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</ul> </div> </div> </div> </header> <div class="top-bar"> <div class="container"> <header class="page-header"> <h1 class="page-title"><span class="vcard">Mark Arnold</span></h1> </header><!-- .page-header --> <div class="breadcrumb-wrapper"> <div id="crumbs" itemscope itemtype="http://schema.org/BreadcrumbList"> <span itemprop="itemListElement" itemscope itemtype="http://schema.org/ListItem"> <a itemprop="item" href="https://ddblog.labcorp.com"><span itemprop="name">Home</span></a> <meta itemprop="position" content="1" /> <span class="separator">/</span> </span><span class="current" itemprop="itemListElement" itemscope itemtype="http://schema.org/ListItem"><a itemprop="item" href="https://ddblog.labcorp.com/author/markarnoldcvd/"><span itemprop="name">Mark Arnold</span></a><meta itemprop="position" content="2" /></span></div></div><!-- .breadcrumb-wrapper --> </div> </div> <div class="container main-content"> <div id="content" class="site-content"> <div class="row"> <div id="primary" class="content-area"> <main id="main" class="site-main"> <div class="row"> <article id="post-5005" class="post-5005 post type-post status-publish format-standard has-post-thumbnail hentry category-biomarkers category-device category-phase-iib-iii tag-bioanalytical-services tag-biomarkers latest_post" itemscope itemtype="https://schema.org/Blog"> <a href="https://ddblog.labcorp.com/2019/01/impact-to-the-bioanalytical-community-of-the-fda-issuance-of-the-draft-guidance-on-biomarker-qualification-evidentiary-framework/" class="post-thumbnail"><img width="250" height="182" src="https://ddblog.labcorp.com/wp-content/uploads/2019/07/21.jpg" class="attachment-blossom-feminine-cat size-blossom-feminine-cat wp-post-image" alt="Image of Hand Pressing Futuristic Tablet" data-attachment-id="5006" data-permalink="https://ddblog.labcorp.com/2019/01/impact-to-the-bioanalytical-community-of-the-fda-issuance-of-the-draft-guidance-on-biomarker-qualification-evidentiary-framework/attachment/21/" 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href="/cdn-cgi/l/email-protection#f3cca0869199969087ceba9e83929087d6c1c3879cd6c1c3879b96d6c1c3919a9c929d929f8a879a90929fd6c1c3909c9e9e869d9a878ad6c1c39c95d6c1c3879b96d6c1c3b5b7b2d6c1c39a808086929d9096d6c1c39c95d6c1c3879b96d6c1c39781929587d6c1c394869a97929d9096d6c1c39c9dd6c1c3919a9c9e9281989681d6c1c38286929f9a959a9092879a9c9dc9d6c1c396859a97969d879a92818ad6c1c39581929e96849c8198d5d0c3c0cbc8b19c978ace9b87878380c9dcdc9797919f9c94dd9f9291909c8183dd909c9edcc1c3c2cadcc3c2dc9a9e83929087de879cde879b96de919a9c929d929f8a879a90929fde909c9e9e869d9a878ade9c95de879b96de959792de9a808086929d9096de9c95de879b96de9781929587de94869a97929d9096de9c9dde919a9c9e9281989681de8286929f9a959a9092879a9c9dde96859a97969d879a92818ade9581929e96849c8198dc" rel="nofollow" target="_blank"><i class="fa fa-envelope" aria-hidden="true"></i></a></li> </ul> </div> </div> </div><h2 class="entry-title" itemprop="headline"><a href="https://ddblog.labcorp.com/2019/01/impact-to-the-bioanalytical-community-of-the-fda-issuance-of-the-draft-guidance-on-biomarker-qualification-evidentiary-framework/" rel="bookmark">Impact to the bioanalytical community of the FDA issuance of the draft guidance on biomarker qualification: evidentiary framework</a></h2><div class="entry-meta"><span class="byline" itemprop="author" itemscope itemtype="https://schema.org/Person"> by <span class="author vcard" itemprop="name"><a class="url fn n" href="https://ddblog.labcorp.com/author/markarnoldcvd/">Mark Arnold</a></span></span><span class="posted-on"><span class="text-on">updated on </span><a href="https://ddblog.labcorp.com/2019/01/impact-to-the-bioanalytical-community-of-the-fda-issuance-of-the-draft-guidance-on-biomarker-qualification-evidentiary-framework/" rel="bookmark"><time class="entry-date published updated" datetime="2020-06-02T17:01:19-04:00" itemprop="dateModified">Tuesday, June 2, 2020</time><time class="updated" datetime="2019-01-31T13:02:40-05:00" itemprop="datePublished">Thursday, January 31, 2019</time></a></span></div><!-- .entry-meta --> </header><!-- .entry-header home--> <div class="entry-content" itemprop="text"> <p>The FDA released a Draft Guidance in December (2018) on the evidentiary framework and standards required to achieve qualified biomarkers. It is intended to cover a regulatory gap related to the use of biomarkers outside of specific drug programs. As such, this Draft Guidance supports the Qualification of Drug Development Tools … </p> </div><!-- .entry-content --> <footer class="entry-footer"> </footer><!-- .entry-footer home--> </div><!-- .text-holder --> </article><!-- #post-5005 --> </div> <div class="pagination"></div> </main><!-- #main --> </div><!-- #primary --> </div><!-- .row/not-found --> </div><!-- #content --> </div><!-- .container/.main-content --> <footer id="colophon" class="site-footer" itemscope itemtype="http://schema.org/WPFooter"> <div class="site-info"> <div class="container"> <span class="copyright">Copyright © 2022 Labcorp All rights reserved.</span> </div> </div> </footer><!-- #colophon --> <button aria-label="go to top" id="blossom-top"> <span><i class="fa fa-angle-up"></i>TOP</span> </button> </div><!-- #page --> <script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script><script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/all.min.js?ver=5.6.3'></script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/v4-shims.min.js?ver=5.6.3'></script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/sticky-kit.min.js?ver=1.1.3'></script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/owl.carousel.min.js?ver=2.2.1'></script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/owl.carousel.aria.min.js?ver=2.0.0'></script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/jquery.matchHeight.min.js?ver=0.7.2'></script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/wow.min.js?ver=1.1.3'></script> <script type='text/javascript'> /* <![CDATA[ */ var bfp_data = {"lightbox":"","auto":"","loop":"","speed":"3000","animation":"fadeOut","child":"default","sticky":"","sticky_widget":"","header":"eight","url":"https:\/\/ddblog.labcorp.com\/wp-admin\/admin-ajax.php","rtl":""}; /* ]]> */ </script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/custom.min.js?ver=2.3.3'></script> <script type='text/javascript'> /* <![CDATA[ */ var bfp_ajax = {"url":"https:\/\/ddblog.labcorp.com\/wp-admin\/admin-ajax.php","startPage":"1","maxPages":"1","nextLink":null,"autoLoad":"load_more","loadmore":"Load More Posts","loading":"Loading...","nomore":"No More Post","layouts":"two-col-right","plugin_url":"https:\/\/ddblog.labcorp.com\/wp-content\/plugins"}; /* ]]> */ </script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/ajax.min.js?ver=2.3.3'></script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-includes/js/wp-embed.min.js?ver=5.4'></script> <script type="text/javascript"> if(typeof _satellite !== "undefined"){ _satellite.pageBottom(); } </script> </body> </html>