We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Current resources in Europe are too limited to ensure the new regulatory regime will be successfully implemented within the desired timeframes, according to MedTech. Read More
Foundation Medicine’s F1CDx can detect mutations in as much as 324 genes and two genomic signatures by sequencing DNA in solid tumor samples in a single test. Read More
The guidance covers the use of recognized standards, drug-device combination products, investigator-sponsored investigational testing, and stages of product development. Read More
The new guidance provides details on the clinical trial data needed to assess safety and efficacy of medical devices and in vitro diagnostics intended for registration in China. Read More
The FDA is finalizing guidance that urges sponsors to minimize device design changes in generic drug delivery products, and outlines how differences could threaten substitutability. Read More
The company said the approval “forms the basis of the additional regulatory approval it will seek through the World Health Organization prequalification program.” Read More