[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-171498-105":53,"doc-detail-171498-en":127},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","type-c-meeting-request-and-meeting-package-templates","TYPE C MEETING REQUEST AND MEETING PACKAGE TEMPLATES","","模板面向PaVe-GT平台下的AAV基因治疗项目，提供与美国FDA进行Type C会议所需的请求信与会议包撰写范式，用于提高监管文件准备效率。内容强调需先提交meeting request并附带独立cover letter，再按要求提交meeting package，且蓝色斜体占位信息应替换为特定试验产品与适应症。文中还列出模板包含的草拟问题与最终问题清单，并提醒移除说明性文本框后再提交，同时对相关SOP与FDA网站要求进行查阅。",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":41,"@type":70,"position":76},"https://docshare.wps.com/template/letters/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/type-c-meeting-request-and-meeting-package-templates/171498/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/type-c-meeting-request-and-meeting-package-templates/171498.png","ImageObject",442,249,{"name":88,"@type":89},"Chloe Bennett","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-20","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",10,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"Type C会议请求和会议包提交的先后顺序是什么？","Question",{"text":109,"@type":110},"需先提交Type C meeting request，随后提交meeting package。两者存在部分重叠章节，但每次提交都必须包含独立的cover letter。","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"模板中的蓝色斜体占位文本应如何处理？",{"text":114,"@type":110},"蓝色斜体文本与方括号内的内容用于指导信息，应替换为与研究产品和适应症相关的具体信息后再使用。",{"name":116,"@type":107,"acceptedAnswer":117},"使用该模板前需要参考哪些监管要求来源？",{"text":118,"@type":110},"文中建议使用FDA最新的SOPP-8101.1获取最新要求与时间表，并查阅FDA网站上关于细胞与基因治疗相关的预IND会议（pre-IND meetings）指南与提交信息。","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},171498,1788283669,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":40,"category_name":41,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":40,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":126,"read_time":140},962084925782,"https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc","TYPE C MEETING REQUEST AND MEETING PACKAGE TEMPLATES\nDisclaimer: National Center for Advancing Translational Sciences (NCATS) and National Institutes of Health (NIH) provide no warranties, representations, or guarantees that resources available on the Platform Vector-Gene Therapy (PaVe-GT) website will successfully apply to any specific project, disease, or condition. Furthermore, NIH disclaims any liability and provides no indemnification. A full list of terms and conditions for the use of PaVe-GT resources is available at \u0013 HYPERLINK \"https://pave-gt.ncats.nih.gov/terms-conditions-and-disclaimers/\" \u0014pave-gt.ncats.nih.gov/ terms-conditions-and-disclaimers/\u0015.\nThe following template has been generated based on the NCATS Platform Vector Gene Therapy (PaVe-GT) team’s experience in preparing a Type C meeting request for the U.S. Food and Drug Administration (FDA). PaVe-GT is a pilot project that tests whether the efficiency of gene therapy trial startup can be improved through the standardization of processes across adeno-associated virus (AAV) gene therapies for four rare diseases. An important goal of PaVe-GT is to share project results and lessons learned with the public in such a way that the information may be used by any interested party in improving efficiency in the development of an AAV gene therapy. Specifically, as our projects progress through the different phases of drug development, we intend to make more information publicly available. This includes FDA meeting requests and packages, toxicology and biodistribution data, Investigational new drug (IND) filings and corresponding communications with the FDA, and other study documents. Please visit and subscribe to the PaVe-GT website for project updates and resources at \u0013 HYPERLINK \"http://pave-gt.ncats.nih.gov\" \\h \u0014pave-gt.ncats.nih.gov\u0015.\nInvestigators may use this tool to develop their own Type C meeting request and meeting package. The use of this meeting template can increase efficiency in preparing regulatory documents. An accompanying \u0013 HYPERLINK \"https://journals.sagepub.com/doi/full/10.1177/10430342261452217\" \u0014article\u0015, titled Adeno-Associated Virus Gene Therapy Translation: Lessons from Early Regulatory Meetings, describing the Type C meeting process, was published in Human Gene Therapy in 2026. We encourage reading the article before using this template, and for current regulatory guidelines and requirements, including submission information, please consult the \u0013 HYPERLINK \"https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/otp-pre-ind-meetings\" \u0014FDA website\u0015 and \u0013 HYPERLINK \"https://www.fda.gov/media/84040/download\" \u0014SOPP 8101.1\u0015.\nInstructions for using this template:\nThis document includes two templates:\nTemplate for drafting a Type C meeting request (cover letter, request details, and list of draft questions)\nTemplate for drafting a Type C meeting package (cover letter, list of final questions, meeting package contents with background information and supporting data)\nThe template includes italicized blue text within brackets (intended to serve as guidance) and standard text in regular font. The italicized blue text along with the brackets should be substituted with information pertinent to the investigational product. The text in regular font may be utilized without modification.\nThe template also includes rectangular text boxes providing section overviews and/or instructions, and these text boxes and content should be removed before submitting the Type C meeting request or meeting package.\nTable of Contents\n\u0013 HYPERLINK \\l \"meetingrequest\" \u0014A. Template for drafting a Type C meeting request………….…...3\u0015\n\u0013 HYPERLINK \\l \"meetingpackage\" \u0014B. Template for drafting a Type C meeting package…………….10\u0015\n\u000f\nA. Template for drafting a Type C meeting request\nInstructions: Scheduling a Type C meeting with the FDA requires the sponsor to submit a meeting request followed by a meeting package. These submissions have some overlapping sections, but each ","cbCaijsUJA9UbB25","https://ap.wps.com/l/cbCaijsUJA9UbB25","docx",116466,"English","# A. Template for drafting a Type C meeting request\n## Instructions and cover letter structure\n# B. Template for drafting a Type C meeting package\n## Instructions and meeting package structure","[{\"question\":\"Type C会议请求和会议包提交的先后顺序是什么？\",\"answer\":\"需先提交Type C meeting request，随后提交meeting package。两者存在部分重叠章节，但每次提交都必须包含独立的cover letter。\"},{\"question\":\"模板中的蓝色斜体占位文本应如何处理？\",\"answer\":\"蓝色斜体文本与方括号内的内容用于指导信息，应替换为与研究产品和适应症相关的具体信息后再使用。\"},{\"question\":\"使用该模板前需要参考哪些监管要求来源？\",\"answer\":\"文中建议使用FDA最新的SOPP-8101.1获取最新要求与时间表，并查阅FDA网站上关于细胞与基因治疗相关的预IND会议（pre-IND meetings）指南与提交信息。\"}]","TYPE C MEETING REQUEST AND MEETING PACKAGE TEMPLATES | DOCX",6]