From Our Perspective: FDA’s Role in Helping a Critical Medical Isotope Meet Sufficient Supply in the US for First Time
By: Joseph Rajendran, M.D. (Medical Doctor), FASNC (Fellow of the American Society of Nuclear Cardiology), FACNM (Fellow of the American College of Nuclear Medicine), Medical Officer, FDA (U.S. Food and Drug Administration), CDER (Center for Drug Research and Evaluation), OND (Office of New Drugs), OSM (Office of Specialty Medicine), DIRM (Division of Imaging and Radiation Medicine)
Recently FDA’s Center for Drug Evaluation and Research (CDER) and the U.S. Department of Energy’s National Nuclear Security Administration (DOE/NNSA) recognized that the U.S. has reached a sufficient supply of molybdenum-99 (Mo-99) produced without highly enriched uranium (HEU). Mo-99 is an important radioactive isotope used in medical imaging to detect cancer and other potentially fatal conditions.