A new final guidance from the FDA allows some sponsors of oncology products to file a single application for use of an investigational diagnostic in their trial rather than filing for the drug and device components separately.
Under the new guidance, sponsors of trials combining a new oncology drug with a new in vitro diagnostic (IVD) device will submit an investigational new drug application to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER), including information about the investigational IVD in question.
CDER or CBER then will consult with the Center for Devices and Radiologic Health (CDRH) to determine whether the IVD presents a “significant risk” and requires the sponsor to submit to CDRH a separate application for investigational device exemption.
The guidance applies only to new IND applications and does not address IND-exempt trials.
Read the final guidance here: www.fdanews.com/10-10-19-IVDGuidance.pdf.