Drug/Diagnostic Co-Development Guidance Coming Soon, But Could Be Outdated Quickly
This article was originally published in Pharmaceutical Approvals Monthly
Tests that look for many markers at one time “may completely change” the paradigm for companion diagnostics, CDRH’s Elizabeth Mansfield says.
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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.
FDA's draft guidance on the development of companion diagnostics for drug therapies, released July 12, delivers on a promise to publicly outline how it will address review of those products, but at only 12 pages, it has left some in industry longing for more insight.