FDA Publishes Draft Guidance for Diagnostic Tests Used with Targeted Drug Therapies

On July 14, 2011, the U.S. Food and Drug Administration (FDA) issued a new draft guidance to facilitate the development and review of companion diagnostics tests designed to be used by healthcare professionals to select the appropriate patient for a particular therapy or to optimize a dosing regimen. Given that the diagnostic device is “essential” to the safe and effective use of a particular therapeutic product, and that the device will be included in the therapeutic product’s labeling, the FDA does not expect, as a general rule, to approve such therapeutic product applications unless the device is also approved.

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