RT Journal Article SR Electronic T1 68Ga-PSMA-11 NDA Approval: A Novel and Successful Academic Partnership JF Journal of Nuclear Medicine JO J Nucl Med FD Society of Nuclear Medicine SP 149 OP 155 DO 10.2967/jnumed.120.260455 VO 62 IS 2 A1 Carlucci, Giuseppe A1 Ippisch, Robin A1 Slavik, Roger A1 Mishoe, Ashley A1 Blecha, Joseph A1 Zhu, Shaojun YR 2021 UL http://jnm.snmjournals.org/content/62/2/149.abstract AB 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.