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class="taxonomy-header__image-container"><section class="taxonomy-menu"><div class="taxonomy-menu__title-wrapper"><span class="taxonomy-menu__hamburger" id="taxonomy-menu-hamburger"></span><h1 class="taxonomy-menu__title">Regulatory</h1></div></section></div><section id="taxonomy-header-tabs" class="taxonomy-header-tabs "> <ul class="taxonomy-header-tabs__items"> <li class="taxonomy-header-tabs__item"> <a class="taxonomy-header-tabs__item-title taxonomy-header-tabs__item-title--active" href="#">Regulatory</a><div class="taxonomy-header-tabs__item-content taxonomy-header-tabs__item-content--open"><ul class="taxonomy-header-tabs__topic-subgroup"><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/404-505-b-2">505(b)(2)</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/405-510-k">510(k)</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/406-accelerated-review">Accelerated review</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/409-anvisa">ANVISA</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/410-barda">BARDA</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/413-bla">BLA</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/414-breakthrough-therapy">Breakthrough therapy</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/415-bsufa">BsUFA</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/416-cdrh">CDRH</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/418-central-drugs-standard-control-organization">Central Drugs Standard Control Organization</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/419-centre-for-pharmaceutical-administration-health-sciences-authority">Centre for Pharmaceutical Administration Health Sciences Authority</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/420-chmp">CHMP</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/421-class-i">Class I</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/422-class-ii">Class II</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/423-class-iii">Class III</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/424-cms">CMS</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/426-courts">Courts</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/428-danish-medicines-agency">Danish Medicines Agency</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/429-de-novo">De novo</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/430-ema">EMA</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/432-fast-track">Fast track</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/433-fda">FDA</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/435-ftc">FTC</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/436-gdufa">GDUFA</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/438-gmp">GMP</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/439-health-canada">Health Canada</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/440-ich">ICH</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/441-ide">IDE</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/442-ind">IND</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/446-irish-medicines-board">Irish Medicines Board</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/447-italian-pharmaceutical-agency">Italian Pharmaceutical Agency</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/448-legislation">Legislation</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/449-mdufa">MDUFA</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/450-medical-countermeasures">Medical Countermeasures</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/452-medical-products-agency">Medical Products Agency</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/453-medicare">Medicare</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/455-medicines-control-council">Medicines Control Council</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/456-medicines-evaluation-board">Medicines Evaluation Board</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/457-medsafe-medicines-and-medical-devices-safety-authority">Medsafe - Medicines and Medical Devices Safety Authority</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/458-mhra">MHRA</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/459-ministry-of-health">Ministry of Health</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/460-mhlw">MHLW</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/567-mohw">MOHW</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/464-nda">NDA</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/467-nice">NICE</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/468-nih">NIH</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/469-nme">NME</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/556-nmpa">NMPA</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/470-orange-book">Orange book</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/471-orphan-drug">Orphan drug</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/472-patents">Patents</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/473-pdufa">PDUFA</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/475-phase-i">Phase I</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/476-phase-ii">Phase II</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/477-phase-iii">Phase III</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/478-phase-iv">Phase IV</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/479-pma">PMA</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/480-pmda">PMDA</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/575-policy">Policy</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/483-priority-review">Priority review</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/484-product-recall">Product recall</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/485-qualified-infectious-disease-product">Qualified infectious disease product</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/486-sec">SEC</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/488-tga">TGA</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/490-trade">Trade</a></li><li class="taxonomy-header-tabs__topic-item"><a class="taxonomy-header-tabs__topic-item-link" href="/topics/491-who">WHO</a></li></ul></div> </li> </ul> </section></section><div id="breadcrumbs" class="breadcrumbs"><a class="" href="/">Home</a> » <a class="" href="/topics">Topics</a> » Regulatory</div><section class="article-list-hz-l3 topic-featured-articles"> <ul class="article-list-hz-l3__items"> <li class="article-list-hz-l3__item"> <article class="article-list-hz-l3__article"><figure class="article-list-hz-l3__image "><a class="thumbnail-link" href="https://www.bioworld.com/articles/718252-oz-promises-ai-innovation-lower-drug-prices-if-confirmed-to-lead-cms"><img class="article-list-hz-l3__image-thumb" loading="lazy" src="https://www.bioworld.com/ext/resources/BW-source/2025/Oz-hearing-3-14.jpg?height=355&t=1741986486&width=640" alt="Oz hearing 3 14" /></a></figure><div class="article-list-hz-l3__details -has-image"><div class="article-list-hz-l3__meta"><div class="article-list-hz-l3__post-date">March 14, 2025</div><div class="article-list-hz-l3__author"><a class="article-list-hz-l3__author-link" href="/authors/43-karen-carey"><span class="article-list-hz-l3__author-title-prefix">By </span><span class="article-list-hz-l3__author-name">Karen Carey</span></a></div></div><h1 class="article-list-hz-l3__headline"><a class="article-list-hz-l3__article-title-link" href="https://www.bioworld.com/articles/718252-oz-promises-ai-innovation-lower-drug-prices-if-confirmed-to-lead-cms">Oz promises AI, innovation, lower drug prices if confirmed to lead CMS</a></h1><div class="article-list-hz-l3__teaser">Cardiothoracic surgeon and television personality Mehmet Oz, President Donald Trump鈥檚 nominee for administrator of the Centers for Medicare & Medicaid Services (CMS), faced the U.S. Senate鈥檚 finance committee on March 14, suggesting the implementation of artificial intelligence (AI) technologies and the reduction of drug prices would be among his top priorities, if confirmed.</div></div></article> </li> <li class="article-list-hz-l3__item"> <article class="article-list-hz-l3__article"><figure class="article-list-hz-l3__image "><a class="thumbnail-link" href="https://www.bioworld.com/articles/718250-healios-posts-more-upbeat-data-on-multistem-cell-therapy-for-ards"><img class="article-list-hz-l3__image-thumb" loading="lazy" src="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Infectious/covid-19---coronavirus---lungs.png?height=355&t=1589309478&width=640" alt="Covid 19 coronavirus lungs" /></a></figure><div class="article-list-hz-l3__details -has-image"><div class="article-list-hz-l3__meta"><div class="article-list-hz-l3__post-date">March 14, 2025</div><div class="article-list-hz-l3__author"><a class="article-list-hz-l3__author-link" href="/authors/603-marian-yoonjee-chu"><span class="article-list-hz-l3__author-title-prefix">By </span><span class="article-list-hz-l3__author-name">Marian (YoonJee) Chu</span></a></div></div><h1 class="article-list-hz-l3__headline"><a class="article-list-hz-l3__article-title-link" href="https://www.bioworld.com/articles/718250-healios-posts-more-upbeat-data-on-multistem-cell-therapy-for-ards">Healios posts more upbeat data on Multistem cell therapy for ARDS</a></h1><div class="article-list-hz-l3__teaser">Latest findings on Healios K.K.鈥檚 stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.</div></div></article> </li> <li class="article-list-hz-l3__item"> <article class="article-list-hz-l3__article"><figure class="article-list-hz-l3__image "><a class="thumbnail-link" href="https://www.bioworld.com/articles/717922-team-nb-proposes-conditional-ce-marks-for-mdr-ivdr"><img class="article-list-hz-l3__image-thumb" loading="lazy" src="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/EU-Medical-Device-Regulation-MDR.png?height=355&t=1622066814&width=640" alt="Eu medical device regulation mdr" /></a></figure><div class="article-list-hz-l3__details -has-image"><div class="article-list-hz-l3__meta"><div class="article-list-hz-l3__post-date">March 14, 2025</div><div class="article-list-hz-l3__author"><a class="article-list-hz-l3__author-link" href="/authors/21-mark-mccarty"><span class="article-list-hz-l3__author-title-prefix">By </span><span class="article-list-hz-l3__author-name">Mark McCarty</span></a></div></div><h1 class="article-list-hz-l3__headline"><a class="article-list-hz-l3__article-title-link" href="https://www.bioworld.com/articles/717922-team-nb-proposes-conditional-ce-marks-for-mdr-ivdr">Team NB proposes conditional CE marks for MDR, IVDR</a></h1><div class="article-list-hz-l3__teaser">The European Association of Medical Device Notified Bodies, also known as Team NB, has proposed the issuance of a conditional CE certificate for medical devices and in vitro diagnostics, a concept said to have existed in the legacy regulations as well. The question for industry is whether this mechanism can be used to aid in the backlog of devices under the Medical Device Regulation (MDR), a problem that is still front and center in the EU eight years after passage of the index legislation.</div></div></article> </li> </ul><a class="article-list-hz-l3__more-link" href="/articles/topic/402">Read More</a> </section><section class="article-list-hz-l2 topic-articles"> <h1 class="article-list-hz-l2__title"><a class="article-list-hz-l2__title-link" href="/blogs">Blog Posts</a></h1><ul class="article-list-hz-l2__items"> <li class="article-list-hz-l2__item"> <article class="article-list-hz-l2__article"><div class="article-list-hz-l2__details"><div class="article-list-hz-l2__meta"><div class="article-list-hz-l2__post-date">Aug. 11, 2016</div><div class="article-list-hz-l2__author"><a class="article-list-hz-l2__author-link" href="/authors/4-mari-serebrov"><span class="article-list-hz-l2__author-title-prefix">By </span><span 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