FDA issues draft guidance on companion diagnostics
FDA released draft guidance on the development of in vitro companion diagnostics. The document clarifies FDA's definition of a companion diagnostic, reiterates the agency's intention to conduct simultaneous reviews of a product with its companion diagnostic, and identifies situations where the agency may approve a targeted product in the absence of an approved companion diagnostic. However, the guidance does not address the design or conduct of clinical trials of products in combination with companion diagnostics.
FDA defines a companion diagnostic as a device that provides information essential for the safe and effective use of a corresponding therapeutic. The agency added that the definition does not include clinical laboratory tests intended to provide "useful" information where that information is not a determining factor in the safe and effective use of a therapeutic. ...