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Support</a></li> </ul> </div> </div> </div> </div> </div> </div> </div> </div> <nav class="breadcrumb p-y border-bottom"> <div class="container"><svg class="icon icon-home2"><use xlink:href="#icon-home2"></use></svg><span><span><a href="https://gi.org/">Gi.org</a></span> / <span><a href="https://gi.org/practice-management/">Practice Management</a></span> / <span class="breadcrumb_last" aria-current="page">FDA Information</span></span></div> </nav> <header class="bg-triangles-primary text-inverse"> <div class="container p-y-md"> <h1 class="main-title"> FDA Information </h1> </div> </header> <main id="main" class=" container p-y-lg main-content"> <article id="post-20761" class="post-20761 page type-page status-publish hentry"> <section class="row-container "> <div class=""> <div class="row col-count-2"> <div class="col col-md-3 col-xs-12 last-md"> <div id="sidebar" class="border-t border-4 border-primary"> <ul class="list-items"> <li><a href="#section1">Recent ACG FDA Committee Actions</a></li> <li><a href="#section2">Important Resources From the FDA</a></li> </ul> </div> </div> <div class="col col-md-9 col-xs-12 first-md"> <h2 class="text-normal text-600 p-a bg-secondary text-inverse" id="section1">Recent ACG FDA Committee Actions</h2> <ul> <li><span style="color:#b71c1c;"><i><strong>New! </strong></i></span>AJG Red Section Article: <a target="_blank" rel="noopener noreferrer" href="https://journals.lww.com/ajg/fulltext/2024/02000/overview_of_biosimilars_in_inflammatory_bowel.2.aspx">Overview of Biosimilars in Inflammatory Bowel Diseases</a></li> <li>Clinical & Translational Gastroenterology Editorial: <a target="_blank" rel="noopener noreferrer" href="https://journals.lww.com/ctg/fulltext/2023/11000/microbiome_based_therapeutics_in_digestive.1.aspx">Microbiome-Based Therapeutics in Digestive Diseases: What They Are and How Are They Regulated</a></li> <li>ACG Magazine Spring ’23 Article: <a target="_blank" rel="noopener noreferrer" href="https://issuu.com/amcollegegastro/docs/23acgmag-spring-fin/16">Getting it Right: How FDA Drug and Biologic Therapy Labels Are Developed and How to Optimize Their Use in Clinical Practice</a></li> <li><a href="https://webfiles.gi.org/docs/pm/ACG-Guidance_FDA-Advisory-Committees-Its%20Role-and-How-To-Contribute.pdf" target="_blank">FDA Advisory Committees: Its Role and How To Contribute</a></li> <li><a class="toggle-item toggle-target-next toggle-is-toggled" href="#">Accessing Food and Drug Administration resources in clinical practice: A primer for the practicing gastroenterologist</a> <div class="toggled-item"> <p>The inner workings of the Food and Drug Administration (FDA) can seem elusive from the realities of the day-to-day clinical practice. For the FDA to accomplish its mission, they have exclusive access to comprehensive and historical clinical trial data and a wealth of outcomes data. These data include the largest claims dataset covering over 227 million Americans, including patient-level data (2). Staying up-to-date with FDA communications is important as gastroenterologists and their patients look for guidance in areas of rapid innovation such as biosimilars(3), fecal microbiota for transplantation(4), and endoscopic bariatric treatments.</p> <p><a href="https://gi.org/practice-management/fda-information/accessing-food-and-drug-administration-resources-in-clinical-practice-a-primer-for-the-practicing-gastroenterologist/">Click here</a> for a summary of useful datasets and resources published on the FDA website which can enable gastroenterologists to stay current with regulatory guidance and access valuable FDA resources.</p><br /> </div> </li> </ul> <h2 class="text-normal text-600 p-a bg-primary text-inverse m-t-lg" id="section2">Important Resources From the FDA</h2> <ul> <li><a href="http://www.fda.gov/" target="_blank">FDA</a></li> <li><a href="http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/" target="_blank">FDA Approved Drug Products</a></li> <li><a href="http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm" target="_blank">Guidances (Drugs)</a></li> <li><a href="https://www.fda.gov/Safety/MedWatch/default.htm" target="_blank">FDA MedWatch: Report an Adverse Event to FDA (form FDA 3500)</a></li> <li><a href="http://www.fda.gov/safety/recalls/default.htm" target="_blank">Recalls, Market Withdrawals & Safety Alerts</a></li> <li><a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/index-drug-specific-information" target="_blank">Index to Specific Drug Information</a></li> <li><a href="https://www.fda.gov/vaccines-blood-biologics/fecal-microbiota-products" target="_blank">Fecal Microbiota Products and FMT</a></li> <li>Accessing Domperidone:</li> <ul> <li><a href="https://www.fda.gov/drugs/information-drug-class/information-about-domperidone" target="_blank">Information about Domperidone</a></li> <li><a href="https://www.fda.gov/drugs/investigational-new-drug-ind-application/how-request-domperidone-expanded-access-use" target="_blank">How to Request Domperidone for Expanded Access Use</a></li> </ul> </ul> </div> </div> </div> </section>   </article> </main> <div class="footer-container m-t-lg"> <div class="position-relative border-bottom hidden-print" id="footer-promo"> <div class="bg-primary-lightest border-b border-1 border-primary bg-triangles"> <div class="container p-y-md text-center"> <span class="logo-footer"><img src="https://acgcdn.gi.org/themes/giorg/img/logo.svg" class="img-circle" width="50"></span> <div class="display-2 text-300">Advancing Digestive Health, Improving Patient Outcomes</div> </div> </div> </div> <div class="bg-white text-sm hidden-print" id="footer"> <div class="container"> <div class="p-y-md site-footer"> <div class="row"> <div class="col-sm-3 col-xs-6"> <div class="textwidget"><h3><a class="text-hover-underline" 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