FDA Official Offers Advice on Regulatory Path for Companion Diagnostics | GenomeWeb

Originally published Sept. 20.

By Turna Ray

Arlington, Va. — An official from the US Food and Drug Administration last week demonstrated that the agency is making progress on issuing formal guidelines on the codevelopment of drug and diagnostic personalized medicine products by discussing detailed strategies for navigating the regulatory process for Rx/Dx combination products at an industry conference.

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