In a first, FDA cites violation of clinical trials reporting law

In a first, FDA cites violation of clinical trials reporting law

3 years ago
Anonymous $f-b3Pf4iLZ

http://www.sciencemag.org/news/2021/04/first-fda-cites-violation-clinical-trials-reporting-law

The Food and Drug Adminstration has for the first time warned a sponsor of a clinical trial that it had failed to follow a law requiring the posting online of the data from the study.

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.gov. The action was leveled against the Cambridge, Massachusetts-based drug company Acceleron for its failure to provide data from a completed trial of its experimental drug to treat kidney cancer.