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FDA Extends Comment Phase for Companion IVD Guidance

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has extended by a month the period during which it will accept public comments on its recent draft guidance outlining its planned policy for accepting and reviewing applications for companion diagnostic devices.

FDA said in a Federal Register posting Friday that it will accept public responses to the "In Vitro Companion Diagnostic Devices" draft guidance for industry and FDA staff, which it released in mid-July, through Oct. 12.

The guidance is aimed at drug developers who are developing a therapeutic that depends on the use of and IVD companion test, and for those developing companion tests that are intended to be used with a corresponding therapeutic product.

FDA said in the guidance that it expects that these companies will file applications on the drug and the test concurrently.

"The rationale of the guidance was to let people know before we approved these kinds of drugs – where you actually have to select the population with a test – that we need to know that the test actually works," Elizabeth Mansfield, FDA Director of Personalized Medicine Staff in the Center for Devices and Radiological Health, told GenomeWeb Daily News when the guidance was released. "The way we've been handling it so far is that we're using the two different regulatory mechanisms as they already exist."

She added, "We don't require the device company to do a whole separate trial. We're using the same regulatory pathways as ever, we're just able to tell the different companies what parts of it they need to fulfill, and what parts, if any" they don't.

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