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Latest From Fresenius Medical Care North America
The Quality Lowdown: Moderna, Novartis, Dr. Reddys Confront Challenges
Leading edge products like mRNA vaccines and CAR-T therapies are not immune from quality problems, nor are immunosuppressives, as US FDA inspections and internal investigations recently found.
News We’re Watching: More Class I Recalls, FDA Expands TAP, Guardant Appeals Patent Verdict, And More
This week, the US FDA labelled several recalls class I, approved an at-home diagnostic for chlamydia and gonorrhea, and announced the expansion of its TAP pilot program. Guardant Health also announced it would appeal a verdict in a patent suit against the company and AdvaMed voiced its continued support for pending breakthrough device legislation.
Toxins In Silicone Tubing Leads To FDA Warning About Hemodialysis Machines Made By Fresenius
Toxins that have been shown to cause adverse events in animals – including endocrine dysfunction and male reproductive effects – are emitted by tubing that’s part of Fresenius’ 2008T, 2008K2 and 2008K model devices, the US agency says in a letter to health care providers.
The Post-COVID Mantra For Medtechs: Prioritize, Optimize And Modernize
Medtech’s resilience and flexibility have been clear to see during the COVID-19 pandemic. In this forward-looking view for 2022, CEOs from some of the Top 50 global medtechs share their perspectives on the present and the future, from company and health care system standpoints.
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