POLICY ALERT: FDA seeks comment on proposed policy for diagnostic tests used with targeted drug therapies

July 12, 2011

Part of agency’s efforts to promote development of personalized medicines and diagnostics

The U.S. Food and Drug Administration today issued a new draft guidance to facilitate the development and review of companion diagnostics – tests used to help health care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft document is intended to provide companies with guidance on the agency’s policy for reviewing a companion diagnostic and the corresponding therapy.

“These proposed guidelines support the development of innovative new targeted medicines and their corresponding diagnostic tests and are intended to provide manufacturers with greater predictability,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “It is the agency’s goal to help stimulate early collaborations between drug and device makers so they can develop the best medical products for treating patients.”

The FDA is seeking public input on the draft guidance for 60 days.

For more information, please visit FDA's web site at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm262632.htm.


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