TY - JOUR T1 - <sup>68</sup>Ga-PSMA-11 NDA Approval: A Novel and Successful Academic Partnership JF - Journal of Nuclear Medicine JO - J Nucl Med SP - 149 LP - 155 DO - 10.2967/jnumed.120.260455 VL - 62 IS - 2 AU - Giuseppe Carlucci AU - Robin Ippisch AU - Roger Slavik AU - Ashley Mishoe AU - Joseph Blecha AU - Shaojun Zhu Y1 - 2021/02/01 UR - http://jnm.snmjournals.org/content/62/2/149.abstract N2 - The University of California Los Angeles (UCLA) and University of California San Francisco (UCSF) codeveloped 68Ga-PSMA-11 by conducting a bicentric pivotal phase 3 clinical trial for PET imaging for prostate cancer. On December 1, 2020, 2 separate new drug applications (NDAs) submitted by each institution (NDA 212642 for UCLA and NDA 212643 for UCSF) were approved by the Food and Drug Administration as the first drug for PET imaging of prostate-specific membrane antigen (PSMA)–positive lesions in men with prostate cancer. This article briefly describes the background, clinical development, regulatory approach, and regulatory process for NDA filing and approval. In the second part of this article, key chemistry, manufacturing, and controls (CMC) information is provided to facilitate abbreviated new drug application (ANDA) submission. ER -