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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
Brisbane, Calif.-based Cutera, a manufacturer of medical aesthetic and dermatology devices, was hit with an FDA warning letter for a still-functioning website for a vaginal rejuvenation product the company removed from the market in 2019. Read More
The FDA has approved updated labeling of Abiomed’s Impella RP system to better characterize the type of patients who may benefit most from using the heart pump. Read More
How to tell whether clinical decision support (CDS) software is exempt from classification as a medical device was the focus of a webinar last week sponsored by the Food and Drug Law Institute. Read More