The Regulation of Companion Diagnostics: Current Status and Updates
Companion diagnostics for personalized medicine is the most important emerging trend in the IVD industry today. In July, FDA released its draft guidance document regarding companion diagnostics, which offers the agency's current thinking on this area. In an effort to provide further clarity on this matter, the editors of IVD Technology have put together a special Webcast on the regulation of companion diagnostics.
China used to be called the sleeping giant. Anyone who follows the IVD space knows that the giant has awoken and is climbing down the beanstalk, hungry for market share. China is gradually becoming a competitive force and...
Any IVD device can and will fail under certain circumstances. CLSI EP 23 helps labs to manage and mitigate risk. Manufacturers also stand to benefit from knowledge of the guidelines.