has 30 days to correct the issue or face up to $10,000 per day in civil monetary penalties or other regulatory action including injunction or criminal prosecution.