Sue Bunning, Danae Christodoulou, Jonathan E. Cohen, Cathy S. Cutler, David W. Dick, Krishnakali Ghosh, Christopher Ignace, Ravindra K. Kasliwal, Hsiaoju Lee, Libero Marzella, Tim Pohlhaus, Peter J.H. Scott, Sally W. Schwarz, Irum A. Syed, Henry F. VanBrocklin, Laura R. Wasil, Steven S. Zigler
{"title":"Proceedings: PET Drugs—A 2023 Workshop on Product Quality, Regulatory Submissions, Facility Inspections, and Benefit–Risk Considerations","authors":"Sue Bunning, Danae Christodoulou, Jonathan E. Cohen, Cathy S. Cutler, David W. Dick, Krishnakali Ghosh, Christopher Ignace, Ravindra K. Kasliwal, Hsiaoju Lee, Libero Marzella, Tim Pohlhaus, Peter J.H. Scott, Sally W. Schwarz, Irum A. Syed, Henry F. VanBrocklin, Laura R. Wasil, Steven S. Zigler","doi":"10.2967/jnumed.125.270011","DOIUrl":null,"url":null,"abstract":"<p>Advances in PET radiopharmaceutical technologies necessitate continued dialogue between members of the PET drug manufacturing community and the U.S. Food and Drug Administration (FDA) to ensure that these drugs continue to be safe and effective and are sustainably supplied in accordance with regulatory commitments and current good manufacturing practice (cGMP) regulations. After the success of the 2020 PET drugs workshop, the FDA hosted a follow-up public workshop entitled “PET: Product Quality, Regulatory Submissions, Facility Inspections, and Benefit–Risk Considerations.” The 2023 workshop addressed knowledge gaps that emerged during the 2020 workshop and themes from responses to a survey of PET drug manufacturers. The goal of this workshop was to support continued communication between the FDA and PET stakeholders to drive clarity toward PET cGMP regulations described in the <em>Code of Federal Regulations</em> (title 21, part 212) and PET Drug cGMP guidance documents, with the objective to improve compliance with PET drug manufacturing guidelines. In addition, investigational PET drugs (<em>Code of Federal Regulations</em>, title 21, part 312) were discussed, as they are intimately connected with the approval process and eventual cGMP manufacturing regulations once they matriculate to clinical use. The workshop was held on November 13–14, 2023, on the FDA campus in Silver Spring, MD. The Society of Nuclear Medicine and Molecular Imaging, the Medical Imaging and Technology Alliance, and the Coalition of PET Drug Manufacturers cosponsored the workshop with the FDA. This article summarizes the discussions that were conveyed at this workshop.</p>","PeriodicalId":22820,"journal":{"name":"The Journal of Nuclear Medicine","volume":"93 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"The Journal of Nuclear Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2967/jnumed.125.270011","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Advances in PET radiopharmaceutical technologies necessitate continued dialogue between members of the PET drug manufacturing community and the U.S. Food and Drug Administration (FDA) to ensure that these drugs continue to be safe and effective and are sustainably supplied in accordance with regulatory commitments and current good manufacturing practice (cGMP) regulations. After the success of the 2020 PET drugs workshop, the FDA hosted a follow-up public workshop entitled “PET: Product Quality, Regulatory Submissions, Facility Inspections, and Benefit–Risk Considerations.” The 2023 workshop addressed knowledge gaps that emerged during the 2020 workshop and themes from responses to a survey of PET drug manufacturers. The goal of this workshop was to support continued communication between the FDA and PET stakeholders to drive clarity toward PET cGMP regulations described in the Code of Federal Regulations (title 21, part 212) and PET Drug cGMP guidance documents, with the objective to improve compliance with PET drug manufacturing guidelines. In addition, investigational PET drugs (Code of Federal Regulations, title 21, part 312) were discussed, as they are intimately connected with the approval process and eventual cGMP manufacturing regulations once they matriculate to clinical use. The workshop was held on November 13–14, 2023, on the FDA campus in Silver Spring, MD. The Society of Nuclear Medicine and Molecular Imaging, the Medical Imaging and Technology Alliance, and the Coalition of PET Drug Manufacturers cosponsored the workshop with the FDA. This article summarizes the discussions that were conveyed at this workshop.
PET放射性药物技术的进步需要PET药物制造界成员与美国食品和药物管理局(FDA)之间的持续对话,以确保这些药物继续安全有效,并按照监管承诺和现行良好生产规范(cGMP)规定持续供应。在2020年PET药品研讨会成功举办后,FDA举办了一场名为“PET:产品质量、监管申报、设施检查和利益风险考虑”的后续公开研讨会。2023年研讨会解决了2020年研讨会期间出现的知识差距,以及对PET药品制造商调查的回应主题。本次研讨会的目的是支持FDA和PET利益相关者之间的持续沟通,以推动联邦法规(title 21, part 212)和PET药物cGMP指导文件中描述的PET cGMP法规的清晰度,目的是提高PET药物生产指南的合规性。此外,还讨论了研究性PET药物(Code of Federal Regulations, title 21, part 312),因为一旦进入临床使用,它们与批准过程和最终的cGMP生产法规密切相关。该研讨会于2023年11月13日至14日在马里兰州银泉市的FDA园区举行。核医学和分子成像学会、医学成像和技术联盟以及PET药物制造商联盟与FDA共同主办了该研讨会。本文总结了本次研讨会的讨论内容。