View guidelines on radiopharmaceutical therapies from SNMMI and other organizations, including procedure standards for therapy, and applicable AUC.
Procedure standards help identify those elements of the procedure that are most important in obtaining a high-quality examination, while simultaneously controlling costs. Use of procedure standards will increase the applicability of clinical research among multiple institutions, in turn, increasing the value of research studies, particularly in the field of technology assessment. In the interest of creating strong, comprehensive documents, some standards were formally adopted by SNMMI in collaboration with other professional organizations.
Applicable to all countries: Clinicians involved in unsealed source therapy must be knowledgeable about and compliant with all applicable national and local legislation and regulations.
Applicable in the United States: The radiopharmaceutical(s) used for the diagnostic and therapeutic procedure(s) addressed in this guideline/guidance document is/are not approved by the Food and Drug Administration (FDA)in the United States. Therefore in the United States, these procedures should be performed only by physicians holding an FDA-approved Investigational New Drug (IND) application for the radiopharmaceutical.
**Regulatory Issues for EANM Guidelines
Appropriate Use Criteria (AUC) are statements containing indications describing when, and how often an intervention should be performed under the auspices of scientific evidence, clinical judgment, and patient values while avoiding unnecessary provisions of services.