For Industry

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<li><a href="/industry/fda-basics-industry" class="lcds-section-nav__section-link lcds-section-nav__link">FDA Basics for Industry</a></li> <li><a href="/industry/fda-data-standards-advisory-board" class="lcds-section-nav__section-link lcds-section-nav__link">FDA Data Standards Advisory Board</a></li> <li><a href="/industry/fda-esubmitter" class="lcds-section-nav__section-link lcds-section-nav__link">FDA eSubmitter</a></li> <li><a href="/industry/fda-user-fee-programs" class="lcds-section-nav__section-link lcds-section-nav__link">FDA User Fee Programs</a></li> <li><a href="/industry/import-program" class="lcds-section-nav__section-link lcds-section-nav__link">Import Program</a></li> <li><a href="/industry/industry-notices-and-guidance-documents" class="lcds-section-nav__section-link lcds-section-nav__link">Industry Notices and Guidance Documents</a></li> <li><a href="/industry/small-business-assistance" class="lcds-section-nav__section-link lcds-section-nav__link">Small Business Assistance</a></li> <li><a href="/industry/esg-next-generation" class="lcds-section-nav__section-link lcds-section-nav__link">ESG Next Generation</a></li> </ul> </div> </div> </div> </div> </li> </ul> </nav> </section> <section id="block-entityviewcontent-15" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <ol class="lcds-breadcrumb"> <li> <a href="/" title="Home">Home</a> </li> </ol> </section> <main> <div id="main-content"> <header class='content-header' role="heading" aria-level="1"> <section id="block-entityviewcontent-16" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">For Industry</h1> <h2 class="topic-subtitle text-center">Guidance, registration and listing, pay user fees, import programs, and more.</h2> </div> </section> </header> <div class="field field--name-field-topic-paragraphs field--type-entity-reference-revisions field--label-above"> <div class="field--label">Topic Paragraphs</div> <div class="field--items"> <div class="field--item"> <section class="lcds-cta bg-blue txt-light"> <div class="lcds-cta__media"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/call_to_action_480x270/public/fda-official-speaking-at-industry-conference.jpg?itok=GdmGrO6e 480w" media="all and (max-width: 320px)" type="image/jpeg" sizes="100vw" width="480" height="270"/> <source srcset="/files/styles/call_to_action_480x270/public/fda-official-speaking-at-industry-conference.jpg?itok=GdmGrO6e 480w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" sizes="100vw" width="480" height="270"/> <source srcset="/files/styles/call_to_action_992x558/public/fda-official-speaking-at-industry-conference.jpg?itok=D5vx_K_C 992w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" sizes="100vw" width="992" height="558"/> <source srcset="/files/styles/call_to_action_992x558/public/fda-official-speaking-at-industry-conference.jpg?itok=D5vx_K_C 992w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" sizes="100vw" width="992" height="558"/> <source srcset="/files/styles/call_to_action_992x558/public/fda-official-speaking-at-industry-conference.jpg?itok=D5vx_K_C 992w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" sizes="100vw" width="992" height="558"/> <source srcset="/files/styles/call_to_action_992x558/public/fda-official-speaking-at-industry-conference.jpg?itok=D5vx_K_C 992w" media="all and (min-width: 1201px)" type="image/jpeg" sizes="100vw" width="992" height="558"/> <img loading="eager" src="/files/styles/call_to_action_992x558/public/fda-official-speaking-at-industry-conference.jpg?itok=D5vx_K_C" width="992" height="558" alt="An FDA official giving a presentation at an industry conference" class="img-responsive" /> </picture> </div> </div> </div> <div class="lcds-cta__body"> <h2 class="lcds-cta__title"> FDA Basics for Industry </h2> <p class="lcds-cta__text"> FDA Basics for Industry is aimed at improving communication between FDA and industry by making basic information about the regulatory process more accessible to industry. </p> <a href="/industry/fda-basics-industry" title="/industry/fda-basics-industry" class="btn btn-default"> Learn More </a> </div> </section> </div> <div class="field--item"> <section class="lcds-card-deck--teaser lcds-card-deck txt-dark"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading">Navigate the For Industry Section</h2> </header> <div class="lcds-card-deck__body"> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/industry/import-program" title="Import Program"> Import Program</a></h3> <p class="lcds-card__text">Information for FDA personnel, import brokers, wholesalers, retailers and consumers about import products.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/industry/industry-notices-and-guidance-documents" title="Industry Notices and Guidance Documents">Industry Notices and Guidance Documents</a></h3> <p class="lcds-card__text">Information for industry about FDA guidance documents and notices to industry.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/industry/fda-user-fee-programs" title="User Fees">User Fees</a></h3> <p class="lcds-card__text">How to pay user, registration, facility, certificate, and other fees. Includes cover sheet submission, invoice payment, and refund requests.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/industry/fda-basics-industry" title="FDA Basics for Industry">FDA Basics for Industry</a></h3> <p class="lcds-card__text">Basic information about the regulatory process in an accessible and user-friendly format.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/industry/small-business-assistance" title="Small Business Assistance">Small Business Assistance</a></h3> <p class="lcds-card__text">Contacts for small business assistance.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/industry/medical-products-rare-diseases-and-conditions" title="Developing Products for Rare Diseases & Conditions">Developing Products for Rare Diseases & Conditions</a></h3> <p class="lcds-card__text">Promoting the development of promising products for the diagnosis or treatment of rare diseases or conditions.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/industry/color-additives" title="Color Additives">Color Additives</a></h3> <p class="lcds-card__text">Color additive approval and certification, using color additives in different products, safety information, and more.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/industry/dispute-resolution" title="Dispute Resolution">Dispute Resolution</a></h3> <p class="lcds-card__text">For individuals and companies experiencing problems with the regulatory process or with the application of FDA policies or procedures.</p> </article> </div> </section> </div> <div class="field--item"> <section class="lcds-card-deck--teaser lcds-card-deck txt-dark"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading">Industry Registrations, Submissions, Listings, and More</h2> </header> <div class="lcds-card-deck__body"> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/industry/fda-industry-systems" title="FDA Industry Systems"> FDA Industry Systems</a></h3> <p class="lcds-card__text">FDA Unified Registration and Listing Systems (FURLS), Prior Notice System Interface (PNSI), Import Trade Auxiliary Communication System (ITACS), and more.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/industry/electronic-submissions-gateway" title="Electronic Submissions Gateway">Electronic Submissions Gateway</a></h3> <p class="lcds-card__text">Information on how to submit documents to FDA electronically.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a 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