CENTRO DI DOCUMENTAZIONE SUI DISPOSITIVI MEDICI

ISO - Original publisher By  Barnaby   Lewis The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation. ISO 13485,  Medical devices — Quality management systems — Requirements for regulatory purposes , is the International Standard for quality management systems for the medical devices sector. Published in 2016, it is designed to work with other management systems in a way that is efficient and transparent. The standard, which is now in its third edition, received strong support from the FDA, in line with its drive for global convergence of medical device regulatory processes. GO TO COMPLETE ARTICLE> CLICK HERE ( link authorized by ISO)

From Website Posted 32 January 2017 By  Zachary Brennan "In a sign of what’s to come for the US Food and Drug Administration (FDA), President Donald Trump told pharmaceutical company CEOs Tuesday that his administration will be “cutting regulations at a level no one has ever seen before.” The comments, which came before the meeting with CEOs from industry group PhRMA, Merck, Novartis, Johnson & Johnson, Celgene and others, Trump said in terms of the drug approval process: “We’re also going to be streamlining the process, so that from your standpoint, when you have a drug you can actually get it approved, instead of waiting for many, many years." He also called for significantly lower drug prices and  again  for better negotiations on drug prices between Medicare and companies. “We’re going to get the approval process much faster,” he repeated, noting that “one thing that’s always disturbed me is that you come up with a new drug for a pa...