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It’s well-known that the National Institutes of Health (NIH) offers billions of dollars in grants to US academic research facilities. What’s less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the hopes of bringing new products to market.
The European Commission's regulatory committee on medical devices on 19 May voted in favor of the commission's decision that products "whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry extract, is to prevent or treat cystitis," also known as bladder inflammation or infection, "are not medical devices within the meaning of Article 1 (2) (a) of the Medical Devices Directive."
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
For the second time in seven months, the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) met in late April to discuss their approaches for evaluating antimicrobial agents, with the aim of identifying areas for convergence.
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The US Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Merck’s Keytruda (pembrolizumab) for patients whose cancers have a specific biomarker. View More
The US Food and Drug Administration (FDA) on Thursday kicked off a fortuitously-timed public workshop on medical device cybersecurity, the agency's third on the subject to date. View More
With ongoing work on guidance related to software as a medical device, and a new dedicated unit to digital health coming to the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), the agency is slowly but surely dipping its toe into the rapidly advancing field. View More
The US Food and Drug Administration (FDA) on Monday released details on the structure of its newly realigned Office of Regulatory Affairs (ORA). View More