AMP Expresses Concerns About Product Labeling in Letter to FDA

The Association for Molecular Pathology (AMP) has requested that the Food and Drug Administration (FDA) prohibit the inclusion of patient management instructions or other medical recommendations in the product labeling for in vitro diagnostic tests. In a May 13 letter to Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health,…