Posted by Michael Wonder on 06 Dec 2018
Statement from FDA Commissioner on the FDA’s new effort for developing and class labelling of in vitro companion diagnostics for classes of oncology therapeutic products
6 December 2018 - One challenge we face right now, when it comes to developing diagnostics that can help target the delivery of cancer drugs, is the way these diagnostics are sometimes labeled.
When an in vitro diagnostic test gets approved, it’s often based on the results of studies with one specific drug. As a consequence, the labelling of the test often reflects the use of that diagnostic in conjunction with just one drug. And, in turn, the drug can reflect the use of that medicine in conjunction with just one diagnostic test.
But this often isn’t the way medicine is practiced and the way patients receive care.
