On July 14, the FDA issued a new draft guidance concerning in vitro companion diagnostic devices (“IVD companion diagnostic devices”). As explained in its press release, such IVD companion diagnostic devices are already in use to identify patients that are most likely to benefit from certain therapeutic products, such as some monoclonal antibodies.
Please see full article below for more information.
Firefox recommends the PDF Plugin for Mac OS X for viewing PDF documents in your browser.
We can also show you Legal Updates using the Google Viewer; however, you will need to be logged into Google Docs to view them.
Please choose one of the above to proceed!
LOADING PDF: If there are any problems, click here to download the file.