FDA Proposes Guidelines For Targeted Drug Therapies

Law360, New York (July 13, 2011, 7:21 PM EDT) -- The U.S. Food and Drug Administration proposed guidelines Tuesday for targeted therapies that would, in most cases, require simultaneous review of the therapies and their corresponding diagnostic devices, which aim to predict whether a certain medicine would work for a patient.

Those tools, called in vitro companion diagnostic devices, typically determine whether patients have gene amplifications or protein over-expressions to predict the effectiveness of a treatment, such as a test approved to correspond to Genentech Inc.'s gene-targeting breast cancer drug Herceptin.

These devices can also monitor...
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