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This excerpt is from the management report titled “Using Real-World Evidence in Drug and Device Submissions,” based on a webinar from FDAnews, A WCG Company. The presenters were Kristin Zielinski Duggan and Sally Gu of the Washington, D.C., law firm Hogan Lovells. Read More
This edition of Quick Notes features FDA’s approval of implantation of Medtronic’s neurostimulators for deep brain stimulation in sleeping patients, a De Novo clearance for SoClean’s bacterial reduction system for CPAP hoses and masks, an expanded clearance for Guard Medical’s orthopedic surgical dressing, and an update on Tandem Diabetes Care’s insulin pump app for Apple iOS devices. Read More
The Biden Administration has announced up to $150 million in Advanced Research Projects Agency for Health (ARPA-H) awards to develop technologies that will allow surgeons to provide more successful tumor-removal surgeries. Read More
In recalls the FDA describes as the most serious type, Inari Medical is updating its directions for use of its ClotTriever XL catheter and Medline is warning against use of the syringes included in several of its convenience kits. Read More
During the second session of the 118th Congress, FDAnews will track important pending legislation, that has been acted on by Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More
This edition of Quick Notes features announcements of Baxter’s agreement to sell its Vantive Kidney care segment, Merck’s B-Cell depletion therapy acquisition, Triastek collaboration with BioNTech and Crown Laboratories and Revance Merger. Read More
Debfitech has issued an urgent medical device safety removal letter to its customers of the RMU-2000 ARM XR chest compression device, which provides chest compressions on adults whose hearts suddenly stop, directing that the device be removed from use. Read More
This week, the FDA published final guidance on product-specific guidance meetings between FDA and ANDA applicants and an electronic submission template for medical device de novo requests. Draft guidance was published on change control plans for medical devices and product-specific guidances. Read More
In this edition of Quick Notes EU, we note a revised EMA guideline on pharmacovigilance, a call by EMA to revoke authorization of Ocaliva for treatment of primary biliary cholangitis — an autoimmune disease that destroys the liver’s bile ducts, a European Commission survey on electronic instructions for use for medical devices, a new pilot program for developers of orphan medical devices, and a thumbs down in the UK for Enhertu for treatment of HER2-low breast cancer by the National Health Service. Read More
Globus Medical, a manufacturer of surgical robots, received an FDA Warning Letter after the company’s inadequate response failed to address findings regarding screws misplaced during surgeries, lack of correction and preventive action (CAPA) plans and failure to file medical device reports (MDR). Read More
The FDA outlines what goes into a De Novo device request filed using the electronic Submission Template and Resource (eSTAR), in a final guidance released Thursday. Read More
ICU Medical is updating the use instructions for the Plum 360, Plum A+ and Plum A+3 Infusion Systems due to a manufacturing defect of the batteries, which can substantially diminish the life of the batteries and could put patients at risk. Read More