Regulatory Considerations for Radiotherapeutics and Radiodiagnostics

Scientific innovation and advances in ligand targeting have spurred the development of many different types of radiopharmaceutical (RPs) – radioisotopes bound to biological molecules to target specific organs, tissues, or cells within the body — with a wide range of clinical uses. As those uses have proliferated, and as research has continued to yield novel agents, developers and marketers of RP products are confronted with a regulatory environment that can be challenging to navigate, with health authorities struggling to keep up with the pace of innovation.