会议记录:PET药品- a - 2023产品质量研讨会,监管提交,设施检查和利益-风险考虑

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":"会议记录:PET药品- a - 2023产品质量研讨会,监管提交,设施检查和利益-风险考虑","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":"{\"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}","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

摘要

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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Proceedings: PET Drugs—A 2023 Workshop on Product Quality, Regulatory Submissions, Facility Inspections, and Benefit–Risk Considerations

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.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信