On July 14, 2011, FDA issued a new draft guidance titled “In Vitro Companion Diagnostic Devices.”  This draft guidance is intended to shed light on the agency’s policy for reviewing a companion diagnostic tests and the corresponding therapy.  FDA intends for the guidance to assist sponsors in developing a safe and effective therapeutic product that relies on an in vitro companion diagnostic device.  Companion diagnostic tests addressed by this draft guidance are the tests used to help healthcare professionals determine whether a patient should be given a particular drug therapy and how much of the therapy to give that particular patient.  FDA issued this draft guidance due to the rise of therapeutic products that use diagnostic tests to meet their labeled safety and effectiveness claims.  According to Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health (CDRH) stated, “It is the agency’s goal to help stimulate early collaborations between drug and device makers so they can develop the best medicinal products for treating patients.”

FDA is accepting public comments up until September 12, 2011.  Comments can be submitted online at http://www.regulations.gov/ identifying the  docket number listed in the notice of availability that published in the Federal Register (Docket No. FDA-2011-D-0215) or in writing to:

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Rm. 1061

Rockville, MD 20852