2023年9月,FDA颁布了《Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products》的最新修订草案,介绍了申请人如何与FDA就PDUFA药品开发和审查召开正式会议的情况,讨论了良好会议管理实践原则,并描述了申请、准备、安排、举行和记录此类正式会议的标准化程序。新指南相比于2009年5月的《Formal Me...
FDA更新创新药正式沟通交流会议指南（Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry）前言日前，笔者注意到FDA于2023年09月22日发布了《FDA与处方药申办者或申请人之间的正式会议》现有指南草案的修订草案，该草案新增了Type D和INTERACT会议，更大范围的涵盖了药...
There are four types of formal meetings under PDUFA that occur between requesters and FDA Type A, Type B, Type B (end of phase (EOP)), and Type C. A. Type A Meeting Type A meetings are those that are necessary for ...
Type A和Type C*类会议会议申请时提交会议申请表和会议支持性资料;Type B类会议会议申请时仅提交会议申请表,会议召开/书面回复前30天递交会议支持性资料;Type B (EOP) 类会议会议申请时仅提交会议申请表,会议召开/书面回复前50天...
There are four types of formal meetings under PDUFA that occur between requesters and FDA Type A, Type B, Type B (end of phase (EOP)), and Type C. A. Type A Meeting Type A meetings are those that are necessary for an otherwise stalled product development program to proceed or to addr...
2.https://www.thebrackengroup.com/blog/new-fda-type-d-meeting 3. SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products. 相关文件下载、服务及学习课程: 合规文库:美国联邦食品,药品及化妆品法(FD&C法)(FDA) ...
FDA describes four types of meetings. Type A meetings are those that are necessary for an otherwise stalled product development program to proceed or to address an important safety issue. Before submitting a Type A meeting request, requesters should contact the review division or office to discuss...
计划与CDE进行沟通交流的申请者,应参考CDE 2020年12月11日发布的《药物研发与技术审评沟通交流管理办法》执行。而计划向FDA进行会议沟通的申请人,则参考2017年FDA发布的指南《Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products》。
计划与CDE进行沟通交流的申请者,应参考CDE 2020年12月11日发布的《药物研发与技术审评沟通交流管理办法》执行。而计划向FDA进行会议沟通的申请人,则参考2017年FDA发布的指南《Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products》。
There are 3 types of EOP meetings that can occur at critical junctures within a drug development program: End-of-phase 1 meeting, End-of-phase 2A meetings, and End-of-phase 2 meetings. EOP1 Meetings What: End-of-phase 1 (EOP1) meetings are formal PDUFA Type B meetings held between ...