{"id":754,"date":"2018-05-07T07:25:23","date_gmt":"2018-05-07T07:25:23","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/fda-expanded-access-program-university-michigan\/"},"modified":"2026-03-06T13:04:58","modified_gmt":"2026-03-06T18:04:58","slug":"fda-expanded-access-program-university-michigan","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/fda-expanded-access-program-university-michigan\/","title":{"rendered":"FDA Expanded Access Program at the University of Michigan"},"template":"","categories":[24],"tags":[],"content-type":[41],"topic":[44,66,75],"update-type":[],"class_list":["post-754","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","content-type-guidance","topic-fda-drugs-devices-biologics","topic-investigator-study-team-responsibilities","topic-regulations-policies-federal-state-local"],"acf":{"use_legacy_editor":true,"updated_date":"2025-11-21 10:30:00","update_notice":false,"author":"IRBMED","summary":"For assistance in obtaining approval to use an Expanded Access <a class=\"gtip\" href=\"\/medschool\/glossary\/investigational\">investigational<\/a> product, contact\u00a0<a href=\"https:\/\/michr.umich.edu\/?s=miap\">MICHR IND \/ IDE Investigator Assistance Program (MIAP)<\/a>\u00a0by emailing\u00a0<a href=\"mailto:UM-Expanded-Access-Request@med.umich.edu\">UM-Expanded-Access-Request@med.umich.edu<\/a>\r\n\r\nThe <a class=\"gtip\" href=\"\/medschool\/glossary\/food-and-drug-administration-fda\">FDA<\/a> Expanded Access program allows a qualified physician to access <a class=\"gtip\" href=\"\/medschool\/glossary\/investigational-drug\">investigational drugs<\/a>, <a class=\"gtip\" href=\"\/medschool\/glossary\/biologics\">biologics<\/a>, and devices outside of a traditional clinical trial access mechanism for emergent\/ compassionate treatment of patients under limited circumstances when meeting certain criteria. FDA regulations allow access to investigational drugs\/devices for treatment purposes on a case-by-case basis.\r\n\r\nFor expanded access uses, FDA requires a special submission for drugs, biologics, or devices. <a class=\"gtip\" href=\"\/medschool\/glossary\/institutional-review-board-irb\">IRB<\/a> initial and continuing approval at convened Board, and <a class=\"gtip\" href=\"\/medschool\/glossary\/informed-consent\">informed consent<\/a> per usual IRB requirements, are required. For <a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/emergency-use-test-article-life-threatening-circumstances\">Emergency Use<\/a> cases, some of these requirements may be met after the fact: see \u201cIRB oversight\u201d heading at IRBMED\u00a0Emergency Use\u00a0guidance webpage.\r\n\r\n<a href=\"https:\/\/michr.umich.edu\/?s=miap\">MICHR IND \/ IDE Investigator Assistance Program (MIAP)<\/a>\u00a0assists U-M physicians seeking to use FDA Expanded Access Program in\r\n<ul>\r\n \t<li>understanding the regulatory process involved, and assists in<\/li>\r\n \t<li>fulfilling reporting obligations to the FDA<\/li>\r\n \t<li>fulfilling reporting obligations to the IRB, including the\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/informational\/eresearch-regulatory-management-errm\">eResearch application<\/a><\/li>\r\n<\/ul>\r\nThere is no charge to physicians for MIAP services related to Expanded Access.","button_links":null,"related_content":[733],"legacy_path":"fda-expanded-access-program-university-michigan","legacy_node_id":295,"legacy_related_nids":"399","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"ADDITIONAL RESOURCES","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"U-M <a class=\"gtip\" href=\"\/medschool\/glossary\/hrpp\">HRPP<\/a>\u00a0<a href=\"https:\/\/hrpp.umich.edu\/resource\/operations-manual\/\">Operations Manual<\/a>\u00a0\u00a0Part 8.III\r\n\r\n<a href=\"https:\/\/hrpp.umich.edu\/resource\/irb-standard-operating-procedures\/\">U-M IRB Standard Operating Procedures<\/a>\u00a0Part 8.III\r\n\r\nIRBMED website guidance\r\n<ul>\r\n \t<li><a href=\"https:\/\/az.research.umich.edu\/medschool\/document\/emergency-use-test-article-life-threatening-circumstances\/\">Emergency Use of a Test Article in Life-Threatening Circumstances<\/a><\/li>\r\n \t<li><a href=\"https:\/\/az.research.umich.edu\/medschool\/document\/humanitarian-use-device-requirements-u-m-physicians-investigators\/\">Humanitarian Use Device Requirements for UM Physicians and Investigators<\/a><\/li>\r\n<\/ul>\r\n<a class=\"gtip\" href=\"\/medschool\/glossary\/food-and-drug-administration-fda\">FDA<\/a> Guidance, Information, and regulations on Expanded Access\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/NewsEvents\/PublicHealthFocus\/ExpandedAccessCompassionateUse\/default.htm\">Expanded Access (Compassionate Use)<\/a>\u00a0overview webpage<\/li>\r\n \t<li>Devices guidance\/information\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/medicaldevices\/deviceregulationandguidance\/howtomarketyourdevice\/investigationaldeviceexemptionide\/ucm051345.htm\">Expanded Access for Medical Devices<\/a>\u00a0overview webpage<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Drugs\/<a class=\"gtip\" href=\"\/medschool\/glossary\/biologics\">Biologics<\/a> guidance\/information\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/news-events\/expanded-access\/expanded-access-categories-drugs-including-biologics\">Expanded Access Categories for Drugs (Including Biologics)<\/a> overview webpage<\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/aboutfda\/centersoffices\/officeofmedicalproductsandtobacco\/cder\/ucm163982.htm\">Physician Request for a Single Patient IND for Compassionate or Emergency Use<\/a><\/li>\r\n \t<li>Regulations\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-D\/part-312#subpart-I\">21 CFR 312 Subpart I<\/a> \u2013 Expanded Access to Investigational Drugs for Treatment Use<\/li>\r\n \t<li><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-812#812.36\">21 CFR 812.36<\/a> \u201cTreatment use of an investigational device\u201d<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null}],"update_notice_type":[97],"update_notice_start":"2025-11-21 00:00:00","update_notice_end":"2025-12-20 00:00:00","update_notice_text_blocks":[{"update_notice_text":"<div class=\"update-notice\">\r\n<div class=\"update-notice-inner\">\r\n<div class=\"update-notice--text\">\r\n<div class=\"update-notice--text--block\">\r\n\r\nMinor updates to references to the HRPP OM and U-M IRB SOPs, and URL updates.\r\n\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>"}],"global_contact_block":false,"contact_name":"","contact_email":"","contact_additional_info":"Contact us at\u00a0<a href=\"mailto:irbmed@umich.edu\">irbmed@umich.edu<\/a>\u00a0or 734-763-4768 \/ (Fax 734-763-1234)\r\n\r\n2800 Plymouth Road, Ann Arbor, MI 48109-2800\r\n\r\nA <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-contacts-roster#irbmed-staff\">list of IRBMED staff<\/a> is available at our website.\r\n\r\nEdited By: <a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: March 6, 2026 1:00PM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/754","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document"}],"about":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/types\/document"}],"version-history":[{"count":2,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/754\/revisions"}],"predecessor-version":[{"id":1904,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/754\/revisions\/1904"}],"acf:term":[{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type\/97"}],"acf:post":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/733"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=754"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=754"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=754"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=754"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=754"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=754"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}