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href="https://blog.covance.com/2020/07/in-vitro-drug-drug-interaction-ddi-regulation-updates-in-the-fdas-2020-guidance-a-summary/" rel="bookmark">In vitro drug-drug interaction (DDI) regulation updates in the FDA’s 2020 guidance: A summary</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://blog.covance.com/author/covance/">Covance by Labcorp</a></span></span><span class="posted-on"><span class="text-on">updated on </span><a href="https://blog.covance.com/2020/07/in-vitro-drug-drug-interaction-ddi-regulation-updates-in-the-fdas-2020-guidance-a-summary/" rel="bookmark"><time class="entry-date published updated" datetime="2020-08-04T11:11:59-04:00" itemprop="dateModified">Tuesday, August 4, 2020</time><time class="updated" datetime="2020-07-19T03:49:00-04:00" itemprop="datePublished">Sunday, July 19, 2020</time></a></span></div><!-- .entry-meta --> </header><!-- .entry-header home--> <div class="entry-content" itemprop="text"> <p>In January 2020 the Food and Drug Administration (FDA) reviewed its 2017 draft content and published finalized guidance for in vitro and clinical drug interaction studies. We’ve summarized the the key changes and implications for in vitro drug-drug interactions (DDI) testing in this post, but if you would like more … </p> </div><!-- .entry-content --> <footer class="entry-footer"> </footer><!-- .entry-footer home--> </div><!-- .text-holder --> </article><!-- #post-6921 --> <article id="post-6545" class="post-6545 post type-post status-publish format-standard has-post-thumbnail hentry category-metabolism-pk category-preclinical-nonclinical category-regulatory-agencies tag-ema tag-fda tag-pmda latest_post" itemscope itemtype="https://schema.org/Blog"> <a href="https://blog.covance.com/2020/06/a-comparison-of-fda-ema-pmda-regulatory-agency-guidance-for-in-vitro-drug-drug-interaction-ddi-assessments/" class="post-thumbnail"><img width="450" height="300" src="https://blog.covance.com/wp-content/uploads/2020/06/FDA-EMA-PMDA-Regulatory-Agencies-450x300.jpg" class="attachment-blossom-feminine-cat size-blossom-feminine-cat wp-post-image" alt="" data-attachment-id="6773" data-permalink="https://blog.covance.com/2020/06/a-comparison-of-fda-ema-pmda-regulatory-agency-guidance-for-in-vitro-drug-drug-interaction-ddi-assessments/fda-ema-pmda-regulatory-agencies/" data-orig-file="https://blog.covance.com/wp-content/uploads/2020/06/FDA-EMA-PMDA-Regulatory-Agencies.jpg" data-orig-size="1200,627" 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="FDA-EMA-PMDA-Regulatory-Agencies" data-image-description="" data-medium-file="https://blog.covance.com/wp-content/uploads/2020/06/FDA-EMA-PMDA-Regulatory-Agencies-300x157.jpg" data-large-file="https://blog.covance.com/wp-content/uploads/2020/06/FDA-EMA-PMDA-Regulatory-Agencies-1024x535.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://blog.covance.com/2020/06/a-comparison-of-fda-ema-pmda-regulatory-agency-guidance-for-in-vitro-drug-drug-interaction-ddi-assessments/&title=A%20comparison%20of%20FDA,%20EMA%20&%20PMDA%20regulatory%20guidance%20for%20in%20vitro%20drug-drug%20interaction%20(DDI)%20assessments" rel="nofollow" target="_blank"><i class="fa fa-linkedin" aria-hidden="true"></i></a></li><li><a href="https://twitter.com/home?status=A%20comparison%20of%20FDA,%20EMA%20&%20PMDA%20regulatory%20guidance%20for%20in%20vitro%20drug-drug%20interaction%20(DDI)%20assessments https://blog.covance.com/2020/06/a-comparison-of-fda-ema-pmda-regulatory-agency-guidance-for-in-vitro-drug-drug-interaction-ddi-assessments/" 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://blog.covance.com/2020/06/a-comparison-of-fda-ema-pmda-regulatory-agency-guidance-for-in-vitro-drug-drug-interaction-ddi-assessments/" rel="nofollow" target="_blank"><i class="fa fa-facebook" aria-hidden="true"></i></a></li><li><a href="mailto:?Subject=A%20comparison%20of%20FDA,%20EMA%20&%20PMDA%20regulatory%20guidance%20for%20in%20vitro%20drug-drug%20interaction%20(DDI)%20assessments&Body=https://blog.covance.com/2020/06/a-comparison-of-fda-ema-pmda-regulatory-agency-guidance-for-in-vitro-drug-drug-interaction-ddi-assessments/" 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://blog.covance.com/2020/06/a-comparison-of-fda-ema-pmda-regulatory-agency-guidance-for-in-vitro-drug-drug-interaction-ddi-assessments/" rel="bookmark">A comparison of FDA, EMA & PMDA regulatory guidance for in vitro drug-drug interaction (DDI) assessments</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://blog.covance.com/author/covance/">Covance by Labcorp</a></span></span><span class="posted-on"><span class="text-on">updated on </span><a href="https://blog.covance.com/2020/06/a-comparison-of-fda-ema-pmda-regulatory-agency-guidance-for-in-vitro-drug-drug-interaction-ddi-assessments/" rel="bookmark"><time class="entry-date published updated" datetime="2020-08-26T11:46:53-04:00" itemprop="dateModified">Wednesday, August 26, 2020</time><time class="updated" datetime="2020-06-29T08:27:53-04:00" itemprop="datePublished">Monday, June 29, 2020</time></a></span></div><!-- .entry-meta --> </header><!-- .entry-header home--> <div class="entry-content" itemprop="text"> <p>This online whitepaper article explores the 2020 regulatory changes in U.S. FDA guidance1 and recommendations, compared to existing EU EMA2 and Japanese PMDA3 guidance for in in vitro drug–drug interaction (DDI) assessments.</p> </div><!-- .entry-content --> <footer class="entry-footer"> </footer><!-- .entry-footer home--> </div><!-- .text-holder --> </article><!-- #post-6545 --> </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 © 2020 Covance Inc. 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