FDA Finalizes Policy on Use, Approval of Companion Diagnostics

July 31, 2014 5:51 PM

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FDA Finalizes Policy on Use, Approval of Companion Diagnostics

The US Food and Drug Administration (FDA) has released a long-sought draft guidance document on in vitro diagnostic (IVD) companion diagnostic (CDx) products—products intended to help guide the therapeutic use of new medicines based on a consumer's genetic characteristics.

Regulators and industry have both been touting the benefits of companion diagnostics in recent years as the products have become, in the words of FDA, "more common."

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