FDA warns Acceleron of possible fines for not posting results from failed trial
In a first for the FDA, the agency on Wednesday said that it sent a notice of noncompliance to Acceleron Pharma for its failure to post results from a cancer trial, and said the company has 30 days to correct this failure or it may have to pay a $10,000 penalty or face criminal prosecution.
The letter opens a big can of worms for biopharma companies, which have a legal responsibility to post trial results to the government’s database at ClinicalTrials.gov, generally no later than one year after the study’s completion date unless a deadline extension is obtained. But many companies, even if they’re transparent about the results, fail to update the listings in the database.
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