In a First, FDA Cites Violation of Clinical Trials Reporting Law

April 29, 2021

(Science) – In an unprecedented enforcement action, the Food and Drug Administration (FDA) yesterday informed a clinical trial sponsor that it had violated the law requiring that results from human studies of medical treatments and devices be posted to the federal repository ClinicalTrials[dot]gov. The action was leveled against the Cambridge, Massachusetts–based drug company Acceleron Pharma for its failure to provide data from a completed trial of its experimental drug to treat kidney cancer.