Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products

December 6, 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 labeling of the test often reflects the use of that diagnostic in conjunction with just one drug. And, in turn, the drug can reflect the … (leggi tutto)