Gutman Explains Goal of Theranostics Draft Being Co-Written by OIVD, CDER | GenomeWeb

Describing the current regulatory environment as a “unique window of opportunity” for diagnostic-therapeutic companion products, Steven Gutman, director of the US Food and Drug Administration’s Office of In Vitro Diagnostics, said an upcoming draft guidance on these so-called theranostics is a “high priority” at the agency.

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