Who authorized the FDA to spy on some of its own employees and those with whom they may have communicated? The culprit appears to have been the FDA Office of Chief Counsel, according to US Senator Chuck Grassley, who made the disclosure in a scathing letter to FDA commish Margaret …
The European Medicines Agency is investigating whether Roche failed to report tens of thousands of adverse events in connection with its various drugs, including 15,161 patients deaths. The probe comes after UK regulators identified deficiencies in reporting adverse events after conducting recently review procedures and was actually part of a …
The FDA has two systems for alerting physicians to product recalls, yet 20 percent of recalls for Class I products – which are the likeliest to cause patient harm – were not communicated through either system between 2004 and 2011, according to an analysis published in the Archives of Internal Medicine. The …