Thomas Hope, MD

Thomas Hope, MD, Assistant Professor in Residence in Abdominal Imaging and Nuclear Medicine in the Department of Radiology at the University of California, San Francisco, explains how an academic institution successfully submits a new drug application (NDA) to the US Food and Drug Administration (FDA), using the NDA for prostate-specific membrane antigen (PSMA) 11 as an example. He notes the limitations that academia has in this area, and recommends that, going forward, institutions design imaging studies so that they report usable detection rates and have blinded readers.