Hoping that this guidance sets efficient and predictable regulatory pathways for those interested in developing optical imaging agents.
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Some newly issued guidance regarding Optical Imaging from the Food and Drug Administration. https://lnkd.in/emyNzjpB Sets forth practical recommendations for clinical trial design which should bode well for the Optical Imaging Agent, drug component development. It provides for an “Intrasubject Control Design” to get surgeons on board early and a “Parallel-Arm Control Design” to align all stakeholders. It is interesting to see references made to the successful radiotracer 99Tc tilmanocept for sentinel lymph node mapping in the context of developing optical imaging agents. Some other noteworthy points of clarity in the guidance include the delineation of anatomical structures and intraoperative fluorescence angiography. #FDA FDA #radiology #surgery #opticalimaging #contrastmedia #imagingagent #fluoresence #