{"id":9022,"date":"2017-02-18T13:37:03","date_gmt":"2017-02-18T21:37:03","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=9022"},"modified":"2025-11-19T13:50:02","modified_gmt":"2025-11-19T21:50:02","slug":"specu","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/guidance\/expanded-access\/specu\/","title":{"rendered":"Single Patient Emergency or Compassionate Use"},"content":{"rendered":"<h3>These documents provide instructions for UW physicians who wish to use an investigational drug, device or biologic for clinical treatment of a single patient. FHCC physicians may use this process for emergency, but not compassionate uses.<\/h3>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/app-emergency-drug\/\">APPLICATION Notification of Emergency Use, Drug or Biologic<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/app-emergency-device\/\">APPLICATION Notification of Emergency Use, Device<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/app-compassionate-device\/\">APPLICATION Notification of Compassionate Use, Device<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/app-non-emergency-drug\/\">APPLICATION Notification Single Patient Non-Emergency Expanded Access Use, Drug or Biologic<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/template-consent-form-emergency-or-compassionate-use\/\">TEMPLATE Consent Form, Emergency or Compassionate Use<\/a><\/li>\n<\/ul>\n<h3>Specific Requirements<\/h3>\n<ul>\n<li>All requirements are described in the APPLICATION documents.<\/li>\n<li>It is not necessary to obtain the concurrence of an IRB chair or to inform the Human Subjects Division (HSD) <strong>before<\/strong> the emergency or compassionate use.<\/li>\n<li>Chair Concurrence or full IRB approval is required before Single Patient Non-Emergency Expanded Access Use.<\/li>\n<li>The special consent template listed above must be used to ensure compliance with FDA regulations.<\/li>\n<\/ul>\n<h3>What is the difference between <strong>emergency<\/strong> use and <strong>compassionate<\/strong> use?<\/h3>\n<p>The Single Patient Emergency and Compassionate Use mechanisms allow for use of investigational drugs, biologics, or devices to treat or diagnose patients when specific criteria are met. Both types of use are generally intended for the clinical treatment of a single patient. See <strong><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/expanded-access\/\">GUIDANCE Expanded Access<\/a><\/strong> for detailed information.<\/p>\n<p>Drugs: <strong>Emergency<\/strong> use means that there is not sufficient time to obtain standard IRB review and approval before the drug must be used. UW and FHCC define this as less than seven business days. The drug division of the FDA does not recognize the concept of <strong>compassionate<\/strong> use. If the use is not an emergency, then the treating physician is required to obtain standard IRB review and approval (like a research study) before using the drug. Physicans can request, via section 10.b on Form FDA 3926, authorization to obtain concurrence by an IRB chairperson in lieu of full IRB review. If this has been requested, the treating physician can use <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/app-non-emergency-drug\/\">APPLICATION Single Patient Non-Emergency Expanded Access Use, Drug or Biologic<\/a> to facilitate the review. Prior FDA permission and Investigational Drug Exemption (IND) are required in emergency and non-emergency situations.<\/p>\n<p>Devices: <strong>Emergency<\/strong> use means that there is not sufficient time to use existing procedures to obtain FDA approval (Investigational Device Exemption, or IDE) before the device must be used. <strong>Compassionate<\/strong> use means that the use does not meet the criteria for emergency use, and therefore prior FDA approval (IDE) is required before the device can be used. Prospective standard IRB review and approval (like a research study) is not required for emergency or compassionate use.<\/p>\n<h3>Are these also the procedures for using a <strong>Humanitarian Use Device<\/strong> (HUD)?<\/h3>\n<p>A HUD is a device that has been approved by the FDA for treatment or diagnosis of a disease or condition that affects fewer than 8,000 individuals per year in the United States. See this <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/approved-huds\/\">list of HUDs<\/a> that have been approved by the UW IRB for &#8220;on-label&#8221; clinical use at UW Medicine. The procedures for using a HUD depend upon the purpose and circumstances. See <strong><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/\">GUIDANCE Humanitarian Use Device<\/a><\/strong> for details and submission instructions.<\/p>\n<h2 id=\"9\">Version Information<\/h2>\n<p>Open the accordion below for version changes to this guidance.<\/p>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Version History<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<table>\n<tbody>\n<tr>\n<th style=\"background-color: #4b2e83; color: #ffffff; text-align: center;\">Version Number<\/th>\n<th style=\"background-color: #4b2e83; color: #ffffff; text-align: center;\">Posted Date<\/th>\n<th style=\"background-color: #4b2e83; color: #ffffff; text-align: center;\">Implementation Date<\/th>\n<th style=\"background-color: #4b2e83; color: #ffffff; text-align: center;\">Change Notes<\/th>\n<\/tr>\n<tr>\n<td>1.2<\/td>\n<td>03.27.2025<\/td>\n<td>03.27.2025<\/td>\n<td>Update to add procedure for Single Patient Non-Emergency Expanded Access Use, Drug or Biologic<\/td>\n<\/tr>\n<tr>\n<td>1.1<\/td>\n<td>08.25.2022<\/td>\n<td>08.25.2022<\/td>\n<td>Revise title; revise URL to nest under GUIDANCE Expanded Access; update links to new web guidance on HUDs and Expanded Access<\/td>\n<\/tr>\n<tr>\n<td>1.0<\/td>\n<td>02.18.2017<\/td>\n<td>02.18.2017<\/td>\n<td>Newly posted guidance<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<\/div>\n<p><strong>Keywords<\/strong>: Expanded access; FDA<\/p>\n","protected":false},"excerpt":{"rendered":"<p>These documents provide instructions for UW physicians who wish to use an investigational drug, device or biologic for clinical treatment of a single patient. FHCC physicians&#8230;<\/p>\n","protected":false},"author":158,"featured_media":0,"parent":43373,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder-units-small-hero.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-9022","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Single Patient Emergency or Compassionate Use - UW Research<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/expanded-access\/specu\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Single Patient Emergency or Compassionate Use - UW Research\" \/>\n<meta property=\"og:description\" content=\"These documents provide instructions for UW physicians who wish to use an investigational drug, device or biologic for clinical treatment of a single patient. 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