该指南草案正式通过后将取代2023年6月2号发布的“Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”和1998年2月19日发布的““Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent
该指南草案正式通过后将取代2023年6月2号发布的“Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”和1998年2月19日发布的““Guidance onPMAInteractive Procedures for Day-100 Meetings and Subsequent
而FDA的Q-Sub则包含submission issue request,informational meeting,pre-submission等多种申办方希望和FDA分享或讨论问题的请求种类。其中我们涉及较多的Pre-submission(专门针对IDE模式下的研究在开展临床试验前与FDA的沟通咨询服务)可咨询的问题包括:FDA关于非临床...
^https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-information-premarket-notification-510k-submissions-devices-labeled ^https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-su...
Also known as the Pre-Submission Program, or Q-Sub for short, the program allows manufacturers of medical devices and in vitro diagnostic devices to obtain feedback on the regulatory process and requirements for devices they have in development. The Q-Sub program’s origin is in the Pre-IDE...
●赞助商可以通过CDRH的Q-submission程序提交研究风险确定预提交。 ●发起人也可以通过可选的简化的提交过程来寻求风险确定,以用于新的 INDs 的肿瘤试验研究设备。 参考资料: 1.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-circulating-tumor-deoxyribonucleic-acid-early-stage-solid...
●赞助商可以通过CDRH的Q-submission程序提交研究风险确定预提交。 ●发起人也可以通过可选的简化的提交过程来寻求风险确定,以用于新的 INDs 的肿瘤试验研究设备。 《ctDNA指南草案》下载: 点击左下角“阅读原文”,提取码:145d 参考资...
DRAFTGUIDANCE草案指南 Thisdraftguidancedocumentisbeingdistributedforcommentpurposes only.本草案指南文件仅用于征求意见。 DocumentissuedonMarch1s,2024. 文件发布于2024年3月1日。 Youshouldsubmitcommentsandsuggestionsregardingthisdraftdocumentwithin60daysof
2. Pre-submission的积极作用 Pre-submission途径,便于FDA提前审核临床和非临床研究的方案,以及其他关键信息,申请人在获得 FDA 反馈后,可在研究方案中尽可能地吸纳FDA意见。 Pre-submission提交,既有利于提高之后正式递交的文件质量,还能提升提交的品质并缩短总体审查。
"Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and for the Completion of the Form FDA 356h, 'Application to Market a New Drug, ...