[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-171497-105":53,"doc-detail-171497-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","interact-meeting-request-and-package-pave-gt","INTERACT MEETING REQUEST and PACKAGE - PaVe-GT","","INTERACT MEETING REQUEST and PACKAGE template for the PaVe-GT (Platform Vector-Gene Therapy) program supports sponsors in preparing regulatory submissions to the U.S. Food and Drug Administration (FDA). The template includes a formal cover letter structure, confidentiality notice, placeholders for sponsor, product, date, and submission center, and sections to describe disease context, investigational product and mechanism of action. It also provides instructions for replacing bracketed guidance text, removing instruction boxes, and authorizing contacts for FDA communications, aiming to improve efficiency in assembling regulatory documentation.",{"@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/interact-meeting-request-and-package-pave-gt/171497/",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/interact-meeting-request-and-package-pave-gt/171497.png","ImageObject",442,249,{"name":88,"@type":89},"Sophia Brooks","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-19","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",8,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What is the purpose of this INTERACT meeting request and package template?","Question",{"text":109,"@type":110},"The template helps sponsors draft an FDA INTERACT meeting request and package for an investigational AAV gene therapy, improving efficiency in preparing regulatory documentation.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"What should be replaced before submitting the template?",{"text":114,"@type":110},"Replace the italicized blue guidance text inside brackets with information specific to the investigational product. Also remove the rectangular instruction/section-overview boxes included in the template.",{"name":116,"@type":107,"acceptedAnswer":117},"Who can receive FDA communications for the submission?",{"text":118,"@type":110},"The sponsor authorizes specific individuals to receive FDA communications by listing each authorized contact’s name, phone, and email in the designated section.","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},171497,1788283666,{"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":136,"language":137,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":61,"update_tm":126,"read_time":47},962084925636,"https://ap-avatar.wpscdn.com/davatar_994ba38a5ba835b3df7d355c54d3ed8d","INTERACT MEETING REQUEST AND PACKAGE TEMPLATE\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/\" \\h \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 an INitial Targeted Engagement for Regulatory Advice on CBER/CDER producTs (INTERACT) meeting request and package to 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 party interested 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 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 INTERACT meeting request and package. The utilization of this meeting template is expected to increase efficiency in preparing regulatory documentation. An accompanying white paper, \u0013 HYPERLINK \"https://www.liebertpub.com/doi/10.1089/hum.2024.230\" \u0014AAV Gene Therapy Development: Early Planning and Regulatory Considerations to Advance the PaVe-GT Program\u0015, that describes the method of drafting an INTERACT meeting request and package, was recently published in Human Gene Therapy. We encourage reading this white paper using this template and consulting the \u0013 HYPERLINK \"https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/otp-interact-meetings\" \u0014FDA website\u0015 for the most recent regulatory guidelines and requirements, including submission information.\nInstructions for using the template:\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 their contents should be removed before submitting the INTERACT meeting request and package.\n[Insert Sponsor Name]\n[Insert Name of Investigational Product]\nINTERACT MEETING REQUEST and PACKAGE\n[Insert Date of Submission to FDA]\n- CONFIDENTIAL -\nThis document and its contents are the property of and confidential to [Insert sponsor name]. Any unauthorized copying or use of this document is prohibited.\nRequest for an INTERACT meeting with [Insert name of FDA Center and Office] for [Insert name of Investigational Product and Indication]\nDear Dr. [Insert name of FDA Office Director]:\nWe are requesting an INTERACT meeting to discuss our gene therapy product, [Insert name of Investigational Product] for the potential treatment of [Proposed Indication].\n[Add 2-3 sentences regar","cbCaiuN8sjFouS7u","https://ap.wps.com/l/cbCaiuN8sjFouS7u","docx",112988,13,"English","# Instructions for using the template\n## Guidance text and placeholders\n## Document boxes to remove before submission\n# INTERACT MEETING REQUEST and PACKAGE\n## Confidentiality notice\n## Request details for the FDA Center and Office\n## Letter body: disease, product, mechanism, and included materials\n## Authorized contacts and sponsor contact information","[{\"question\":\"What is the purpose of this INTERACT meeting request and package template?\",\"answer\":\"The template helps sponsors draft an FDA INTERACT meeting request and package for an investigational AAV gene therapy, improving efficiency in preparing regulatory documentation.\"},{\"question\":\"What should be replaced before submitting the template?\",\"answer\":\"Replace the italicized blue guidance text inside brackets with information specific to the investigational product. Also remove the rectangular instruction/section-overview boxes included in the template.\"},{\"question\":\"Who can receive FDA communications for the submission?\",\"answer\":\"The sponsor authorizes specific individuals to receive FDA communications by listing each authorized contact’s name, phone, and email in the designated section.\"}]","INTERACT MEETING REQUEST and PACKAGE - PaVe-GT | DOCX"]