Drugs

Codevelopment In Vitro Guidance Out

FDA has issued a draft guidance, Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product, as a “how-to” supplement to an earlier final guidance that defined in vitro companion diagnostic (IVD) devices and set an expectation that companion diagnostics and corresponding therapeutic products should be approved or cleared by the agency at the same time. The new draft provides general principles for addressing issues that may arise when codeveloping a therapeutic product and a corresponding IVD companion diagnostic. It also gives considerations for planning and executing clinical trials and successfully fulfilling FDA regulatory requirements.

Contents of the guidance include regulation of investigational IVDs and therapeutic products, planning ahead for IVD validation in potential codevelopment programs, therapeutic product clinical trial design considerations, considerations for IVD development in late therapeutic product development, planning for contemporaneous market authorizations, labeling considerations, and postmarketing considerations.

“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 nevertheless beneficial for therapeutic product development or clinical decision making,” the document says. “Likewise, the principle 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).”

FDA will hold an 8/18 webinar to share information and answer questions about the draft guidance. Information about it is available here. The agency will accept comments on the draft for 90 days following publication in the Federal Register.

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