PT - JOURNAL ARTICLE AU - Gorovets, Alexander AU - Marzella, Louis AU - Rieves, Dwaine AU - Yang, Lucie TI - Efficacy Considerations for U.S. Food and Drug Administration Approval of Diagnostic Radiopharmaceuticals AID - 10.2967/jnumed.112.117804 DP - 2013 Aug 01 TA - Journal of Nuclear Medicine PG - 1479--1484 VI - 54 IP - 8 4099 - http://jnm.snmjournals.org/content/54/8/1479.short 4100 - http://jnm.snmjournals.org/content/54/8/1479.full SO - J Nucl Med2013 Aug 01; 54 AB - The safety and efficacy expectations for U.S. Food and Drug Administration (FDA) approval of diagnostic radiopharmaceuticals (DRs) are described in laws that broadly apply to all prescription drugs and biologic products. These laws also outline efficacy expectations that are unique for DRs. The FDA regulations and guidance documents elaborate on DR efficacy expectations for clinical uses of the drugs, such as the delineation of anatomy, the characterization of a physiologic process, or the diagnosis of disease. As described in the FDA regulations, the approval of a DR necessitates that the imaging drug has the ability to provide clinically useful information. Here we cite approved DRs to illustrate how the imaging performance of the drugs was characterized in clinical studies and the clinical usefulness of the imaging information described in drug labels.