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Companion Diagnostics For Breakthrough Drugs Also Getting Swift Attention, FDA Says

Executive Summary

Device center officials cite a host of formal and informal actions available under existing legislative authority to ensure that development and review of companion diagnostics do not hinder the ability of FDA-designated breakthrough therapies from coming to market.

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Drug/Diagnostic Co-Development Guidance Coming Soon, But Could Be Outdated Quickly

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

Drug/Diagnostic Co-Development Guidance Coming Soon, But Could Be Outdated Quickly

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