FDA's Rx/Dx Draft Guidance Urges Simultaneous Development, but Addresses Alternative Scenarios | GenomeWeb

By Turna Ray

A long-awaited
draft guidance issued by the US Food and Drug Administration this week clarifies which in vitro diagnostics fall into the agency's definition of a companion test and outlines various drug/diagnostic codevelopment scenarios in which the agency would allow sponsors to market tests that don't have 510(k) clearance or premarket approval.

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