PMC Asks FDA to Issue New Guidance Reflecting Rapidly Evolving Rx/Dx Co-development Landscape | GenomeWeb

By Turna Ray

Drug/diagnostic co-development is not the ideal scenario presented by the US Food and Drug Administration's 2005 concept paper, which describes regulatory and evidentiary guidelines for the simultaneous development of a single test in conjunction with a single drug, a white paper issued by the Personalized Medicine Coalition this week asserts.

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