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An FDA investigator handed Lincotek Medical a Form 483 for inadequate corrective and preventive action (CAPA) and validation procedures after an inspection last November of the company’s facility in Vandalia, Ohio. Read More
Efforts to improve diversity in clinical research can be greatly improved when sponsors take a hard look at their current practices and protocols, work directly with sites and consider adding sites well-suited for the task, a new report from the Advanced Medical Technology Association (AdvaMed) advises. Read More
Verily Life Sciences’ investigational smartwatch has shown potential for monitoring Parkinson’s disease in home settings in a multiyear European study. Read More
A proposed in vitro clinical test (IVCT) reform bill that may end up in the fifth iteration of the Medical Device User Fee Act (MDUFA) is generating pushback from industry groups and academia. Read More
The FDA smacked Louisville, Ky.-based devicemaker Vivorte with a Form 483 over sterilization lapses observed during an inspection conducted from Nov. 15 to 23, 2021. Read More