FDA Companion Diagnostic Road Map Critical Tool, Clarity Sought

Thursday, October 20, 2016

Source: Bloomberg BNA

Industry groups generally hailed the FDA’s proposed road map for developing companion diagnostics but questioned the feasibility of avoiding their use for clinical trial prescreening.

The Food and Drug Administration’s draft guidance, Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product, drew 15 online comments, primarily from drug and device companies or their trade groups. The draft guidance directs industry sponsors through the process of developing a drug or biologic with a companion device so the agency can approve both at the same time. Companion in vitro diagnostics (IVDs) are considered a critical tool to advance the White House priority of precision medicine.

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