[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-203445-105":59,"doc-detail-203445-en":130},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":123,"head_meta":125,"extra_data":127,"updated_unix":129},105,"en","frm-ma-009a-expanded-access-request-form","FRM-MA-009a - Expanded Access Request Form","","Expanded Access Request Form for an investigational drug under U.S. FDA expanded access (21 CFR Part 312, Subpart I) and Health Canada Special Access Program (Food and Drug Regulations C.08.010–C.08.011). The form instructs requesting physicians or practitioners to complete all required fields in full, include supporting documentation, and submit to Summit to start the request process. It emphasizes that submission does not equal approval and outlines eligibility review, board decision workflow, and regulatory prerequisites before any investigational drug shipment.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/frm-ma-009a-expanded-access-request-form/203445/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/frm-ma-009a-expanded-access-request-form/203445.png","ImageObject",300,407,{"name":92,"@type":93},"8796093062539","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-06","2026-09-04",true,{"@type":102,"interactionType":103,"userInteractionCount":24},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"Who must complete and submit the Expanded Access Request Form?","Question",{"text":112,"@type":113},"The requesting physician or practitioner must complete the form in full and submit it to Summit to initiate the expanded access request process.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"Does submitting the form guarantee approval of expanded access?",{"text":117,"@type":113},"No. Submission does not constitute approval; all requests are subject to review and approval by Summit’s Expanded Access Review Board (EARB).",{"name":119,"@type":110,"acceptedAnswer":120},"Which regulatory pathways does the form support, and what determines which Part B is completed?",{"text":121,"@type":113},"The form supports the U.S. FDA expanded access pathway and the Health Canada Special Access Program. The selected regulatory pathway determines which Part B section is completed.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},203445,1788560842,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":66,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":133,"file_id":134,"file_url":135,"file_type":136,"file_size":137,"view_count":24,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":39,"language":138,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":139,"faqs":140,"seo_title":141,"seo_description":67,"update_tm":129,"read_time":46},8796093062539,"| Document ID and Title | FRM-MA-009a\u003Cbr>Expanded Access Request Form | |\n| --- | --- | --- |\n| Revision | 01 |  |\n\nInvestigational drug expanded access / special access—U. S. FDA (21 CFR Part 312, Subpart I) and Health Canada Special Access Program (Food and Drug Regulations C.08. 010–C.08. 011)  \n\n| REGULATORY PATHWAY—select one (determines which Part B to complete) |  |  |  |\n| --- | --- | --- | --- |\n|  |  | United States—FDA expanded access (21 CFR Part 312, Subpart I) →\u003Cbr>complete Part A and Part B-US |  |\n|  |  |  |  |\n|  |  |  |  |\n| |  |  | Canada—Health Canada Special Access Program (FDR\u003Cbr>C.08.010–C.08.011) → complete Part A and Part B-CA |\n\nINSTRUCTIONS: This form must be completed in full by the requesting physician/practitioner and submitted to Summit at [EAP@smmttx.com](EAP@smmttx.com) to initiate the expanded access request process. Incomplete submissions will not be processed. All fields are required unless otherwise indicated. Please type or print legibly. Supporting documentation must accompany this form at the time of submission.  \nIMPORTANT NOTICE: Submission of this form does not constitute approval of expanded access. All requests are subject to review and approval by Summit’s Expanded Access Review Board (EARB) in accordance with  \n[SOP-MA-009] . Summit retains sole and absolute discretion to approve or deny any request. No Investigational Drug will be shipped until all eligibility criteria are confirmed, all required agreements are fully executed, and all regulatory prerequisites are satisfied (including, for Canadian requests, Health Canada’s authorization) .  \nFOR INTERNAL USE ONLY  \n\n| Request Tracking No.: | |  |\n| --- | --- | --- |\n| Regulatory pathway: | | FDA (US)  Health Canada SAP (CA) |\n| Date Received: | |  |\n| Received By: | |  |\n| Completeness Med Affairs Review Date: | |  |\n| Completeness Confirmed (Y/N): |  Yes  No |  |\n| Date Forwarded to EARB Committee: | |  |\n| EARB Committee Decision: |  Approved  Denied  More info requested |  |\n| Decision Date: | |  |\n\nTMP-QA-023b-03 Confidential and Proprietary Page 1 of 8  \n\n| Document ID and Title | FRM-MA-009a\u003Cbr>Expanded Access Request Form | |\n| --- | --- | --- |\n| Revision | 01 |  |\n\nPART A—Expanded Access Request Details  \nComplete for ALL requests, regardless of pathway.  \nContact and Physician / Practitioner Information  \n\n| 1. Name of requesting physician / practitioner: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |\n| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |\n|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |\n| 2. Degree(s) and medical specialty / board certification(s): |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |\n| 3. Licensure information:\u003Cbr>Jurisdiction of licensure (state / province / country):\u003Cbr>\u003Cbr>License number(s):\u003Cbr>License expiration date(s):\u003Cbr>License status:\u003Cbr>\u003Cbr> Active  Inactive  Suspended  Other (explain): |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |\n| DEA registration number (U. S. requests only; not applicable to Health Canada\u003Cbr>SAP) :\u003Cbr>DEA registration expiration date (U. S. requests only) :\u003Cbr>|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |\n| 4. Clinical expertise and experience relevant to the requested disease or condition:\u003Cbr>Include approximate number of patients treated, years of experience, and any relevant subspecialty training or certifications. |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |\n| 5. Name of institution: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |\n| 6. Physician / institution address (","cbCaii4yNunbq13X","https://ap.wps.com/l/cbCaii4yNunbq13X","pdf",128445,"English","# Instructions and regulatory pathway\n## Submission requirements and approval statement\n# Internal tracking and decision process\n## Request tracking and completeness review\n## EARB committee decision\n# Part A: Expanded access request details\n## Requesting physician and institution information\n## Proposal information (drug, disease, rationale, monitoring)","[{\"question\":\"Who must complete and submit the Expanded Access Request Form?\",\"answer\":\"The requesting physician or practitioner must complete the form in full and submit it to Summit to initiate the expanded access request process.\"},{\"question\":\"Does submitting the form guarantee approval of expanded access?\",\"answer\":\"No. Submission does not constitute approval; all requests are subject to review and approval by Summit’s Expanded Access Review Board (EARB).\"},{\"question\":\"Which regulatory pathways does the form support, and what determines which Part B is completed?\",\"answer\":\"The form supports the U.S. FDA expanded access pathway and the Health Canada Special Access Program. The selected regulatory pathway determines which Part B section is completed.\"}]","FRM-MA-009a - Expanded Access Request Form | PDF"]