The Food and Drug Administration (FDA) has announced the release of draft guidance titled "Developing Drugs for Optical Imaging." This guidance aims to provide advice to drug sponsors on designing clinical trials to develop and approve optical imaging drugs used with imaging devices during surgeries. Optical imaging drugs help surgeons identify tumors and differentiate them from normal tissue, enhancing surgical safety and effectiveness. Public comments on the draft can be submitted until April 8, 2025, although feedback is welcomed anytime.
Simple Explanation
The FDA made a new guide to help companies create special medicine that makes it easier for doctors to see things inside the body during surgery, like finding hidden lumps or normal body parts, using bright lights. People can tell the FDA what they think about this guide until April 2025.