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Accelerated approval: Bringing patients access to needed medicines | PhRMA
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This pathway has provided timely access to treatments for HIV/AIDS, cancers and rare diseases, leading to better health outcomes for millions of patients. Learn more about the accelerated approval pathway in this fact sheet from PhRMA. " property="og:description" /><meta content="https://phrma.org:443/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Refresh/Banners/AcccelApprovalTeaser775.png" property="og:image" /><meta content="Accelerated approval: Bringing patients access to needed medicines" property="og:title" /><meta content="https://phrma.org/resource-center/Topics/Access-to-Medicines/Accelerated-approval-Bringing-patients-access-to-needed-medicines" property="og:url" /> <meta content="https://phrma.org:443/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Refresh/Banners/AccelApprovalTeaser635.jpg" property="twitter:image" /><meta content="The accelerated approval pathway, formally established by U.S. Food and Drug Administration (FDA) regulations in 1992 and later codified in statute in 1997, enables expedited access to medicines that address an unmet medical need for serious and life-threatening diseases and conditions, while preserving FDA’s high standards for safety and effectiveness. This pathway has provided timely access to treatments for HIV/AIDS, cancers and rare diseases, leading to better health outcomes for millions of patients." property="twitter:description" /><meta content="Accelerated Approval: Bringing Patients Access to Needed Medicines" property="twitter:title" /><meta content="summary_large_image" property="twitter:card" /> <meta name="viewport" content="width=device-width, initial-scale=1"/> <link rel="canonical" href="https://phrma.org/resource-center/Topics/Access-to-Medicines/Accelerated-approval-Bringing-patients-access-to-needed-medicines"> </head> <body class="default-device bodyclass"> <div class="component modal-container cookie-management"> <div class="component-content"> <div class="container modal-editor show-in-ee text-center "><div class="text-primary-navy">Modal Container (Shows only in EE)</div><span class="text-primary-navy">Modal ID: #</span>cookie-management-modal<a title="Cookie Management Container" href="/Data/Modal-Container-Folder/Cookie-Management-Container"><a data-target="cookie-management-modal" href="#"><div><div class="open-modal">Open Modal <i class="icon-plus-square"></i></div> <div class="close-modal d-none">Close Modal <i class="icon-minus-square"></i></div></div></a></a></div><div class="modal fade modal-section" id="cookie-management-modal" tabindex="-1" role="dialog" aria-labelledby="cookieManagementModal" aria-hidden="true"><div class="cookie-management__dialog modal-dialog" role="document"> <div class="component promo modal-content"> <div class="component-content"> <div class="cookie-management__header modal-header"><div class="cookie-management__top-section col-12"><div class="cookie-management__logo-container col-4 col-sm-2"><img src="/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Refresh/Common/phrma-logo-blue.svg" alt="PhRMA.org Logo"></img></div><div class="cookie-management__title-container col-6 col-sm-8"><h5 class="modal-title field-title" id="modalLabel">Manage My Cookies</h5></div><button class="close" type="button" data-dismiss="modal" aria-label="Close"><span aria-hidden="true">×</span></button></div><div class="cookie-management__description-section"><div class="cookie-management__rich-text field-description"><p>Your privacy is important to us. 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<div class="jump-link-text d-none field-jump-nav-link-text"></div><div class="container"><div class="basic-content-header text-center"><h4 class="sup-headline text-gray-300 field-basiccontentsupheadline"></h4><h4 class="sup-headline text-gray-300 field-basiccontentsupheadlinelink"></h4><h2 class="headline field-basiccontentheadline"></h2><h4 class="sub-headline text-gray-300 field-basiccontentsubheadline"></h4></div><section class="row"><div class="img-container d-none d-lg-block col-6"><img src="/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Refresh/Banners/AcccelApprovalTeaser775.png?w=570&hash=40E5AF9502FB377576C56C768D2FE725" alt="Accelerated Approval: Bringing Patients Access to Needed Medicines" sizes="(max-width: 768px) 738px, 570px" srcset="/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Refresh/Banners/AcccelApprovalTeaser775.png?w=738&hash=B6DA884385E6DFCB07C225B1FBBE364F 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