FDAnews Device Daily Bulletin

Guidance Maps Out Codevelopment Pathways for Companion Diagnostics, Drugs

July 20, 2016

In yet another move toward precision medicine, the FDA is mapping out codevelopment pathways for companion diagnostic devices to accompany targeted therapies.

Underscoring the complexity of developing intertwined products, the FDA’s draft guidance released July 15 recommends that companies develop them in tandem because the agency supports simultaneous approval and because it could hasten approval. The agency recommends that sponsors of both the IVD and the therapeutic product meet with the appropriate FDA centers prior to launching a trial.

The guidance describes general principles to guide codevelopment of therapies and their companion diagnostics, regulatory requirements that sponsors should be aware of, and considerations for planning clinical trials.

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