FDA's Rx/Dx Draft Guidance Urges Simultaneous Development, but Addresses Alternative Scenarios
July 13, 2011
FDA's Rx/Dx Draft Guidance Urges Simultaneous Development, but Addresses Alternative Scenarios
A new FDA draft guidance lays out the agency's thinking on what constitutes a companion diagnostic, as well as Rx/Dx situations in which it would accommodate the marketing of unapproved tests.
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