Right now, writes Amy Miller at the Personalized Medicine Coalition's blog, drugs are regulated by one part of FDA, lab kits by another, and lab services by the Center for Medicare and Medicaid Services. "Companion diagnostics (lab tests and kits designed inform drug selection or dosage) pose a challenge to this system, and the opportunity to create a better one," she adds. And PMC has some ideas. Miller says that the general themes of the group's recommendations to FDA include the recognition of the different types of companion products in the regulatory process, developing oversight of the regulatory process in an open way, and ensuring hat the policies encourage "rapid access to new diagnostic information."
Dec 17, 2009