FDA’s Upcoming Drug/Diagnostic Co-Development Guidance Could Quickly Become Outdated
This article was originally published in The Gray Sheet
Tests that look for many markers at a time “may completely change” the paradigm for companion diagnostics, CDRH’s Elizabeth Mansfield says.
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FDA makes very few revisions from its three-year-old draft, but simultaneously releases the much-delayed proposal to begin actively regulating lab-developed tests, which presents important underlying questions for personalized medicine.
FDA has finalized its guidance on companion diagnostics with very few revisions from the draft it released three years ago. But the final guidance was released simultaneously with FDA’s much-delayed proposal to begin actively regulating lab-developed tests, which presents important underlying questions for companion diagnostic policy.
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