The University of Iowa recently completed a 4-y expedition into the uncharted waters of the Food and Drug Administration (FDA) new-drug application (NDA) process that ultimately resulted in approval of ⁶⁸Ga-DOTATOC in August 2019. The journey was enlightening, revealing a highly structured, arcane, but rigorous regulatory approval process. The FDA proved to be an efficient, reasonable, and communicative regulatory body that achieved balance between support of the initiative and its mission-bound, process-bound duty to ensure that the application met the expected safety and efficacy standards of the agency. With several 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, this article briefly describes the start-to-finish story for ⁶⁸Ga-DOTATOC, including a description of the clinical trials, a broad overview of the structured content of the NDA document, and the distilled experiences associated with the ⁶⁸Ga-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 in future academically sponsored NDA filings for PET imaging agents.

爱荷华大学最近完成了对美国食品药品管理局（FDA）新药申请（NDA）流程未知水域的4年考察，最终获得了⁶⁸Ga-DOTATOC于2019年8月发布。这一旅程令人鼓舞，揭示了一个高度结构化，神秘却严格的法规批准流程。事实证明，FDA是一个有效，合理和沟通良好的监管机构，它在该计划的支持与其任务规定，过程规定的职责之间取得了平衡，以确保应用程序符合该机构的预期安全性和有效性标准。由于有几种临床上有价值的无知识产权的PET放射性药物处于监管领域，而没有行业领导者将其获得市场认可，则可能有理由要求分子成像界做出更大的共同努力，以产生更好的理解，支持甚至基础设施。学术NDA。第一步⁶⁸ Ga-DOTATOC，包括对临床试验的描述，对NDA文件结构内容的广泛概述，以及与⁶⁸ Ga-DOTATOC NDA工艺相关的摘要。可以预期，随着与FDA药物注册过程有关的信息的持续自由共享，在将来由PETA成像专家提供的学术资助的NDA申请中，它将证明不那么令人生畏，并且效率更高。