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class="tabs"></div> <div class="region region-content"> <div id="block-system-main" class="block block-system"> <div class="content"> <div id="node-1551" class="node node-page slider-secondary clearfix" about="/ind-development-process" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="The IND Development Process" class="rdf-meta element-hidden"></span><span property="sioc:num_replies" content="0" datatype="xsd:integer" class="rdf-meta element-hidden"></span> <div class="content"> <div class="field field-name-field-last-revised field-type-datetime field-label-inline inline"><div class="field-label">Last revised<span class="colon">:</span> </div><div class="field-items"><div class="field-item even"><span property="dc:date" datatype="xsd:dateTime" content="2015-08-13T00:00:00-07:00" class="date-display-single">08/13/2015</span></div></div></div><div class="field field-name-field-body field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even"><p>Confused about the need to file an IND? Think your study may be exempt? Not sure where to start? You are not alone. The <em>HUB</em> provides information, templates and resources to guide you through the IND process.</p> <p>An academic researcher may be required to submit an IND application to the FDA in order to study a marketed medical product in a new (i.e. unapproved) clinical indication. An investigator is always required to hold an IND to study an unmarketed (i.e. unapproved) medical product. In both cases, the products are considered "investigational" by FDA. The vast majority of INDs on file with the FDA are for noncommercial research.</p> <p>This toolkit (adapted from The Institute of Translational Health Sciences) helps you navigate each step of the IND process by providing guidance and templates relevant to each step. The information provided focuses on INDs for studies of marketed medical products for new indications.</p> <p>For additional information on submitting INDs for unmarketed medical products and/or review of your IND submission, please contact <a href="http://ctsi.ucsf.edu/consult">CTSI Consultation Services</a>. Please review the latest <a href="/sites/g/files/tkssra261/f/wysiwyg/Determining%20whether%20IND%20needed_Sept%202013with2015stayedsections.pdf">FDA guidance for determining the need for an IND</a>.</p> <p>Need assistance or have regulatory questions? Please contact <a href="http://ctsi.ucsf.edu/consult">CTSI Consultation Services</a></p> </div></div></div> </div> </div> </div> </div> </div> </div> </div> <div id="sidebar" class="column"> <div class="sidebar"> <div class="section"> <div class="region region-sidebar"> <div id="block-menu-block-3" class="block block-menu-block"> <h3><a href="/ind-development-process" class="active-trail active">IND Development Process</a></h3> <div class="content"> <div class="menu-block-wrapper menu-block-3 menu-name-main-menu parent-mlid-0 menu-level-3"> <ul class="menu"><li class="first leaf menu-mlid-2251"><a href="/pre-ind-process">The Pre-IND Process</a></li> <li class="leaf menu-mlid-2421"><a href="/ind-study-protocol">The IND Study Protocol</a></li> <li class="leaf menu-mlid-2291"><a href="/prepare-ind-submission">Prepare the Initial IND Submission</a></li> <li class="leaf menu-mlid-2366"><a href="/file-ind">File the Initial IND</a></li> <li class="leaf menu-mlid-2206"><a href="/maintain-ind">Maintain the IND</a></li> <li class="last leaf menu-mlid-2436"><a href="/ind-resources">IND Templates, Education & Useful Links</a></li> </ul></div> </div> </div> </div> </div> </div> </div> </div></div> <div id="footer"> <div class="section"> <div class="region region-footer"> <div id="block-block-6" class="block block-block"> <div class="content"> <style type="text/css"> <![CDATA[/* ><!]]>*/ </style> <div class="quickref"> <h2 style="color:#000;font-size:22px;margin:0;padding: 0 0 6px;">Quick Reference</h2> <div class="wysiwyg_threecols layout--33-33-33"> <div class="wysiwyg_threecols--first"> <ul> <li><a href="http://policies.ucsf.edu/" target="_blank">Campus Policies</a></li> <li><a href="http://cancer.ucsf.edu/" target="_blank">Cancer Center (HDFCCC)</a></li> <li><a href="http://accelerate.ucsf.edu/research/crs" target="_blank">Clinical Research Services</a></li> <li><a href="http://ctsi.ucsf.edu" target="_blank">Clinical & Translational Science Institute (CTSI)</a></li> </ul> </div> <div class="wysiwyg_threecols--second"> <ul> <li><a href="http://coi.ucsf.edu/" target="_blank">Conflicts of Interest (COI)</a></li> <li><a href="http://accelerate.ucsf.edu/consult" target="_blank">Consultation Services</a></li> <li><a href="http://accelerate.ucsf.edu/cores/" target="_blank">Cores Search</a></li> <li><a href="https://ehs.ucsf.edu/" target="_blank">Environment, Health and Safety</a></li> <li><a href="http://compliance.ucsf.edu/" target="_blank">Ethics & Compliance</a></li> </ul> </div> <div class="wysiwyg_threecols--third"> <ul> <li><a href="http://globalhealthsciences.ucsf.edu/" target="_blank">Global Health Sciences</a></li> <li><a href="http://ita.ucsf.edu/" target="_blank">Innovation, Technology & Alliances</a></li> <li><a href="http://irb.ucsf.edu" target="_blank">IRB / Human Research Protection Program</a></li> <li><a href="https://osr.ucsf.edu/" target="_blank">Office of Sponsored Research</a></li> <li><a href="http://profiles.ucsf.edu" target="_blank">UCSF Profiles</a></li> </ul> </div> </div> </div> <p style="float: right; margin: 1.2em 30px -1.5em; text-align: right; width: 6em;"><a href="/cdn-cgi/l/email-protection#9ad2cfd8daeff9e9fcb4fffeef" style="color:#FFF"><span class="__cf_email__" data-cfemail="652d302725100616034b000110">[email protected]</span></a></p> </div> </div> </div> <div class="footer-bottom"> <nav aria-label="Footer Navigation" class="footer--navigation"> <ul> <li><a href="/cdn-cgi/l/email-protection#226a776062574151440c474657">Contact Us</a></li> <li><a href="https://www.ucsf.edu/accessibility-resources">Accessibility</a></li> <li><a href="https://www.ucsf.edu/website-privacy-policy">Privacy Policy</a></li> <li><a href="https://websites.ucsf.edu/website-terms-use">Terms of Use </a></li> <li><a href="https://websites.ucsf.edu/azlist">A-Z Website List</a></li> </ul> </nav> <div class="footer--copyright"> <p>© 2024 The Regents of the University of California</p> </div> </div> </div> </div> </div> </div> <script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script><script type="text/javascript"> /*<![CDATA[*/ (function() { var sz = document.createElement('script'); sz.type = 'text/javascript'; sz.async = true; sz.src = '//siteimproveanalytics.com/js/siteanalyze_8343.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(sz, s); })(); /*]]>*/ </script> </body> </html>