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An FDA inspection of Polar Products’ device manufacturing plant in Stow, Ohio, found that the facility lacked proper design and other records and did not adequately evaluate incoming product or its suppliers.
The EU Medical Device Coordination Group (MDCG) has proposed a new definition of hybrid audits, suggesting that there should be at least one auditor in a facility premises — at some point — during an audit by a notified body, with off-site team members participating using information and communication technologies.
The FDA has approved new safety labeling for Endologix’s AFX2 endovascular graft systems, which is used to treat patients with abdominal aortic aneurysm (AAA).
Logistics such as making sure only the right personnel have access to documents and that those documents can be copied, printed or scanned may seem basic but they are critical to a successful FDA inspection, says David L. Chesney, principal of DL Chesney Consulting. Read More
In another class action lawsuit involving generic EpiPens, two individuals and a health insurer have filed against Teva Pharmaceutical for allegedly making a deal with Viatris for Teva to delay marketing of its generic EpiPen in exchange for Viatris holding off marketing its generic narcolepsy competitor to Teva’s Nuvigil. Read More
The FDA should take a page out of one online retail giant’s book, says Commissioner Robert Califf, as it works to update its technology infrastructure and make its processes and interactions with industry as efficient as possible. Read More
Data from a post-approval study supported an updated indication for patients “without the presence of profound shock, end organ failure or acute neurologic injury,” the agency said. Read More
Results from a clinical trial showed a 62 percent reduction in physician misses of aortic calcification and a 33 percent reduction in misses of dilated aortas, the company said. Read More