September 26, 2019

FDA, M-CERSI Seek Radiology Participation in Sulfan Blue Survey

The Food and Drug Administration (FDA), through the University of Maryland-Center of Excellence in Regulatory Science and Innovation (M-CERSI), is seeking anonymous participation from radiologists, nuclear medicine physicians and other clinicians to better understand how sulfan blue is used in clinical practice.

Sulfan blue has been used in sentinel lymph node biopsy and removal, but a demonstrated clinical need for the agent is required before it can be included on the FDA’s 503B Bulks List. Outsourcing facilities can only compound sulfan blue using a bulk drug substance if it qualifies to appear on that list.

The FDA has two cooperative agreements with research partners to help inform the agency’s evaluation of the nominated substances. M-CERSI, one of the FDA’s cooperative agreement holders, is conducting research to better understand how sulfan blue is used in clinical practice. Survey responses will inform the FDA’s decision about whether to include it on the 503B Bulks List. You can help answer this question by taking a short survey.