68Ga-PSMA-11 NDA Approval: A Novel and Successful Academic Partnership

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.

Source: Journal of Nuclear Medicine - January 19, 2021 Category: Nuclear Medicine Authors: Carlucci, G., Ippisch, R., Slavik, R., Mishoe, A., Blecha, J., Zhu, S. Tags: The State of the Art Source Type: research