Oncology Center of Excellence

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href="/about-fda/oncology-center-excellence/project-community" class="lcds-section-nav__section-link lcds-section-nav__link">Project Community</a></li> </ul> </div> </div> </div> </div> </li> </ul> </nav> </section> <section id="block-entityviewcontent-15" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <ol class="lcds-breadcrumb visible-md visible-lg"> <li > <a href="/">Home</a> </li> <li > <a href="/about-fda">About FDA</a> </li> <li > <a href="/about-fda/fda-organization">FDA Organization</a> </li> <li > <a class="current-link">Oncology Center of Excellence</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/about-fda/fda-organization" title="FDA Organization"> FDA Organization </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-13" 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="text-center content-title">Oncology Center of Excellence </h1> <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%2Ffda-organization%2Foncology-center-excellence" 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=Oncology%20Center%20of%20Excellence&url=https://www.fda.gov%2Fabout-fda%2Ffda-organization%2Foncology-center-excellence" 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 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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/OCE_WebMainRedWhiteBlueRibbonGreyVissionMissionFINAL1.20.22_1.jpg?itok=J5HEdXVI 1x" media="all and (max-width: 320px)" type="image/jpeg" width="320" height="180"/> <source srcset="/files/styles/main_image_medium/public/OCE_WebMainRedWhiteBlueRibbonGreyVissionMissionFINAL1.20.22_1.jpg?itok=Gw-UGuMx 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/OCE_WebMainRedWhiteBlueRibbonGreyVissionMissionFINAL1.20.22_1.jpg?itok=Gw-UGuMx 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/OCE_WebMainRedWhiteBlueRibbonGreyVissionMissionFINAL1.20.22_1.jpg?itok=Gw-UGuMx 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/OCE_WebMainRedWhiteBlueRibbonGreyVissionMissionFINAL1.20.22_1.jpg?itok=QPKzzV4e 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/OCE_WebMainRedWhiteBlueRibbonGreyVissionMissionFINAL1.20.22_1.jpg?itok=QPKzzV4e 1x" media="all and (min-width: 1201px)" type="image/jpeg" width="1020" height="574"/> <img loading="eager" src="/files/styles/main_image_medium/public/OCE_WebMainRedWhiteBlueRibbonGreyVissionMissionFINAL1.20.22_1.jpg?itok=Gw-UGuMx" width="500" height="281" alt="OCE Mission Vision" class="img-responsive" /> </picture> </div> </div> </div> </figure> <hr> <p><h2 class="text-align-center">Connect With Us!</h2> <h5 class="text-align-center">X: <a href="https://twitter.com/FDAOncology">@FDAOncology</a> • Email:<a href="mailto:FDAOncology@fda.hhs.gov"> FDAOncology@fda.hhs.gov</a></h5> <p>The Oncology Center of Excellence (OCE) was authorized by the 21st Century Cures Act of 2016 and established on January 19, 2017. The Center unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies. The OCE also leads a variety of research and educational outreach projects and programs to advance the development and regulation of medical products for patients with cancer.</p> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="5b48eb48-ac9b-40d6-873a-2ed59690e1de" href="/about-fda/oncology-center-excellence/who-we-are-oncology-center-excellence" title="Who We Are - Oncology Center of Excellence">Who We Are</a> – Oncology Center of Excellence</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="5600221b-7448-46c6-b869-bf6867a67ee2" href="/about-fda/center-drug-evaluation-and-research-cder/information-sponsors-submissions-office-oncologic-diseases-ood" title="Information for Sponsors: Submissions to the Office of Oncologic Diseases (OOD)">Information for Sponsors</a> – Submissions to the Office of Oncologic Diseases</li> </ul> <p>To learn more about the Oncology Center of Excellence, please check out our <strong><a href="/about-fda/oncology-center-excellence/oce-annual-reports">OCE Annual Reports</a>. </strong></p> <div class=" panel-group" id="accordion_346166" role="tablist" aria-multiselectable="true"> <div open="no" title="News, Events & Approvals" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_6746352253102"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#6746352253102" aria-controls="6746352253102">News, Events & Approvals</a> </h2> </div> <div id="6746352253102" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_6746352253102"> <div class="panel-body"> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="cb431af8-c1cf-4cb0-ab51-bf2e9651e628" href="/about-fda/oncology-center-excellence/oce-meetings-and-workshops" title="OCE Meetings and Workshops">Upcoming OCE Meetings and Workshops</a></p> <p><a href="/about-fda/oncology-center-excellence/oce-public-presentations">OCE Public Presentations</a></p> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="463b0d4d-9e98-4142-a880-97cb541ad249" href="/advisory-committees/human-drug-advisory-committees/oncologic-drugs-advisory-committee" title="Oncologic Drugs Advisory Committee">Oncologic Drugs Advisory Committee</a></p> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="a4f78481-4f17-48d4-869f-0179fd26f776" href="/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications" title="Oncology (Cancer)/Hematologic Malignancies Approval Notifications">Oncology/Hematologic Malignancies Approvals</a></p> <ul> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4632d886-88f7-456e-aa36-ccb72756c680" href="/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals" title="Ongoing | Cancer Accelerated Approvals">Ongoing | Cancer Accelerated Approvals</a></p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="e7af64e4-b9b3-4761-9cc8-90bf45d54bcb" href="/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals" title="Verified Clinical Benefit | Cancer Accelerated Approvals">Verified Clinical Benefit | Cancer Accelerated Approvals</a></p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="7c7fc519-1b7e-44cc-8e3d-d5a31db9c130" href="/drugs/resources-information-approved-drugs/withdrawn-cancer-accelerated-approvals" title="Withdrawn | Cancer Accelerated Approvals ">Withdrawn | Cancer Accelerated Approvals</a></p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c4355745-a6b9-44cc-afaf-e29099deb8f8" href="/drugs/resources-information-approved-drugs/drug-information-soundcast-clinical-oncology-disco" title="Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)">Drug Information Soundcast in Clinical Oncology</a> – Short podcasts on oncology product approvals </p> </li> </ul> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ed12243a-aaa1-437d-be83-5fdcd8e3bd26" href="/about-fda/oncology-center-excellence/oncology-center-excellence-guidance-documents" title="Oncology Center of Excellence Guidance Documents">Oncology Guidance</a> – OCE-led FDA guidance documents on oncology topics</p> <p><a href="//www.fda.gov/about-fda/oncology-center-excellence/oce-programs-and-projects-overview">OCE Programs and Projects Overview</a> – A Comprehensive List</p> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="0be11790-04bc-4bc3-89d4-6f2d21d8a700" href="/about-fda/oncology-center-excellence/oce-publications" title="OCE Publications">OCE Publications</a></p> <p><a href="/about-fda/oncology-center-excellence/oce-pooled-analysis-publications">OCE Pooled Analysis Publications</a></p> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="5db023c5-e4c8-4285-959d-b4d8c6221419" href="/about-fda/center-drug-evaluation-and-research-cder/requesting-cder-speaker" title="Requesting a CDER Speaker">Request an OCE Speaker</a></p> </div> </div> </div> <div title="Community Resources" class=" panel panel-default"> <div class="panel-heading" role="tab" id="heading_6746352253c6b"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#6746352253c6b" aria-controls="6746352253c6b">Community Resources</a> </h2> </div> <div id="6746352253c6b" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_6746352253c6b"> <div class="panel-body"> <p><a data-entity- href="/about-fda/oncology-center-excellence/project-community">Project Community</a> – Empowering patients with cancer, survivors, advocates and consumers</p> <ul> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="92817d9f-762f-44bc-9676-35d78b530053" href="/about-fda/project-community/conversations-cancer" title="Conversations on Cancer">Conversations on Cancer</a> – OCE’s public panel discussion series, making cancer personal</p> </li> <li> <p><a href="/about-fda/project-community/oce-engage-project-community-newsletter">OCE ENGAGE: A Project Community Newsletter</a> </p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="78720d7e-889c-4008-bf53-6e97d7d6b4fc" href="/about-fda/project-community/national-black-family-cancer-awareness" title="National Black Family Cancer Awareness">National Black Family Cancer Awareness</a></p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="88f9210d-60c0-410a-b1cf-512793ed157c" href="/about-fda/project-community/national-hispaniclatino-family-cancer-awareness" title="National Hispanic/Latino Family Cancer Awareness ">National Hispanic/Latino Family Cancer Awareness</a></p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="7d61b94a-ec52-46aa-aa2d-5438faf49ab1" href="/about-fda/project-community/concientizacion-nacional-sobre-el-cancer-en-las-familias-hispanaslatinas" title="Concientización Nacional sobre el Cáncer en las Familias Hispanas/Latinas">Concientización Nacional sobre el Cáncer en las Familias Hispanas/Latinas</a></p> </li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="56daac77-aa05-4326-a126-e9ba7974a103" href="/about-fda/project-community/programa-nacional-de-conscientizacao-sobre-o-cancer-em-familias-hispanicaslatinas" title="Programa Nacional de Conscientização sobre o Câncer em Famílias Hispânicas/Latinas">Programa Nacional de Conscientização sobre o Câncer em Famílias Hispânicas/Latinas</a></li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="47cee524-6567-439d-a95b-a150c8b42bc6" href="/about-fda/project-community/cancer-community-resources" title="Cancer Community Resources">Cancer Community Resources</a></p> </li> </ul> </div> </div> </div> <div title="Healthcare Professional Resources" class=" panel panel-default"> <div class="panel-heading" role="tab" id="heading_6746352253d1c"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#6746352253d1c" aria-controls="6746352253d1c">Healthcare Professional Resources</a> </h2> </div> <div id="6746352253d1c" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_6746352253d1c"> <div class="panel-body"> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="12a1f063-8553-4ef8-b807-8650f0fad690" href="/about-fda/scientific-careers-fda/jobs-oncologyhematology" title="Jobs in Oncology/Hematology">Careers in Oncology/Hematology</a></p> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="01bcc349-f8ca-4d29-90d5-8f173cb85bf2" href="/about-fda/oncology-center-excellence/project-facilitate" title="Project Facilitate ">Project Facilitate</a><a href="/about-fda/oncology-center-excellence/project-facilitate"> </a>– Assisting oncology providers with expanded access requests</p> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4e4be0a7-2105-412a-b89b-39c63bd5a031" href="/about-fda/oncology-center-excellence/project-renewal" title="Project Renewal">Project Renewal</a> – Labeling updates for older oncology products</p> <ul> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="28d9e336-54cb-4a42-84a2-fd69a4436886" href="/about-fda/oncology-center-excellence/about-oncology-prescription-drug-labeling" title="About Oncology Prescription Drug Labeling">About Oncology Prescription Drug Labeling</a></p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="3b7dca48-a360-4171-a4b8-6d6b773ca1a7" href="/about-fda/oncology-center-excellence/how-do-i-use-prescription-drug-labeling" title="How Do I Use Prescription Drug Labeling">How Do I Use Prescription Drug Labeling</a></p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="dea084fd-30f1-4422-82af-6a82bd32a159" href="/about-fda/oncology-center-excellence/project-renewal-faq" title="Project Renewal FAQ">Project Renewal FAQ</a></p> </li> </ul> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="a20f242b-ad27-4bed-9c6f-d97c946d0b4b" href="/about-fda/oncology-center-excellence/project-socrates" title="Project Socrates ">Project Socrates</a> – An educational network for oncology product development</p> <ul> <li> <p><a href="/about-fda/oncology-center-excellence/oce-pulse-oce-oncology-news">OCE PULSE: OCE Oncology News</a> – A monthly newsletter for oncology/hematology fellows and fellowship program directors</p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="156dd820-094e-4932-9b66-98551ba7ed7d" href="/about-fda/oncology-center-excellence/project-livin-label" title="Project Livin’ Label">Project Livin' Label </a>– Labeling unfolded, knowledge released</p> </li> <li> <p><a href="/about-fda/oce-regulatory-science-online-lecture-series">OCE Regulatory Science Online Lecture Series</a> – On-demand webinars about oncology product development and clinical trials</p> </li> <li> <p><a href="https://www.cancer.gov/grants-training/training/at-nci/iotf">Interagency Oncology Task Force Fellowship</a></p> </li> </ul> </div> </div> </div> <div title="Oncology Regulatory Affairs and Policy Program" class=" panel panel-default"> <div class="panel-heading" role="tab" id="heading_6746352253db0"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#6746352253db0" aria-controls="6746352253db0">Oncology Regulatory Affairs and Policy Program</a> </h2> </div> <div id="6746352253db0" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_6746352253db0"> <div class="panel-body"> <p><a href="/about-fda/oncology-center-excellence/oncology-regulatory-affairs-and-policy-program">Oncology Regulatory Affairs and Policy Program</a> – Cross-center coordination of oncology product clinical review</p> <ul> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="537b8ae9-835c-4c43-ac90-66fbd899683d" href="/about-fda/oncology-center-excellence/advancing-oncology-decentralized-trials" title="Advancing Oncology Decentralized Trials">Advancing Oncology Decentralized Trials</a> – Learning from COVID-19 trial datasets</p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="9dc46ef8-c7b8-4796-93c5-061f3a8cc094" href="/about-fda/oncology-center-excellence/electronic-case-report-form-initiative" title="Electronic Case Report Form Initiative">Electronic Case Report Form Initiative</a> – COVID-19-related data elements</p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="478ad3f4-a9cd-4c4f-be80-bae041e97035" href="/about-fda/oncology-center-excellence/assessment-aid" title="Assessment Aid">OCE Assessment Aid</a></p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ef81eabe-4118-4098-9f5b-7caac2a103d8" href="/about-fda/oncology-center-excellence/real-time-oncology-review" title="Real-Time Oncology Review">OCE Real-Time Oncology Review</a></p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="7e55cf91-7adf-41f2-98c9-b839cdfe05e1" href="/about-fda/oncology-center-excellence/project-pointcounterpoint" title="Project Point/Counterpoint">Project Point/Counterpoint </a>– Increasing transparency of viewpoints for the oncologic drugs advisory committee</p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="9f1b5c29-032b-4e15-8753-e2ba65c9df18" href="/about-fda/oncology-center-excellence/project-confirm" title="Project Confirm">Project Confirm</a> – Promoting the transparency of accelerated approval for oncology indications</p> </li> </ul> </div> </div> </div> <div title="Product-Specific Programs" class=" panel panel-default"> <div class="panel-heading" role="tab" id="heading_6746352253e3f"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#6746352253e3f" aria-controls="6746352253e3f">Product-Specific Programs</a> </h2> </div> <div id="6746352253e3f" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_6746352253e3f"> <div class="panel-body"> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="5f7ad53f-32b3-4bf7-a3f2-3efb82efcfd2" href="/about-fda/oncology-center-excellence/immuno-oncology" title="Immuno-Oncology">Immuno-Oncology Program </a></p> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="aeb65d2b-7fae-4f43-94c3-11f063731892" href="/about-fda/oncology-center-excellence/oncology-cell-and-gene-therapy" title="Oncology Cell and Gene Therapy">Oncology Cell and Gene Therapy Program</a></p> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ebcfd090-9774-424e-8a0d-6d9f5f499ced" href="/about-fda/oncology-center-excellence/precision-oncology-program" title="Precision Oncology Program">Precision Oncology Program </a></p> </div> </div> </div> <div title="Oncology Real World Evidence Program" class=" panel panel-default"> <div class="panel-heading" role="tab" id="heading_6746352253eca"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#6746352253eca" aria-controls="6746352253eca">Oncology Real World Evidence Program</a> </h2> </div> <div id="6746352253eca" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_6746352253eca"> <div class="panel-body"> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1bc227da-e734-45cf-a2d6-054dfdcb5b65" href="/about-fda/oncology-center-excellence/oncology-real-world-evidence-program" title="Oncology Real World Evidence Program">Oncology Real World Evidence Program</a> – Fostering science and collaboration to translate real world data into real world evidence</p> <ul> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c0429541-1020-4e80-a05e-59d0090e5070" href="/about-fda/oncology-center-excellence/oncology-quality-characterization-and-assessment-real-world-data-qcard-initiative" title="Oncology Quality, Characterization and Assessment of Real-World Data (QCARD) Initiative">Oncology Quality, Characterization and Assessment of Real-World Data (QCARD) Initiative</a></p> </li> </ul> </div> </div> </div> <div title="Patient-Focused Drug Development Program" class=" panel panel-default"> <div class="panel-heading" role="tab" id="heading_6746352253f55"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#6746352253f55" aria-controls="6746352253f55">Patient-Focused Drug Development Program</a> </h2> </div> <div id="6746352253f55" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_6746352253f55"> <div class="panel-body"> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="e266c03e-5674-4dbb-aef5-22d552ff507f" href="/about-fda/oncology-center-excellence/patient-focused-drug-development" title="Patient-Focused Drug Development">Patient-Focused Drug Development Program</a> – Patient outcomes research in cancer populations</p> <ul> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="cfcce3dd-fdee-403c-a99c-75d9d3c2baba" href="/about-fda/oncology-center-excellence/project-patient-voice" title="Project Patient Voice">Project Patient Voice</a></p> </li> </ul> </div> </div> </div> <div title="Pediatric Oncology and Rare Cancers Programs" class=" panel panel-default"> <div class="panel-heading" role="tab" id="heading_6746352253fec"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#6746352253fec" aria-controls="6746352253fec">Pediatric Oncology and Rare Cancers Programs</a> </h2> </div> <div id="6746352253fec" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_6746352253fec"> <div class="panel-body"> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="96784f46-8f41-4afb-b2ce-fa934cc19a46" href="/about-fda/oncology-center-excellence/pediatric-oncology" title="Pediatric Oncology">Pediatric Oncology Program </a>– Promoting the development of drugs and biologics to treat cancer in children</p> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="10638997-ca0f-4470-a32b-afe9550d058d" href="/about-fda/oncology-center-excellence/pediatric-oncology-drug-approvals" title="Pediatric Oncology Drug Approvals">Pediatric Oncology Drug Approvals</a></li> </ul> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="f3fdd3b2-f0e6-47fe-a607-15821ebedd97" href="/about-fda/oncology-center-excellence/oce-rare-cancers-program" title="OCE Rare Cancers Program">Rare Cancers Program</a> – Promoting the development of safe and effective new drugs and biologics to treat patients with rare cancers.  </p> </div> </div> </div> <div title="Cancer in Older Adults Program" class=" panel panel-default"> <div class="panel-heading" role="tab" id="heading_6746352254082"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#6746352254082" aria-controls="6746352254082">Cancer in Older Adults Program</a> </h2> </div> <div id="6746352254082" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_6746352254082"> <div class="panel-body"> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ff681d75-457c-4e5b-b72e-e3649988d58d" href="/about-fda/oncology-center-excellence/oce-cancer-older-adults-program" title="OCE Cancer in Older Adults Program">Cancer in Older Adults Program</a> – Improving outcomes for older adults with cancer through engagement and research. </p> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="93ff4ed6-3188-473d-9ec5-8f81e982c1d7" href="/about-fda/oncology-center-excellence/project-silver" title="Project Silver">Project Silver</a> – Improving the evidence base for the treatment of older adults with cancer.</p> </div> </div> </div> <div title="The OCE Equity Program" class=" panel panel-default"> <div class="panel-heading" role="tab" id="heading_674635225410c"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674635225410c" aria-controls="674635225410c">The OCE Equity Program</a> </h2> </div> <div id="674635225410c" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674635225410c"> <div class="panel-body"> <p><a href="/about-fda/oncology-center-excellence/oce-equity-program">The OCE Equity Program</a> – Improving access to clinical trials for historically underrepresented populations</p> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="14a91101-6aae-41eb-b930-7d08cd67e0ce" href="/about-fda/oncology-center-excellence/project-asiatica" title="Project ASIATICA">Project ASIATICA</a> – Bringing awareness to Asian American, Native Hawaiian, and Other Pacific Islander (AA & NHPI) patients with cancer</p> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="93ff4ed6-3188-473d-9ec5-8f81e982c1d7" href="/about-fda/oncology-center-excellence/project-silver" title="Project Silver">Project Silver</a> – Improving the evidence base for the treatment of older adults with cancer</p> </div> </div> </div> <div title="International Projects" class=" panel panel-default"> <div class="panel-heading" role="tab" id="heading_67463522541a2"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#67463522541a2" aria-controls="67463522541a2">International Projects</a> </h2> </div> <div id="67463522541a2" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_67463522541a2"> <div class="panel-body"> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="6ba93f36-fd43-4df6-9291-b4ac8a275a31" href="/about-fda/oncology-center-excellence/project-orbis" title="Project Orbis">Project Orbis</a> – Concurrent submission and review of oncology products among international partners.</p> <p><a href="/about-fda/oncology-center-excellence/project-asha">Project Asha</a> – Collaboration to increase cancer clinical trial access in India</p> </div> </div> </div> <div title="Clinical Regulatory Projects" class=" panel panel-default"> <div class="panel-heading" role="tab" id="heading_674635225422e"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674635225422e" aria-controls="674635225422e">Clinical Regulatory Projects</a> </h2> </div> <div id="674635225422e" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674635225422e"> <div class="panel-body"> <p><a href="/about-fda/oncology-center-excellence/project-endpoint">Project Endpoint</a> – Advancing the use of endpoints in oncology drug development</p> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="12a34f3d-7069-410f-9896-81c06ddc775f" href="/about-fda/oncology-center-excellence/project-frontrunner" title="Project FrontRunner ">Project FrontRunner</a> – Advancing Development of New Oncology Therapies to the Early Clinical Setting</p> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="95f53d5e-5980-444c-ac0e-db7355a19272" href="/about-fda/oncology-center-excellence/project-optimus" title="Project Optimus">Project Optimus</a> – Reforming the dose optimization and dose selection paradigm in oncology drug development</p> </div> </div> </div> <div title="Research & Development Projects" class=" panel panel-default"> <div class="panel-heading" role="tab" id="heading_67463522542b9"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#67463522542b9" aria-controls="67463522542b9">Research & Development Projects</a> </h2> </div> <div id="67463522542b9" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_67463522542b9"> <div class="panel-body"> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="be69095e-ea8b-4303-ab09-225eefc6e79f" href="/about-fda/oncology-center-excellence/project-catalyst" title="Project Catalyst">Project Catalyst</a> – Fostering early-stage product innovation</p> <ul> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="0e17a9ba-f6e5-4055-a916-c8803462fcf8" href="/about-fda/oncology-center-excellence/oncology-regulatory-expertise-and-early-guidance-oreeg" title="Oncology Regulatory Expertise and Early Guidance (OREEG)">Oncology Regulatory Expertise and Early guidance (OREEG</a><a href="/about-fda/oncology-center-excellence/oncology-regulatory-expertise-and-early-guidance-oreeg">)</a> – Providing product-type advice to inform drug development decisions</p> </li> </ul> <p><a href="/about-fda/oncology-center-excellence/project-5-5">Project 5 in 5</a> crowdsourcing 5 clinically relevant questions for 5 pragmatic trials</p> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="0b6cd6d4-f99d-4ad3-a62d-521304ba6e44" href="/about-fda/oncology-center-excellence/project-pragmatica" title="Project Pragmatica">Project Pragmatica</a> – Advancing evidence generation for approved oncology medical products</p> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="a954f5cf-e942-4542-a23e-2c7be79285bd" href="/about-fda/oncology-center-excellence/oce-scientific-collaborative" title="OCE Scientific Collaborative">OCE Scientific Collaborative</a> – Applied research collaborations</p> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c17235bc-8bb3-4f6b-85c8-f02fe813bed9" href="/about-fda/oncology-center-excellence/oce-scientific-interest-areas" title="OCE Scientific Interest Areas">OCE Scientific Interest Areas</a></li> <li> <p><a href="/about-fda/oncology-center-excellence/oce-funded-active-extramural-research-projects">OCE-Funded Active Extramural Research Projects</a></p> </li> <li> <p><a href="/about-fda/oncology-center-excellence/fda-broad-agency-announcement-frequently-asked-questions-oncology-researchers">FDA Broad Agency Announcement: Frequently Asked Questions for Oncology Researchers</a></p> </li> </ul> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="e5bcf000-200b-4acd-9aa7-8a02a1c554d8" href="/about-fda/oncology-center-excellence/project-significant-statistics-cancer-trials" title="Project SignifiCanT: Statistics in Cancer Trials">Project Significant</a> – Collaboration and engagement among diverse stake holders to further design and analysis of cancer clinical trials</p> </div> </div> </div></div> <hr> <p> </p>  <div class="box-container"> <h2>Featured Projects and Events</h2> <div class="parent"> <article class="child"><span contenteditable="false" tabindex="-1"><img alt="Box 2" class="child__img" data-widget="image" src="https://www.fda.gov/files/styles/main_image_1/public/2023-CoCa-Web-Page-Banner-Narrow_3.jpg?itok=I3G1QXvb" width="11"></span> <div class="child__content"> <h3><a href="/about-fda/project-community/conversations-cancer">Conversations on Cancer</a></h3> <strong>November 19, 2024:  </strong><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1c03498a-64bf-476b-b8e6-0324154d5322" href="/news-events/fda-meetings-conferences-and-workshops/fda-oncology-center-excellence-presents-conversations-cancer-pediatric-cancers-navigating-challenges" title="FDA Oncology Center of Excellence Presents: Conversations on Cancer - Pediatric Cancers: Navigating the Challenges Together - 11/19/2024">Conversations on Cancer – Pediatric Cancers: Navigating the Challenges Together</a>9:30 AM - 10:30 pm ET <a href="https://www.surveymonkey.com/r/5TNRXV5">Registration</a></div> </article> <article class="child"><span contenteditable="false" tabindex="-1"><img alt="Box 2" class="child__img" data-widget="image" src="/files/ProjectConfirm.jpg"></span> <div class="child__content"> <h3><a href="/about-fda/oncology-center-excellence/project-confirm">Project Confirm</a></h3> Project Confirm is an initiative of the FDA Oncology Center of Excellence to promote the transparency of outcomes related to Accelerated Approvals for oncology indications.</div> </article> <article class="child"><span contenteditable="false" tabindex="-1"><img alt="Box 2" class="child__img" data-widget="image" src="/files/2_108.jpg"></span> <div class="child__content"> <h3><a href="/about-fda/oncology-center-excellence/project-orbis">Project Orbis</a></h3> Project Orbis provides a framework for concurrent submission and review of oncology products among international regulators, which may allow patients with cancer to receive earlier access to products.</div> </article>  <article class="child"><span contenteditable="false" tabindex="-1"><img alt="Box 2" class="child__img" data-widget="image" src="/files/ProjectOptimusCapsuleLinesOptimalPhotoshopfirstWebpagefinal.jpg"> </span> <div class="child__content"> <h3><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="95f53d5e-5980-444c-ac0e-db7355a19272" href="/about-fda/oncology-center-excellence/project-optimus" title="Project Optimus">Project Optimus</a></h3> An initiative to reform the dose optimization and dose selection paradigm in oncology drug development.</div> </article> </div> </div> <p> </p> <p><strong>OUR MISSION</strong>: The mission of the Oncology Center of Excellence is to achieve patient-centered regulatory decision-making through innovation and 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