Project Facilitate

<!DOCTYPE html> <html lang="en" dir="ltr" prefix="og: https://ogp.me/ns#"> <head> <meta charset="utf-8" /> <script async src="https://www.googletagmanager.com/gtag/js?id=G-273DTKB5QW"></script> <meta name="description" content="The Oncology Center of Excellence Project Facilitate call center is a pilot program to assist oncology healthcare providers in requesting access to investigational therapies for patients with cancer." /> <meta name="dcterms.title" content="Project Facilitate" /> <meta name="dcterms.creator" content="Office of the Commissioner" /> <meta name="dcterms.description" content="The Oncology Center of Excellence Project Facilitate call center is a pilot program to assist oncology healthcare providers in requesting access to investigational therapies for patients with cancer." /> <meta name="dcterms.publisher" content="FDA" /> <meta name="dcterms.type" content="Article" /> <meta name="dcterms.source" content="FDA" /> <meta property="og:site_name" content="U.S. Food and Drug Administration" /> <meta property="og:type" content="Article" /> <meta property="og:url" content="https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate" /> <meta property="og:title" content="Project Facilitate" /> <meta property="og:description" content="Assisting Healthcare Providers with Expanded Access Requests for Investigational Oncology Products" /> <meta property="og:image" content="https://www.fda.gov/files/ProjectFacilitateBlackChemoPatient%26Doc11.17FL_2.jpg" /> <meta property="og:updated_time" content="Thu, 02/15/2024 - 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class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-2" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">Project Facilitate </h1> <p class="article-subtitle text-center">Assisting Healthcare Providers with Expanded Access Requests for Investigational Oncology Products</p> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fabout-fda%2Foncology-center-excellence%2Fproject-facilitate" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=Project%20Facilitate%20&url=https://www.fda.gov%2Fabout-fda%2Foncology-center-excellence%2Fproject-facilitate" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li class="lcds-share__item hidden-xs"> <a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.fda.gov%2Fabout-fda%2Foncology-center-excellence%2Fproject-facilitate&title=Project%20Facilitate%20&source=FDA" class="lcds-share__btn lcds-share--default__btn-linkedin js-share" id="linkedin-share" target="_blank"><span class="fa icon-linkedin" aria-hidden="true"></span>Linkedin</a> </li> <li class="lcds-share__item"> <a href="mailto:?subject=Project%20Facilitate%20&body=https://www.fda.gov%2Fabout-fda%2Foncology-center-excellence%2Fproject-facilitate" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <figure> <div> <div class="field field--name-image field--type-image field--label-inline"> <div class="field--label">Image</div> <div class="field--item"> <picture> <source srcset="/files/styles/main_image_small/public/ProjectFacilitateBlackChemoPatient%26Doc11.17FL_2.jpg?itok=rJVMLi7o 1x" media="all and (max-width: 320px)" type="image/jpeg" width="320" height="180"/> <source srcset="/files/styles/main_image_medium/public/ProjectFacilitateBlackChemoPatient%26Doc11.17FL_2.jpg?itok=tzmpc63w 1x" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" width="500" height="281"/> <source srcset="/files/styles/main_image_medium/public/ProjectFacilitateBlackChemoPatient%26Doc11.17FL_2.jpg?itok=tzmpc63w 1x" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" width="500" height="281"/> <source srcset="/files/styles/main_image_medium/public/ProjectFacilitateBlackChemoPatient%26Doc11.17FL_2.jpg?itok=tzmpc63w 1x" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" width="500" height="281"/> <source srcset="/files/styles/main_image_1/public/ProjectFacilitateBlackChemoPatient%26Doc11.17FL_2.jpg?itok=4OU6aYlu 1x" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" width="1020" height="574"/> <source srcset="/files/styles/main_image_1/public/ProjectFacilitateBlackChemoPatient%26Doc11.17FL_2.jpg?itok=4OU6aYlu 1x" media="all and (min-width: 1201px)" type="image/jpeg" width="1020" height="574"/> <img loading="eager" src="/files/styles/main_image_medium/public/ProjectFacilitateBlackChemoPatient%26Doc11.17FL_2.jpg?itok=tzmpc63w" width="500" height="281" alt="Project Facilitate Main Image 2021" class="img-responsive" /> </picture> </div> </div> </div> </figure> <p>Oncology Center of Excellence<em> </em><strong>Project Facilitate </strong>is a single point of contact call and information center created to help oncology healthcare providers or regulatory professionals submit an Expanded Access Request (also referred to as: Compassionate Use, Emergency IND, Single-Patient IND, or Pre-Approval) for an individual patient with cancer through FDA's Expanded Access Program.</p> <p>FDA’s Expanded Access Program allows patients with life-threatening diseases or conditions such as cancer try investigational medical products (drug, biologic, or medical device) when no satisfactory therapies are available and there is no opportunity for the patient to enroll in a clinical trial.</p> <p>Investigational medical products have not yet been approved by the FDA and the FDA has not found these products to be safe and effective for their specific use. The investigational medical products may, or may not, be effective in the treatment of the condition, and use of the product may cause serious side effects that were not expected.</p> <p>The request process can be complex to navigate, particularly for oncologists who don’t have experience working with clinical trials or these types of requests. To make a request, a member of the patient’s healthcare team will approach the pharmaceutical company to ask for its agreement that it will provide the medical product. The company has the right to approve or disapprove the physician’s request.</p> <p>The FDA Expanded Access Program allows a vast majority of these requests to proceed, and Project Facilitate is here to guide oncology healthcare providers through the process.</p>  <div class="facilitate_container"><span contenteditable="false" tabindex="-1"><img alt="background image" data-widget="image" src="/files/ProjectFacilitateBackgroundNoText_0.jpg"></span> <div class="centered"> <h3>Health Care Providers or Health Regulatory Professionals</h3> <p>For questions, please call <strong><span>Project Facilitate</span></strong> at <strong><span>(240)402-0004</span></strong> (M-F, 8:00am to 4:30pm, ET) or email Expanded Access Requests to:<strong> <a href="mailto:OncProjectFAcilitate@fda.hhs.gov">OncProjectFacilitate@fda.hhs.gov</a></strong></p> </div> </div>  <h4>To learn more about Project Facilitate please enjoy this short video (less than 90 seconds) </h4> <p class="text-align-center"><iframe allow="accelerometer; autoplay; encrypted-media; gyroscope; picture-in-picture" allowfullscreen class="embed-responsive-item" frameborder="0" height="315" src="https://www.youtube.com/embed/dhLW3LAEc9k" width="560"></iframe></p> <hr> <h4>Project Facilitate Contact Information </h4> <h5>Healthcare Providers or Regulatory Professionals </h5> <ul> <li> <p>Project Facilitate: <strong>(240) 402-0004</strong><span contenteditable="false" tabindex="-1"><a data-widget="image" href="#" style="margin: 0px; border: currentColor; border-image: none; left: 0px; top: 0px; width: 16px; height: 16px; right: 0px; bottom: 0px; overflow: hidden; vertical-align: middle; float: none; display: inline; white-space: nowrap; position: static !important;" title="Call: 866-300-4374"><img alt src="data:image/png;base64,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" style="margin: 0px; border: currentColor; border-image: none; left: 0px; top: 0px; width: 16px; height: 16px; right: 0px; bottom: 0px; overflow: hidden; vertical-align: middle; display: inline; white-space: nowrap; position: static !important;" title="Call: 866-300-4374"></a></span>, Monday – Friday • 8:00am to 4:30pm ET</p> </li> <li> <p>After-hours Emergency Requests for all medical products (drugs, biologics & medical devices): call FDA's Emergency Call Center: <span id="cke_bm_1575S" style="display: none;"> </span><strong>866-300-4374</strong><span contenteditable="false" tabindex="-1"><a data-widget="image" href="#" style="margin: 0px; border: currentColor; border-image: none; left: 0px; top: 0px; width: 16px; height: 16px; right: 0px; bottom: 0px; overflow: hidden; vertical-align: middle; float: none; display: inline; white-space: nowrap; position: static !important;" title="Call: 866-300-4374"><img alt src="data:image/png;base64,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" style="margin: 0px; border: currentColor; border-image: none; left: 0px; top: 0px; width: 16px; height: 16px; right: 0px; bottom: 0px; overflow: hidden; vertical-align: middle; display: inline; white-space: nowrap; position: static !important;" title="Call: 866-300-4374"></a></span> Monday – Friday after 4:30pm ET, and Weekends</p> </li> </ul> <h5>Project Facilitate Expanded Access Request Submission Information</h5> <p>Please <strong>email</strong> your expanded access requests to Project Facilitate:<strong> <a href="mailto:OncProjectFacilitate@fda.hhs.gov">OncProjectFacilitate@fda.hhs.gov</a>.</strong></p> <hr> <h5><strong>Patients and Families </strong></h5> <p>For questions, please call FDA’s Division of Drug Information at 301-796-3400<span contenteditable="false" tabindex="-1"><a data-widget="image" href="#" style="margin: 0px; border: currentColor; border-image: none; left: 0px; top: 0px; width: 16px; height: 16px; right: 0px; bottom: 0px; overflow: hidden; vertical-align: middle; float: none; display: inline; white-space: nowrap; position: static !important;" title="Call: 301-796-3400"><img alt src="data:image/png;base64,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" style="margin: 0px; border: currentColor; border-image: none; left: 0px; top: 0px; width: 16px; height: 16px; right: 0px; bottom: 0px; overflow: hidden; vertical-align: middle; display: inline; white-space: nowrap; position: static !important;" title="Call: 301-796-3400"></a></span> or email <a href="mailto:druginfo@fda.hhs.gov">druginfo@fda.hhs.gov</a>.</p> <hr> <h4><strong>Listen to a patient with cancer describe how Project Facilitate helped her receive an investigational therapy.</strong></h4> <p class="text-align-center"><iframe allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture" allowfullscreen frameborder="0" height="315" src="https://www.youtube.com/embed/AX7LQSYe6VE" title="YouTube video player" width="560"></iframe></p> <hr> <h4>For more information</h4> <ul> <li><a href="/about-fda/fda-pharmacy-student-experiential-program/overview-fdas-project-facilitate-oncology-expanded-access-program">An Overview of FDA’s Project Facilitate Oncology Expanded Access Program</a></li> <li><a href="https://youtu.be/cp0mBq52D1w">Three-minute video on Project Facilitate</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="51523635-1e85-4ed3-a96d-73791809ec2c" href="/news-events/public-health-focus/expanded-access" title="Expanded Access">FDA Expanded Access Program </a></li> <li><a href="http://navigator.reaganudall.org/expanded-access-navigator">Reagan-Udall Foundation Expanded Access Navigator</a></li> <li><a href="https://erequest.navigator.reaganudall.org/#/home/landing">Reagan-Udall Foundation Expanded Access eRequest (Physicians) </a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="40daaf30-d9ed-47d9-862d-f39b942bb218" href="/drugs/information-health-care-professionals-drugs/fda-drug-info-rounds-video" title="FDA Drug Info Rounds Video">FDA Drugs Info Rounds Videos</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="f6c612ec-6804-493a-91f5-8da9b1d682f3" href="/news-events/fda-meetings-conferences-and-workshops/project-facilitate-ea-navigator-fda-oce-and-reagan-udall-foundation-working-together-enable-patient" title="Project Facilitate & EA Navigator: FDA OCE and Reagan-Udall Foundation: Working Together to Enable Patient Access to Investigational Oncology Drugs - 05/16/2019 - 05/16/2019">Enhancing the Single Patient IND Process for Oncology Health Care Providers Public Workshop</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="70fc17f3-b114-43c6-a27e-d40fd23ac95a" href="/news-events/press-announcements/fda-announces-project-facilitate-assist-physicians-seeking-access-unapproved-therapies-patients" title="FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer">Press Announcement: FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer</a></li> </ul> <p class="text-align-center"> </p> <p> </p> <style type="text/css">/* Container holding the image and the text */ .facilitate_container { position: relative; text-align: center; color: black; } .facilitate_container img { width:100%; height: 10rem; } /* Bottom left text */ .bottom-left { position: absolute; bottom: 8px; left: 16px; } 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