On July 31, 2014, FDA issued its final guidance on the development, review, and approval or clearance of companion diagnostics, tests used to identify which patients will likely benefit or be harmed by treatment with a certain drug. Companion diagnostic tests are intended to aid physicians in selecting appropriate therapies for individual patients and are commonly used to detect certain types of gene-based cancers. The finalized guidance is intended to help companies identify the need for companion diagnostics during the earliest stages of drug development and to plan for the development of a companion test at that time. The ultimate goal of the guidance is to stimulate early collaborations.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
