Cross posted from Nature’s The Great Beyond blog.
Drug giant Pfizer has been issued with an official warning letter by US regulators after “significant violations” resulted in overdoses being administered to several children enrolled in one of its clinical trials.
In a letter dated 9 April and released yesterday, the Food and Drug Administration says an investigation has found the company failed to properly oversee the trial. “As a result of inadequate monitoring, widespread overdosing of study subjects at multiple study sites was neither detected nor corrected in a timely manner,” the letter says.