Building on its existing policy regarding the labeling of companion diagnostics, the FDA issued a guidance discussing the development and labeling of in vitro companion diagnostics to support the use of multiple oncology drugs. “Trials designed to support approval of a specific therapeutic product and a specific companion diagnostic have led to companion diagnostic labels that reference only a specific therapeutic product(s). Such specificity in labeling can limit a potentially broader use of a companion diagnostic that may be scientifically appropriate,” according to the agency. The guidance discusses considerations for developing a companion diagnostic for labeling for use with a specific group of oncology products and for broadening the labeling of already approved or cleared companion diagnostics.

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