Clinical Pharmacology Corner: FDA Announces Availability of the Draft Codevelopment Guidance

FDA Announces Availability of the Draft Guidance, “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product”

On July 15, 2016, the U.S. Food and Drug Administration (FDA) announced the availability of the draft guidance entitled “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.” This guidance is intended to be a practical guide to assist therapeutic product sponsors and in vitro diagnostic device (IVD) sponsors in developing a therapeutic product with an accompanying IVD companion diagnostic, a process referred to as codevelopment. This guidance is also intended to assist FDA staff participating in the review of such IVD companion diagnostics or their associated therapeutic products.

Codevelopment of IVD companion diagnostics and therapeutic products is critical to the advancement of precision medicine. FDA seeks to facilitate innovations in precision medicine by providing sponsors with a set of principles that may be helpful for effective codevelopment and in fulfilling FDA’s applicable regulatory requirements. This guidance outlines fundamental principles that have been developed to assist sponsors in codevelopment.

An IVD companion diagnostic is an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product. As described in the FDA guidance entitled “In Vitro Companion Diagnostic Devices,” in most circumstances, an IVD companion diagnostic should be approved, granted a de novo request, or cleared by FDA contemporaneously with the approval of the corresponding therapeutic product for the use indicated in the therapeutic product labeling.

This codevelopment guidance describes:

• general principles to guide codevelopment to support obtaining contemporaneous marketing authorization for a therapeutic product and its corresponding IVD companion diagnostic
• certain regulatory requirements that sponsors should be aware of as they develop such products
• considerations for planning and executing a therapeutic product clinical trial that also includes the investigation of an IVD companion diagnostic
• administrative issues in the submission process for the therapeutic product and the IVD companion diagnostic

Although this guidance focuses on IVD companion diagnostics, many of the principles discussed may also be relevant to the codevelopment of therapeutic products with IVDs that do not meet the definition of an IVD companion diagnostic but that are nonetheless beneficial for therapeutic product development or clinical decision making. Likewise, the principles discussed in this guidance may be useful even if codevelopment is not planned from the start of a therapeutic product’s development (e.g., the potential benefit of an IVD is not established until later in the therapeutic product’s development lifecycle).

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The draft codevelopment guidance is available at http://go.usa.gov/xaQeY.

The “In Vitro Companion Diagnostic Devices” guidance is available at http://go.usa.gov/xaPEV.

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This burst was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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FDA/Center for Drug Evaluation and Research (CDER)
Office of Translational Sciences
Office of Clinical Pharmacology
Email: ocp@fda.hhs.gov