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FDA’s Upcoming Drug/Diagnostic Co-Development Guidance Could Quickly Become Outdated

Tests that look for many markers at a time “may completely change” the paradigm for companion diagnostics, CDRH’s Elizabeth Mansfield says.

FDA is almost done writing a draft guidance on how to co-develop a companion diagnostic for a drug, but the document could essentially be outdated as soon as it is released.

The co-development draft guidance will address the types of issues drug and diagnostics firms should consider as they develop paired products, such as when tests should be incorporated into clinical...

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