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# FDA Role in Medical Isotope Development
- URL: https://www.fdaweb.com/fda-role-in-medical-isotope-development/
- Published: 2022-05-12T12:00:00.000Z
- Updated: 2026-09-14T17:44:20.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5151798

The U.S. now has a sufficient supply of molybdenum-99 (Mo-99) produced without highly enriched uranium, thanks to efforts by FDA and other government and private organizations. In a CDER *From Our Perspective* online [post](https://www.fda.gov/drugs/news-events-human-drugs/our-perspective-fdas-role-helping-critical-medical-isotope-meet-sufficient-supply-us-first-time?utm%5Fmedium=email&utm%5Fsource=govdelivery), Division of Imaging and Radiation Medicine medical officer **Joseph Rajendran** says the Center has been working to shift the production of medical isotopes from highly enriched uranium (which can be diverted and used to create weapons) to low enriched uranium and non-uranium sources.

“CDER’s role is to advance innovative technologies for increasing domestic production by providing expert advice during the development phase of the product and assessing the quality of the product prior to approval and during the post-marketing phase,” Rajendran says. “FDA nuclear chemists, microbiologists, engineers, and a broad range of scientists and medical professionals from both CDER and CDRH provided important scientific and technical expertise throughout the development of this innovative technology.”