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
《Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program》简称Q-sub指南草案,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 ...
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...
某些改变可能从根本上改变产品的设计或性质,从而产生新产品。用新的研究产品开始临床研究一般需要提交单独的IND(requires the submission of a separate IND)(21 CFR 312.20)。我们建议您就可能改变产品并需要提交新IND的任何生产变更征求FDA的意见(本指南第七节)。可能需要提交新IND的变更示例包括: ...
●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...
Itdoes,haJever, offerguidancem acceptablea~caches tomeetingregulatoryrequiremnts. Different approaches naybe fol.lowed,buttheapplicautis encouraged to discuss significant variations in advance with m reviewers to preclude expmding time andeffortinpreparinga submissim that FDA may later determine to be ...
ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (September 2016) 3. 申请人可能需要明确人工智能在药品生产中的应用是否以及如何受到监管部门的监督 人工智能可用于各种生产操作,如监测和维护设备,确定需要持续改进的领域,调度和供应链物流,以及原材料的特性。
ensureproductquality—requiresasubmissiontoFDA(PAS,CBE-30,CBE-0,orannualreport)asdetailedinthe regulations(e.g.,21CFR314.70and314.97).Althoughtheseregulationsdonotexplicitlyspecifywhat constitutesanEC,theydosetfortharisk-basedparadigmforreportingchanges.Inaddition,existingFDA guidancedocumentsonpostapprovalchanges...