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On August 18, the FDA hosted a webinar to share information and answer questions about the draft guidance “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.” This draft guidance, issued on July 14, is a “how-to” guide to supplement previously released final guidance “In Vitro Companion Diagnostic Devices,” which defined in vitro companion diagnostic devices (IVD companion diagnostics) and set the expectation that IVD companion diagnostics and corresponding therapeutic products should be approved or cleared by the FDA at the same time.

This draft guidance is intended to assist with the codevelopment of a therapeutic product and an accompanying IVD companion diagnostic. This guidance is also intended to assist FDA staff with reviewing companion diagnostics or their associated therapeutic products.

The guidance provides general principles for addressing issues that may arise when codeveloping a therapeutic product and a corresponding IVD companion diagnostic. It also provides considerations for planning and executing clinical trials and successfully fulfilling FDA regulatory requirements.

This guidance is part of the FDA’s efforts to facilitate innovation in precision medicine by assisting with the codevelopment of therapeutic products and companion diagnostics. We welcome comments regarding this draft guidance. The notice of availability published in the Federal Register and will be open for comments for 90 days from the publication date.