Cybersecurity for Medical Devices risks and vulnerabilities

Why MD Cybersecurity is so important

Why MD Cybersecurity is so important? PQE Group – 3/12/2019 The hidden risks of a disruptive innovation. Is Cybersecurity important for Medical Devices? The answer is absolutely yes. But let’s move a bit backwards, to understand the reason why nowadays Cybersecurity has become a main concern for all Medical Devices producers. It’s well renowned that […]

FDA temporarily retreating on impurities for market shortage

FDA temporarily raising tolerance on impurities due to market shortage

FDA has issued setting temporary rules on a probable cancer-causing impurity formerly regulated. To avoid market shortage of Losartan, drugmakers will be able to make losartan with an impurity percentage above its prescribed level for six months while the supply of clean drugs is ramped up. A calculated risk, to preserve blood pressure drugs availability […]

OIL is a medicine for FDA

Olive oil is a medicine according to FDA

Yes it is! Recently the U.S. Food and Drug Administration (FDA) has determined that there is credible evidence to support a qualified health claim that consuming oleic acid in edible oils, such as olive oil, sunflower oil, or canola oil, may reduce the risk of coronary heart disease. For this reason FDA decided to exercise […]