FDA has issued a draft guidance, “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination,” to describe for sponsors of certain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 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, which is posted here, will be open for public comment until June 15.
The draft guidance outlines criteria under which sponsors may include information about an investigational IVD in the Investigational New Drug application submission to the FDA center responsible for the therapeutic product (Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research).
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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