FDA Approves System to Produce Medical Imaging Isotope in U.S.

The Food and Drug Administration today approved a domestic system for producing Technetium-99m, the most widely used radioisotope for nuclear medical imaging. The current Tc-99m production process requires shipping enriched uranium to other countries for irradiation, resulting in a complicated and uncertain supply chain. “Every day, tens of thousands of people in the U.S. undergo a nuclear medical imaging procedure that depends on Tc-99m,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This radioisotope is vital to disease detection, yet health care professionals have faced challenges with adequate supply due to a complex supply chain that sometimes resulted in shortages. Today’s approval has been the result of years of coordination across the FDA and with U.S. government organizations and marks the first domestic supply of Mo-99 – the source of Tc-99m – in 30 years, which will help to ensure more reliable, clean and secure access to this important imaging agent used in nuclear medicine.”