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# Optical Imaging Drug Development Guidance
- URL: https://www.fdaweb.com/optical-imaging-drug-development-guidance/
- Published: 2025-01-07T12:00:00.000Z
- Updated: 2026-09-14T14:50:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158441

FDA has published a draft guidance, *Developing Drugs for Optical Imaging*, with recommendations for sponsors about clinical trial design features that support the development and approval of optical imaging drugs that are used in conjunction with imaging devices and intended as intraoperative aids for the detection of pathology such as tumors or to enhance the conspicuity of normal anatomical structures. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/developing-drugs-optical-imaging?ref=fdaweb.com) focuses on using optical imaging for the detection of tumors, lymph node staging, and enhanced delineation of normal anatomy to decrease the risk of injury.