More US FDA Enforcement Of Clinical Trial Reporting Is Expected After Acceleron’s ‘Clerical Oversight’

‘Vast majority’ of 40 parties who received pre-notices of non-compliance with reporting requirements took action, FDA says. First noncompliance letter to Acceleron has prompted speedy response from sponsors.

clinicaltrials.gov — Acceleron is the first company cited for failure to report trial results on ClinicalTrials.gov • Source: Alamy

Following several studies on unreported clinical trial results and a court ruling on the issue, the US Food and Drug Administration recently took its first enforcement action against a sponsor for failing to post its data on ClinicalTrials.gov. The move is compelling companies to respond to queries from the agency about missing data and is expected to result in more enforcement actions.

The FDA issued its first notice of noncompliance with clinical trial reporting requirements to Acceleron Pharma, Inc. The action...