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Our coverage spans relief from third party funded mass tort litigation sought by the medical device industry to Apple prevailing in Masimo patent appeal and two class I device recalls. Read More
Upcoming events in the coming weeks include eight FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on calculating sample sizes for verification and validation activities, medical device counterfeiting and what to expect from the FDA in 2024. Read More
Our coverage spans an Adcomm decision on use of phenylephrine, 1Health.io FTC order for failure to protect privacy and security, user fees for OTC monograph order requests and a GDUFA report available. Read More
Failure modes and effects analysis (FMEA) is a useful tool for medical devicemakers but it is no substitute for a risk assessment, said quality expert Eliot Zaiken in an Aug. 24 webinar from FDAnews, a WCG company. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
Royal Philips, Amsterdam-based parent company of Philips Respironics, reports that it’s close to settling multiple lawsuits related to Philips Respironics’ voluntary recall of certain sleep and respiratory care devices. Estimated amount: $616 million. Read More
Our coverage spans an Abbott acquisition, FDA draft guidances on endogenous Cushing’s syndrome and peptide drug development, EMA guideline revision on clinical trials for depression treatments and a GAO report on drug rebates in Medicare part D. Read More