Home » Dx, Drug Makers Call for More Detail in Companion IVD Guidance
Dx, Drug Makers Call for More Detail in Companion IVD Guidance
August 2, 2011
Device companies and drugmakers will need to work closely and quickly to ensure novel therapeutic products and their companion in vitro diagnostic (Dx) devices are ready for U.S. Food and Drug Administration (FDA) review at the same time, a draft guidance says.
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