The U.S. Food and Drug Administration (FDA) has issued draft guidance providing recommendations to drug companies on the design of clinical trials for optical imaging drugs used with imaging devices during medical procedures.
Such procedures are intended to aid in the detection of tumors or other pathology or to delineate normal anatomical structures, according to the FDA.
The FDA said that the guidance is necessary because of the burgeoning interest in the development of novel optical imaging drugs and imaging devices to assist standard surgical procedures in a variety of contexts. Increasing use of minimally invasive and robotic surgical approaches is also a factor, specifically optical imaging during oncologic surgery, the agency noted.
The FDA is taking comments on the guidance through April 8, 2025.