Nitrosamines RA evaluation deadline extended due to coronavirus spreading
European Medicines Regulatory Network agreed to proceed with the extension of the Step 1 (risk evaluation) deadline to October 1st, 2020, due to Covid-19 spreading.
Tag: FDA
Why MD Cybersecurity is so important
Why MD Cybersecurity is so important by Danilo Maruccia, Executive Consultant & Business Partner – PQE Group 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.
PDA-FDA Joint Regulatory Conference 2019
Washington DC (USA) ● Sept 16th-18th, 2019
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 […]
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 […]