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Development & Approval Process (CBER) | FDA

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<div> <ul class="lcds-section-nav__section-link__active lcds-section-nav__list"> <li><a href="/vaccines-blood-biologics/development-approval-process-cber/2024-biological-approvals" class="lcds-section-nav__link">2024 Biological Approvals</a></li> <li><a href="/vaccines-blood-biologics/development-approval-process-cber/2023-biological-approvals" class="lcds-section-nav__link">2023 Biological Approvals</a></li> <li><a href="/vaccines-blood-biologics/development-approval-process-cber/biological-approvals-year" class="lcds-section-nav__link">Biological Approvals by Year</a></li> <li><a href="/vaccines-blood-biologics/development-approval-process-cber/expanded-access-experimental-biologics" class="lcds-section-nav__link">Expanded Access to Experimental Biologics</a></li> <li><a href="/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101" class="lcds-section-nav__link">Vaccine Development – 101</a></li> </ul> </div> </div> </div> <div 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lcds-section-nav__link">Device Submissions for CBER-Regulated Products</a></li> <li><a href="/vaccines-blood-biologics/development-approval-process-cber/labeling-cber-regulated-products" class="lcds-section-nav__section-link lcds-section-nav__link">Labeling for CBER-Regulated Products</a></li> <li><a href="/vaccines-blood-biologics/development-approval-process-cber/master-files-cber-regulated-products" class="lcds-section-nav__section-link lcds-section-nav__link">Master Files for CBER-Regulated Products </a></li> <li><a href="/vaccines-blood-biologics/development-approval-process-cber/new-drug-application-nda-and-abbreviated-new-drug-application-anda-cber-regulated-products" class="lcds-section-nav__section-link lcds-section-nav__link">New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products</a></li> <li><a href="/vaccines-blood-biologics/development-approval-process-cber/formal-meetings-and-requests-feedback-cber-regulated-products" class="lcds-section-nav__section-link lcds-section-nav__link">Formal Meetings and Requests for Feedback for CBER-Regulated Products </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="/vaccines-blood-biologics">Vaccines, Blood &amp; Biologics</a> </li> <li > <a class="current-link">Development &amp; Approval Process (CBER)</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/vaccines-blood-biologics" title="Vaccines, Blood &amp; Biologics"> Vaccines, Blood &amp; Biologics </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-14" 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request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. <ul> <li><strong><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1bd3f0b4-efc8-4053-bf51-e1ed3585967a" href="/drugs/pharmaceutical-quality-resources/chemistry-manufacturing-and-controls-development-and-readiness-pilot-cdrp-program" target="_blank" title="Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program">Chemistry, Manufacturing, and Controls Development and Readiness (CDRP)</a></strong></li> </ul> </li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ae4298eb-f574-42b7-a3da-b4e8131a204d" href="/vaccines-blood-biologics/development-approval-process-cber/expanded-access-experimental-biologics" title="Expanded Access to Experimental Biologics">Expanded Access to Experimental Biologics</a><br> Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA).</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="3a2ed2b8-994b-4607-977f-73e0e72dafcf" href="/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber" title="Biologics License Applications (BLA) Process (CBER)">Biologics License Applications (BLA) Process (CBER)</a><br> The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). <ul> <li><strong><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="76522cd1-a730-4fe7-abdc-b22ea32e4e00" href="/drugs/development-resources/split-real-time-application-review-star" target="_blank" title="Split Real Time Application Review (STAR)">Split Real Time Application Review (STAR) 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for Biologics Evaluation and Research<br> Food and Drug Administration<br> 10903 New Hampshire Ave WO71-3103<br> Silver Spring, MD 20993-0002 <br> </p> <p></p> <a href="mailto:ocod@fda.hhs.gov" style="text-decoration: underline">ocod@fda.hhs.gov</a> <p></p> <p>(800) 835-4709<br> (240) 402-8010</p> <p></p> <p>For Updates on Twitter, follow <a href="https://twitter.com/fdacber" style="text-decoration: underline" target="_blank">@fdacber</a> </p> </div> <div class="lcds-contact__connect lcds-contact__connect--subtopic bg-white txt-dark"> <style>.lcds-contact__connect.bg-white a{color: #007CBA; text-decoration:underline;} .lcds-contact__connect.bg-white a:hover{text-decoration: none;}</style> <ul class="list-unstyled"> <li><a href="/vaccines-blood-biologics/resources-you-biologics">Resources for You (Biologics)</a></li> <li><a href="/about-fda/fda-organization/center-biologics-evaluation-and-research-cber">About the Center for Biologics Evaluation and Research (CBER)</a></li> <li><a href="/vaccines-blood-biologics/safety-availability-biologics/report-problem-center-biologics-evaluation-research">Report a Problem to the Center for Biologics Evaluation & Research</a></li> <li><a href="/vaccines-blood-biologics/safety-availability-biologics/recalls-biologics">Recalls (Biologics)</a></li> <li><a href="/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-shortages-and-discontinuations">CBER-Regulated Products: Shortages and Discontinuations</a></li> <li><a href="/vaccines-blood-biologics/biologics-products-establishments">Biologics Products & Establishments</a></li> </ul> </div> </section> </div> </div> </div> <br> </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top" > <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2023-08-04T20:24:00Z">08/04/2023</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Regulated Product(s)</h2> <ul role="menu" class="lcds-metadata-list"> <li role="menuitem">Biologics</li> </ul> </div> </li> </ul> </aside> </div> </section> </aside> <aside class="col-md-2 col-md-pull-10" role="complementary"> <section id="block-entityviewcontent-3" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <nav id="section-nav" class="lcds-card lcds-section-nav lcds-section-nav--side hidden-xs hidden-sm"> <ul class="lcds-section-nav__list lcds-section-nav--side__list"> <li> <a 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href="/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav--side__link">Biologics License Applications (BLA) Process (CBER)</a></li> <li><a href="/vaccines-blood-biologics/development-approval-process-cber/investigational-new-drug-applications-inds-cber-regulated-products" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav--side__link">Investigational New Drug Applications (INDs) for CBER-Regulated Products </a></li> <li><a href="/vaccines-blood-biologics/development-approval-process-cber/device-submissions-cber-regulated-products" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav--side__link">Device Submissions for CBER-Regulated Products</a></li> <li><a href="/vaccines-blood-biologics/development-approval-process-cber/labeling-cber-regulated-products" class="lcds-section-nav__section-link 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