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</ul> </div> </div> </div> </header> <div class="top-bar"> <div class="container"> <header class="page-header"> <h1 class="page-title">Med Device</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/tag/med-device/"><span itemprop="name">Med Device</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-7199" class="post-7199 post type-post status-publish format-standard has-post-thumbnail hentry category-commercialization category-device tag-med-device tag-reimbursement latest_post" itemscope itemtype="https://schema.org/Blog"> <a href="https://ddblog.labcorp.com/2020/08/developing-an-effective-reimbursement-strategy-if-you-build-it-will-they-come/" class="post-thumbnail"><img width="450" height="300" src="https://ddblog.labcorp.com/wp-content/uploads/2020/08/reimbblog-450x300.jpg" class="attachment-blossom-feminine-cat size-blossom-feminine-cat wp-post-image" alt="reimbblog" srcset="https://ddblog.labcorp.com/wp-content/uploads/2020/08/reimbblog-450x300.jpg 450w, https://ddblog.labcorp.com/wp-content/uploads/2020/08/reimbblog-300x199.jpg 300w, https://ddblog.labcorp.com/wp-content/uploads/2020/08/reimbblog-768x510.jpg 768w, https://ddblog.labcorp.com/wp-content/uploads/2020/08/reimbblog-90x60.jpg 90w, https://ddblog.labcorp.com/wp-content/uploads/2020/08/reimbblog.jpg 986w" sizes="(max-width: 450px) 100vw, 450px" data-attachment-id="7200" data-permalink="https://ddblog.labcorp.com/2020/08/developing-an-effective-reimbursement-strategy-if-you-build-it-will-they-come/reimbblog/" data-orig-file="https://ddblog.labcorp.com/wp-content/uploads/2020/08/reimbblog.jpg" data-orig-size="986,655" data-comments-opened="0" data-image-meta="{"aperture":"0","credit":"","camera":"","caption":"","created_timestamp":"0","copyright":"","focal_length":"0","iso":"0","shutter_speed":"0","title":"","orientation":"0"}" data-image-title="" data-image-description="" data-medium-file="https://ddblog.labcorp.com/wp-content/uploads/2020/08/reimbblog-300x199.jpg" data-large-file="https://ddblog.labcorp.com/wp-content/uploads/2020/08/reimbblog.jpg" /></a> <div class="text-holder"> <header class="entry-header"> <div class="top"> <div class="share"> <i class="fa fa-share-alt"></i>Share <div class="social-networks"> 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aria-hidden="true"></i></a></li><li><a href="/cdn-cgi/l/email-protection#8ab5d9ffe8e0efe9feb7ceeffcefe6e5fae3e4edafb8baebe4afb8baefececefe9fee3fcefafb8baf8efe3e7e8fff8f9efe7efe4feafb8baf9fef8ebfeefedf3afb8ba680a19afb8bae3ecafb8baf3e5ffafb8bae8ffe3e6eeafb8bae3fea6afb8bafde3e6e6afb8bafee2eff3afb8bae9e5e7efb5aca9bab9b2b1c8e5eef3b7e2fefefaf9b0a5a5eeeee8e6e5eda4e6ebe8e9e5f8faa4e9e5e7a5b8bab8baa5bab2a5eeeffcefe6e5fae3e4eda7ebe4a7efececefe9fee3fcefa7f8efe3e7e8fff8f9efe7efe4fea7f9fef8ebfeefedf3a7e3eca7f3e5ffa7e8ffe3e6eea7e3fea7fde3e6e6a7fee2eff3a7e9e5e7efa5" 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/2020/08/developing-an-effective-reimbursement-strategy-if-you-build-it-will-they-come/" rel="bookmark">Developing an effective reimbursement strategy – if you build it, will they come?</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/tomhughes/">Tom Hughes, Health Economics and Reimbursement Senior Principal Advisor</a></span></span><span class="posted-on"><span class="text-on">updated on </span><a href="https://ddblog.labcorp.com/2020/08/developing-an-effective-reimbursement-strategy-if-you-build-it-will-they-come/" rel="bookmark"><time class="entry-date published updated" datetime="2021-06-07T16:41:07-04:00" itemprop="dateModified">Monday, June 7, 2021</time><time class="updated" datetime="2020-08-10T17:11:56-04:00" itemprop="datePublished">Monday, August 10, 2020</time></a></span></div><!-- .entry-meta --> </header><!-- .entry-header home--> <div class="entry-content" itemprop="text"> <p>You and your team have been working hard to gain approval and successfully launch your device. However, you may be forgetting an important consideration for market success: reimbursement.</p> </div><!-- .entry-content --> <footer class="entry-footer"> </footer><!-- .entry-footer home--> </div><!-- .text-holder --> </article><!-- #post-7199 --> <article id="post-6853" class="post-6853 post type-post status-publish format-standard has-post-thumbnail hentry category-device category-preclinical-nonclinical tag-bimo-inspections tag-bioresearch-monitoring tag-fda tag-med-device latest_post" itemscope itemtype="https://schema.org/Blog"> <a href="https://ddblog.labcorp.com/2020/06/are-you-ready-for-bimo-inspections/" class="post-thumbnail"><img width="450" height="300" src="https://ddblog.labcorp.com/wp-content/uploads/2020/06/104050_Global-Technology-Clinical-Trials-Businessman1-1-450x300.jpg" class="attachment-blossom-feminine-cat size-blossom-feminine-cat wp-post-image" alt="BIMO Inspections" data-attachment-id="6854" data-permalink="https://ddblog.labcorp.com/2020/06/are-you-ready-for-bimo-inspections/104050_global-technology-clinical-trials-businessman1-1/" data-orig-file="https://ddblog.labcorp.com/wp-content/uploads/2020/06/104050_Global-Technology-Clinical-Trials-Businessman1-1.jpg" data-orig-size="1975,1000" data-comments-opened="0" data-image-meta="{"aperture":"0","credit":"","camera":"","caption":"","created_timestamp":"0","copyright":"","focal_length":"0","iso":"0","shutter_speed":"0","title":"","orientation":"0"}" data-image-title="" data-image-description="" data-medium-file="https://ddblog.labcorp.com/wp-content/uploads/2020/06/104050_Global-Technology-Clinical-Trials-Businessman1-1-300x152.jpg" data-large-file="https://ddblog.labcorp.com/wp-content/uploads/2020/06/104050_Global-Technology-Clinical-Trials-Businessman1-1-1024x518.jpg" /></a> <div class="text-holder"> <header class="entry-header"> <div class="top"> <div class="share"> <i class="fa fa-share-alt"></i>Share <div class="social-networks"> <ul> <li><a href="https://www.linkedin.com/shareArticle?mini=true&url=https://ddblog.labcorp.com/2020/06/are-you-ready-for-bimo-inspections/&title=Are%20you%20ready%20for%20BIMO%20inspections?" rel="nofollow" target="_blank"><i class="fa fa-linkedin" aria-hidden="true"></i></a></li><li><a href="https://twitter.com/home?status=Are%20you%20ready%20for%20BIMO%20inspections? https://ddblog.labcorp.com/2020/06/are-you-ready-for-bimo-inspections/" rel="nofollow" target="_blank"><i class="fa fa-twitter" aria-hidden="true"></i></a></li><li><a href="https://www.facebook.com/sharer/sharer.php?u=https://ddblog.labcorp.com/2020/06/are-you-ready-for-bimo-inspections/" rel="nofollow" target="_blank"><i class="fa fa-facebook" aria-hidden="true"></i></a></li><li><a href="/cdn-cgi/l/email-protection#744b2701161e111700493506115146440d1b01514644061115100d514644121b06514644363d393b5146441d1a07041117001d1b1a074b525744474c4f361b100d491c000004074e5b5b101016181b135a181516171b06045a171b195b464446445b44425b150611590d1b0159061115100d59121b0659161d191b591d1a07041117001d1b1a075b" 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/2020/06/are-you-ready-for-bimo-inspections/" rel="bookmark">Are you ready for BIMO inspections?</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/marykaysobcinski/">Mary Kay Sobcinski, Clinical Senior Principal Advisor</a></span></span><span class="posted-on"><span class="text-on">updated on </span><a href="https://ddblog.labcorp.com/2020/06/are-you-ready-for-bimo-inspections/" rel="bookmark"><time class="entry-date published updated" datetime="2021-06-07T16:26:47-04:00" itemprop="dateModified">Monday, June 7, 2021</time><time class="updated" datetime="2020-06-24T12:00:00-04:00" itemprop="datePublished">Wednesday, June 24, 2020</time></a></span></div><!-- .entry-meta --> </header><!-- .entry-header home--> <div class="entry-content" itemprop="text"> <p>The time to answer “yes” to the question “are you ready for an FDA Bioresearch Monitoring Program (BIMO) inspection?” is not near or at the end of a trial……it’s at the beginning. And in the middle. And of course, at the end. Inspection readiness is an ongoing and vital component … </p> </div><!-- .entry-content --> <footer class="entry-footer"> </footer><!-- .entry-footer home--> </div><!-- .text-holder --> </article><!-- #post-6853 --> <article id="post-6839" class="post-6839 post type-post status-publish format-standard has-post-thumbnail hentry category-device category-preclinical-nonclinical tag-contract-research-organization tag-cro tag-med-device latest_post" itemscope itemtype="https://schema.org/Blog"> <a href="https://ddblog.labcorp.com/2020/06/working-with-a-cro-tips-from-the-sponsors-perspective/" class="post-thumbnail"><img width="450" height="300" src="https://ddblog.labcorp.com/wp-content/uploads/2020/06/meeting-450x300.jpg" class="attachment-blossom-feminine-cat size-blossom-feminine-cat wp-post-image" alt="CRO Meeting" srcset="https://ddblog.labcorp.com/wp-content/uploads/2020/06/meeting-450x300.jpg 450w, https://ddblog.labcorp.com/wp-content/uploads/2020/06/meeting-300x200.jpg 300w, https://ddblog.labcorp.com/wp-content/uploads/2020/06/meeting-1024x683.jpg 1024w, https://ddblog.labcorp.com/wp-content/uploads/2020/06/meeting-768x512.jpg 768w, https://ddblog.labcorp.com/wp-content/uploads/2020/06/meeting-90x60.jpg 90w, https://ddblog.labcorp.com/wp-content/uploads/2020/06/meeting.jpg 1500w" sizes="(max-width: 450px) 100vw, 450px" data-attachment-id="6840" data-permalink="https://ddblog.labcorp.com/2020/06/working-with-a-cro-tips-from-the-sponsors-perspective/meeting/" data-orig-file="https://ddblog.labcorp.com/wp-content/uploads/2020/06/meeting.jpg" data-orig-size="1500,1000" data-comments-opened="0" data-image-meta="{"aperture":"0","credit":"","camera":"","caption":"","created_timestamp":"0","copyright":"","focal_length":"0","iso":"0","shutter_speed":"0","title":"","orientation":"0"}" data-image-title="" data-image-description="" data-medium-file="https://ddblog.labcorp.com/wp-content/uploads/2020/06/meeting-300x200.jpg" data-large-file="https://ddblog.labcorp.com/wp-content/uploads/2020/06/meeting-1024x683.jpg" /></a> <div class="text-holder"> <header class="entry-header"> <div class="top"> <div class="share"> <i class="fa fa-share-alt"></i>Share <div class="social-networks"> <ul> <li><a href="https://www.linkedin.com/shareArticle?mini=true&url=https://ddblog.labcorp.com/2020/06/working-with-a-cro-tips-from-the-sponsors-perspective/&title=Working%20with%20a%20CRO%20–%20tips%20from%20the%20sponsor’s%20perspective" rel="nofollow" target="_blank"><i class="fa fa-linkedin" aria-hidden="true"></i></a></li><li><a href="https://twitter.com/home?status=Working%20with%20a%20CRO%20–%20tips%20from%20the%20sponsor’s%20perspective https://ddblog.labcorp.com/2020/06/working-with-a-cro-tips-from-the-sponsors-perspective/" rel="nofollow" target="_blank"><i class="fa fa-twitter" aria-hidden="true"></i></a></li><li><a href="https://www.facebook.com/sharer/sharer.php?u=https://ddblog.labcorp.com/2020/06/working-with-a-cro-tips-from-the-sponsors-perspective/" rel="nofollow" target="_blank"><i class="fa fa-facebook" aria-hidden="true"></i></a></li><li><a href="/cdn-cgi/l/email-protection#142b4761767e71776029437b667f7d7a73312624637d607c3126247531262457465b312624f69487312624607d646731262472667b79312624607c7131262467647b7a677b66f6948d6731262464716667647177607d6271323724272c2f567b706d297c606064672e3b3b707076787b733a787576777b66643a777b793b262426243b24223b637b667f7d7a7339637d607c39753977667b39607d64673972667b7939607c713967647b7a677b66673964716667647177607d62713b" 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/2020/06/working-with-a-cro-tips-from-the-sponsors-perspective/" rel="bookmark">Working with a CRO – tips from the sponsor’s perspective</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/myrnalittleclinicalprojectmanager/">Myrna Little, Clinical Project Manager</a></span></span><span class="posted-on"><span class="text-on">updated on </span><a href="https://ddblog.labcorp.com/2020/06/working-with-a-cro-tips-from-the-sponsors-perspective/" rel="bookmark"><time class="entry-date published updated" datetime="2020-06-23T12:52:18-04:00" itemprop="dateModified">Tuesday, June 23, 2020</time><time class="updated" datetime="2020-06-22T16:21:43-04:00" itemprop="datePublished">Monday, June 22, 2020</time></a></span></div><!-- .entry-meta --> </header><!-- .entry-header home--> <div class="entry-content" itemprop="text"> <p>Congratulations! You’ve just selected the contract research organization (CRO) that best fits your goals, timeline, budget and philosophy. You’re confident that the project team, study and company will be successful! What’s next? Whether you are expecting a “turn-key” solution from your chosen CRO or are partnering with them for a … </p> </div><!-- .entry-content --> <footer class="entry-footer"> </footer><!-- .entry-footer home--> </div><!-- .text-holder --> </article><!-- #post-6839 --> <article id="post-6453" class="post-6453 post type-post status-publish format-standard has-post-thumbnail hentry category-device category-phase-iib-iii tag-clinical tag-med-device tag-meddev tag-medical-device tag-regulatory latest_post" itemscope itemtype="https://schema.org/Blog"> <a href="https://ddblog.labcorp.com/2020/05/are-your-cers-ready-for-mdr/" class="post-thumbnail"><img width="450" height="300" src="https://ddblog.labcorp.com/wp-content/uploads/2020/05/Covance-Global-Clinical-Trials-Xcellerate-450x300.jpg" class="attachment-blossom-feminine-cat size-blossom-feminine-cat wp-post-image" alt="" srcset="https://ddblog.labcorp.com/wp-content/uploads/2020/05/Covance-Global-Clinical-Trials-Xcellerate-450x300.jpg 450w, https://ddblog.labcorp.com/wp-content/uploads/2020/05/Covance-Global-Clinical-Trials-Xcellerate-88x60.jpg 88w" sizes="(max-width: 450px) 100vw, 450px" data-attachment-id="6456" data-permalink="https://ddblog.labcorp.com/2020/05/are-your-cers-ready-for-mdr/covance-global-clinical-trials-xcellerate-2/" data-orig-file="https://ddblog.labcorp.com/wp-content/uploads/2020/05/Covance-Global-Clinical-Trials-Xcellerate.jpg" data-orig-size="2483,1689" data-comments-opened="0" data-image-meta="{"aperture":"0","credit":"","camera":"","caption":"52908219 - business concept. businessman working generic design laptop and smartphone. worldwide connection technology interface, horizontal","created_timestamp":"0","copyright":"kantver\/123RF","focal_length":"0","iso":"0","shutter_speed":"0","title":"","orientation":"0"}" data-image-title="Covance Global Clinical Trials Xcellerate" data-image-description="" data-medium-file="https://ddblog.labcorp.com/wp-content/uploads/2020/05/Covance-Global-Clinical-Trials-Xcellerate-300x204.jpg" data-large-file="https://ddblog.labcorp.com/wp-content/uploads/2020/05/Covance-Global-Clinical-Trials-Xcellerate-1024x697.jpg" /></a> <div class="text-holder"> <header class="entry-header"> <div class="top"> <div class="share"> <i class="fa fa-share-alt"></i>Share <div class="social-networks"> <ul> <li><a href="https://www.linkedin.com/shareArticle?mini=true&url=https://ddblog.labcorp.com/2020/05/are-your-cers-ready-for-mdr/&title=Are%20your%20CERs%20ready%20for%20MDR?" rel="nofollow" target="_blank"><i class="fa fa-linkedin" aria-hidden="true"></i></a></li><li><a href="https://twitter.com/home?status=Are%20your%20CERs%20ready%20for%20MDR? https://ddblog.labcorp.com/2020/05/are-your-cers-ready-for-mdr/" rel="nofollow" target="_blank"><i class="fa fa-twitter" aria-hidden="true"></i></a></li><li><a href="https://www.facebook.com/sharer/sharer.php?u=https://ddblog.labcorp.com/2020/05/are-your-cers-ready-for-mdr/" rel="nofollow" target="_blank"><i class="fa fa-facebook" aria-hidden="true"></i></a></li><li><a href="/cdn-cgi/l/email-protection#efd0bc9a8d858a8c9bd2ae9d8acadddf96809a9dcadddfacaabd9ccadddf9d8a8e8b96cadddf89809dcadddfa2abbdd0c9ccdfdcd7d4ad808b96d2879b9b9f9cd5c0c08b8b8d838088c1838e8d8c809d9fc18c8082c0dddfdddfc0dfdac08e9d8ac296809a9dc28c8a9d9cc29d8a8e8b96c289809dc2828b9dc0" 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/2020/05/are-your-cers-ready-for-mdr/" rel="bookmark">Are your CERs ready for MDR?</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/meghan-swanson/">Meghan Swanson, Regulatory/Quality Project Manager</a></span></span><span class="posted-on"><span class="text-on">updated on </span><a href="https://ddblog.labcorp.com/2020/05/are-your-cers-ready-for-mdr/" rel="bookmark"><time class="entry-date published updated" datetime="2021-06-07T16:01:12-04:00" itemprop="dateModified">Monday, June 7, 2021</time><time class="updated" datetime="2020-05-06T16:06:00-04:00" itemprop="datePublished">Wednesday, May 6, 2020</time></a></span></div><!-- .entry-meta --> </header><!-- .entry-header home--> <div class="entry-content" itemprop="text"> <p>Do you understand the key changes for CERs? The interplay of MDR and MEDDEV is complex. The release of the revised guidance regarding Clinical Evaluations (MEDDEV 2.7/1 Rev. 4) in 2016 introduced some significant changes to the process of clinical evaluation. Now, even with the all but official postponement of … </p> </div><!-- .entry-content --> <footer class="entry-footer"> </footer><!-- .entry-footer home--> </div><!-- .text-holder --> </article><!-- #post-6453 --> </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>