RT Journal Article SR Electronic T1 Efficacy Considerations for U.S. Food and Drug Administration Approval of Diagnostic Radiopharmaceuticals JF Journal of Nuclear Medicine JO J Nucl Med FD Society of Nuclear Medicine SP 1479 OP 1484 DO 10.2967/jnumed.112.117804 VO 54 IS 8 A1 Gorovets, Alexander A1 Marzella, Louis A1 Rieves, Dwaine A1 Yang, Lucie YR 2013 UL http://jnm.snmjournals.org/content/54/8/1479.abstract 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.