Abstract
The University of Iowa recently completed a four-year expedition into the uncharted waters of the FDA New Drug Application (NDA) process that ultimately resulted in approval of [Ga-68]DOTATOC in August of 2019. The journey was enlightening, revealing a highly structured, arcane, but rigorous regulatory approval process. FDA proved to be an efficient, reasonable, and communicative regulatory body that achieved balance between support of the initiative, and their mission-bound/process-bound duty to assure the application met the expected safety and efficacy standards of the agency. With a number of clinically valuable PET radiopharmaceuticals without intellectual property residing in regulatory limbo without industry champions to bring them to marketing approval, there may be justification for a more concerted effort from the molecular imaging community into generating better understanding, support, and perhaps even infrastructure for the academic NDA. As a first step, the accompanying manuscript briefly describes the start-to-finish story for [Ga-68]DOTATOC, including a description of the clinical trials, a broad overview of the NDA structured document content, and the distilled experiences associated with the [Ga-68]DOTATOC NDA process. It is anticipated that with sustained free sharing of information relating to the FDA drug registration process, it will prove less daunting and more efficient for future academically sponsored NDA filings for PET imaging agents.
- Copyright © 2020 by the Society of Nuclear Medicine and Molecular Imaging, Inc.