Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination

On April 16, 2018, the Food and Drug Administration issued a draft guidance, “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination,” to describe for sponsors of certain oncology trials an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic (IVD) in a trial of investigational cancer drug or biological products is considered significant risk, non-significant risk, or exempt from further pre-market review.

This guidance will be open for public comment until June 15, 2018. The FDA Oncology Center of Excellence welcomes comments from the oncology community about this draft guidance. Submit comments to the Federal eRulemaking Portal at https://www.regulations.gov citing the Docket No. FDA-2018-D-0944 for “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Draft Guidance for Industry; Availability.” To submit comments by mail, follow instructions in the Federal Register Notice.

The draft guidance outlines criteria under which sponsors may include information about an investigational IVD in the Investigational New Drug (IND) application submission to the FDA center responsible for the therapeutic product (Center for Drug Evaluation and Research [CDER] or Center for Biologics Evaluation and Research [CBER]). This would allow the pre-market information related to the investigational drug and the investigational IVD to be contained in a single IND application. Currently, separate applications are required for the therapeutic product and the IVD.

Consolidating the information about the investigational drug and device into the same application enables more efficient review and assist in establishing the scientific relationship between the drug and the diagnostic used to select patients. CDER or CBER would then coordinate with the FDA’s Center for Devices and Radiological Health to determine whether use of the investigational IVD in the trial is considered significant risk, non-significant risk, or exempt.

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