Woodcock, Gutman Plan Theranostics Guidance; Seek to Marry Dx, Tx Data | GenomeWeb

The head of the FDA’s Center for Drug Evaluation and Research and the director of the agency’s Office of In Vitro Diagnostics are currently co-writing a new draft guidance describing the use of jointly marketed diagnostic-therapeutic products, SNPtech Pharmacogenomics Reporter has learned.

This development, which follows the release of two related draft documents, is aimed at meeting head-on the rise of so-called theranostic products, and helping the agency further clear the regulatory path to pharmacogenomics.

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