FDA Issues Draft Guidance for Development of Personalized Medicine Diagnostics

July 21, 2011 10:49 am

FDA published a draft guidance to facilitate the development and review of companion diagnostics used to help health care providers determine appropriate drug therapies for individual patients. The guidance provides information on FDA policy for reviewing companion diagnostics and corresponding therapies. FDA explains that the guidelines are aimed to support the development of new targeted medicines and their corresponding diagnostics. As noted in an FDA news release, the guidance includes clarification of the FDA definition of a companion diagnostic, recommends that manufacturers engage early with FDA regarding development plans, and explains FDA’s process for conducting simultaneous review of therapies and their corresponding companion diagnostics. Public comments on the draft guidance must be received within 60 days of July 14, 2011, and should be submitted online at regulations.gov using docket number FDA-2011-D-0215-0002, or in writing to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.