Defying labels

Companion diagnostics debate: Drug labels will determine commercial opportunity

Comments on FDA's companion diagnostics draft guidance boil the debate down to who will have more control over which tests are used: companies or pathologists. If FDA requires inclusion of specific tests on labels, drug developers likely will be in the driver's seat. If the agency simply directs that tests provide certain kinds of data, it will be far easier for clinical laboratories to develop competitive tests.

When FDA issued its draft guidance in July, it was meant to facilitate the development and approval of drugs with companion diagnostics, as well as relieve companies of the burden of coordinating the agency's drug and device centers (see

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