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FDA Issues Final Guidance on IVD Reviews for Investigational Cancer Drug Trials

NEW YORK – The US Food and Drug Administration released its final guidance on Wednesday to streamline the process for reviewing in vitro diagnostic tests used in investigational cancer drug trials.

Typically, IVDs used in cancer drug trials required a submission to the FDA separate from the submission for the drug. Under the new guidance, companies can simultaneously submit for the cancer drug and the IVD for the clinical trial to determine whether the device is considered significant risk (SR), nonsignificant risk (NSR), or exempt from investigational device exemption (IDE) requirements.

Use of the new streamlined process is optional, though "FDA encourages sponsors to use the streamline process … when possible to reduce administrative burden on sponsors and FDA and to maintain the current level of regulatory approval," the agency said in its final guidance.

If the device is determined to be SR in the streamlined process, the FDA said, the cancer drug trial sponsor may need to submit an IDE either to the Center for Devices and Radiological Health or Center for Biologics Evaluation and Research, as well as an investigational new drug (IND) application.

The FDA also noted that if an invasive biopsy that may pose a serious risk to a clinical trial subject is required for investigational IVD testing for enrollment in the clinical trial, the trial is not eligible for the streamlined submission process.

Sponsors using the streamlined process should include a description of the IVD; how it will be used in the trial; a description of the population and information about what is known about the biomarker being investigated by the IVD; the specimen type being collected for investigational IVD testing; and other information.

Within the 30-day review time for the IND, the appropriate center will determine whether the IVD is SR, NSR, or exempt, FDA said.