U.S. Food and Drug Administration

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Before sharing sensitive information, make sure you're on a federal government site.</p> </div> </div> <div class="col-xs-12 col-sm-6 col-md-3"> <img class="usa-banner-icon usa-media_block-img" src="/themes/custom/preview/assets/images/icon-https.svg" alt="SSL" style="width:3em;"> <div class="usa-media_block-body"> <p><strong>The site is secure.</strong><br> The <strong>https://</strong> ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.</p> </div> </div> </div> </div> </div> </div> <div class="alert alert-warning margin-left-neg-2 margin-right-neg-2 margin-top-3 margin-bottom-1"> <p>On Oct. 1, 2024, the FDA began implementing a <a href="/about-fda/fda-organization/fda-modernization-efforts-establishing-unified-human-foods-program-new-model-field-operations-and" title="FDA Modernization Efforts for Establishing a Unified Human Foods Program, New Model for Field Operations and More">reorganization</a> impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.</p> </div> <div class="row fda-masthead"> <div class="col-xs-4 col-md-8"> <a href="/" title="FDA Homepage"> <h1 class="fda-masthead__fda-logo">U.S. Food and Drug Administration</h1> </a> </div> <div class="col-xs-8 col-md-4"> <ul class='fda-masthead__item-list'> <li><a title="" id="btn-search" class="btn btn-default btn-sm fda-masthead__btn-search"> <span class="fa fa-search" aria-hidden="true"> </span> <span class="fda-masthead__btn-label">Search</span> </a></li> <li><a id="menu-btn" class="btn btn-default btn-sm fda-masthead__btn-menu collapsed" href="#primary-nav" data-toggle="collapse" aria-expanded="true"> <span class="fa fa-bars" aria-hidden="true"> </span> <span class='fda-masthead__btn-label'>Menu</span> </a></li> </ul> </div> <form class="fda-masthead__search sr-only" role="search" action="/search" method="GET" name="searchForm" id="search-form" accept-charset="UTF-8" > <div class="search-popover" 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id="main-content"> <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-feature"> <div class="lcds-feature__image"> <picture> <img src="/files/styles/featured_content_background_image/public/food_poisoning.jpg?itok=-bBS7YJF" alt="Holidays Are A Time To Share"> </picture> </div> <div class="lcds-feature__content"> <a href="/food/buy-store-serve-safe-food/safe-food-handling" title="Holidays Are A Time To Share"> <p class="lcds-feature__label">Featured</p> <h2 class="lcds-feature__title"> Holidays Are A Time To Share </h2> <p class="lcds-feature__text"> Just don’t share “food poisoning” with your friends and family. </p> </a> </div> </section> </div> <div class="field--item"> <section class="lcds-card-deck--promoted lcds-card-deck bg-lightest-gray"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading sr-only">Featured Topics</h2> </header> <div class="lcds-card-deck__body"> <a href="/food/alerts-advisories-safety-information/investigation-avian-influenza-h5n1-virus-dairy-cattle" title="Highly Pathogenic Avian Influenza (HPAI)"> <article class="lcds-card lcds-card--promoted bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/highly_pathogenic_avian_influenza_hpai.png?itok=oDJmFVoa 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/highly_pathogenic_avian_influenza_hpai.png?itok=oDJmFVoa 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/highly_pathogenic_avian_influenza_hpai.png?itok=HHOfEdc7 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/highly_pathogenic_avian_influenza_hpai.png?itok=HHOfEdc7 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/highly_pathogenic_avian_influenza_hpai.png?itok=HHOfEdc7 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/highly_pathogenic_avian_influenza_hpai.png?itok=HHOfEdc7 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/highly_pathogenic_avian_influenza_hpai.png?itok=HHOfEdc7" width="420" height="220" alt="Updates on Highly Pathogenic Avian Influenza" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Highly Pathogenic Avian Influenza (HPAI)</h3> <p class="lcds-card__text">FDA’s Response to Ensure Continued Effectiveness of Federal-State Milk Safety System</p> </div> </article> </a> <a href="/consumers/consumer-updates/know-when-and-how-use-antibiotics-and-when-skip-them" title="Know When and How to Use Antibiotics, and When to Skip Them"> <article class="lcds-card lcds-card--promoted bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/how_to_use_antibiotics_cu_final_1600x900.png?itok=bnfhcop0 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/how_to_use_antibiotics_cu_final_1600x900.png?itok=bnfhcop0 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/how_to_use_antibiotics_cu_final_1600x900.png?itok=LgFjllkT 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/how_to_use_antibiotics_cu_final_1600x900.png?itok=LgFjllkT 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/how_to_use_antibiotics_cu_final_1600x900.png?itok=LgFjllkT 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/how_to_use_antibiotics_cu_final_1600x900.png?itok=LgFjllkT 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/how_to_use_antibiotics_cu_final_1600x900.png?itok=LgFjllkT" width="420" height="220" alt="Two image collage that depicts a mature gentleman holding his prescription pill bottles, while viewing his laptop, and a woman sneezing while she's speaking with a pharmacist." class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Know When and How to Use Antibiotics, and When to Skip Them</h3> <p class="lcds-card__text">Antibiotics are powerful medications that save countless lives every day. But they’re not the answer for every illness.</p> </div> </article> </a> <a href="/about-fda/fda-organization/fda-modernization-efforts-establishing-unified-human-foods-program-new-model-field-operations-and" title="FDA Modernization Efforts for Establishing a Unified Human Foods Program"> <article class="lcds-card lcds-card--promoted bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/hfp_tile.png?itok=S08B2gwK 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/hfp_tile.png?itok=S08B2gwK 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/hfp_tile.png?itok=vV-GYjSO 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/hfp_tile.png?itok=vV-GYjSO 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/hfp_tile.png?itok=vV-GYjSO 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/hfp_tile.png?itok=vV-GYjSO 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/hfp_tile.png?itok=vV-GYjSO" width="420" height="220" alt="FDA Modernization Efforts for a Unified Human Foods Program, Redesigned Field Operations & More" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">FDA Modernization Efforts for Establishing a Unified Human Foods Program</h3> <p class="lcds-card__text">The unified Human Foods Program, a new model and name for field operations and other modernization efforts are now in effect.</p> </div> </article> </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">Products We Regulate</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="/food" title="Food"> Food</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/drugs" title="Drugs">Drugs</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/medical-devices" title="Medical Devices">Medical Devices</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/radiation-emitting-products" title="Radiation-Emitting Products">Radiation-Emitting Products</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/vaccines-blood-biologics" title="Vaccines, Blood, and Biologics">Vaccines, Blood, and Biologics</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/animal-veterinary" title="Animal and Veterinary">Animal and Veterinary</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/cosmetics" title="Cosmetics">Cosmetics</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/tobacco-products" title="Tobacco Products">Tobacco Products</a></h3> <p class="lcds-card__text"></p> </article> <div class="btn-container"> <a href="https://www.safetyreporting.hhs.gov/smarthub#/" title="Report a Problem with an FDA Regulated Product" class="btn btn-default">Report a Problem with an FDA Regulated Product</a> </div> </div> </section> </div> <div class="field--item"> <div class="paragraph paragraph--type--recent-press-announcements paragraph--view-mode--default"> <section class="lcds-card-deck lcds-card-deck--vertical bg-lightest-gray txt-dark"> <div class="field field--name-field-title field--type-string field--label-hidden field--item"><div class="views-element-container form-group"><div class="view view-recent-press-announcements-paragraph view-id-recent_press_announcements_paragraph view-display-id-default js-view-dom-id-fff44aa90e306a0a2979a56bb58cd674120addf53dc7adf7a08a6ed6422af3ca"> <div class="view-header"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading">Recent Press Announcements</h2> </header> </div> <div class="view-content"> <div class="lcds-card-deck__body"> <article class="lcds-card"> <p class="lcds-card__label"> Nov 26 </p> <h3 class="lcds-card__title"> <a href="/news-events/press-announcements/fda-roundup-november-26-2024" title="FDA Roundup: November 26, 2024">FDA Roundup: November 26, 2024</a> </h3> </article> <article class="lcds-card"> <p class="lcds-card__label"> Nov 22 </p> <h3 class="lcds-card__title"> <a href="/news-events/press-announcements/fda-roundup-november-22-2024" title="FDA Roundup: November 22, 2024">FDA Roundup: November 22, 2024</a> </h3> </article> <div> <a href="/news-events/fda-newsroom/press-announcements" title="More Press Announcements" class="btn btn-default">More Press Announcements</a> </div> </div> </div> </div> </div> </div> </section> </div> </div> <div class="field--item"> <section 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view-display-id-default js-view-dom-id-de67a4c0c974305074e61821d5babd98bf7546dd15d35d212a1815a57e097df8"> <div class="view-header"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading">Recalls, Market Withdrawals, & Safety Alerts</h2> <p class="lcds-card-deck__heading-text">Alerting you to the latest recalls of potentially unsafe FDA-regulated products gathered from press releases and other public notices. Not all recalls have press releases or are posted on this website.</p> </header> </div> <div class="view-content"> <div class="lcds-card-deck__body"> <article class="lcds-card"> <p class="lcds-card__label"> Nov 28 </p> <h3 class="lcds-card__title"> <a href="/safety/recalls-market-withdrawals-safety-alerts/gracies-kitchens-inc-recalls-read-eat-products-manufactured-between-114-and-111324-because-possible" title="Gracie’s Kitchen’s Inc. Recalls Read-To-Eat Products Manufactured Between 11/4 and 11/13/24 Because of Possible Health Risk">Gracie’s Kitchen’s Inc. Recalls Read-To-Eat Products Manufactured Between 11/4 and 11/13/24 Because of Possible Health Risk</a> </h3> <p class="lcds-card__label"> Food & Beverages </p> </article> <article class="lcds-card"> <p class="lcds-card__label"> Nov 27 </p> <h3 class="lcds-card__title"> <a href="/safety/recalls-market-withdrawals-safety-alerts/handsome-brook-farms-issues-recall-kirkland-signature-organic-pasture-raised-24-count-eggs-because" title="Handsome Brook Farms Issues Recall of Kirkland Signature Organic Pasture Raised 24-Count Eggs Because of Possible Health Risk">Handsome Brook Farms Issues Recall of Kirkland Signature Organic Pasture Raised 24-Count Eggs Because of Possible Health Risk</a> </h3> <p class="lcds-card__label"> Food & Beverages </p> </article> <article class="lcds-card"> <p class="lcds-card__label"> Nov 27 </p> <h3 class="lcds-card__title"> <a href="/safety/recalls-market-withdrawals-safety-alerts/4earth-farms-llc-recalls-organic-and-conventional-vegetable-medleys-and-organic-whole-carrots" title="4Earth Farms, LLC. Recalls Organic and Conventional Vegetable Medleys and Organic Whole Carrots, Containing Grimmway Farms Carrots, Because of Possible Health Risk">4Earth Farms, LLC. Recalls Organic and Conventional Vegetable Medleys and Organic Whole Carrots, Containing Grimmway Farms Carrots, Because of Possible Health Risk</a> </h3> <p class="lcds-card__label"> Food & Beverages </p> </article> </div> </div> </div> </div> </div> <div> <a href="/safety/recalls-market-withdrawals-safety-alerts" title="More Recalls Market Withdrawals & Safety Alerts" class="btn btn-default">More Recalls Market Withdrawals & Safety Alerts</a> <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=subscription.login" title="Subscribe to the Enforcement Report Mailing List" class="btn btn-default">Subscribe to the Enforcement Report Mailing List</a> </div> </section> </div> </div> <div class="field--item"> <div> <section class="lcds-card-deck--promoted lcds-card-deck bg-lightest-gray"> <div class="field field--name-field-title field--type-string field--label-above"> <div class="field--label">Paragraph Header</div> <div class="field--item"><div class="views-element-container form-group"><div class="view view-fda-voices-paragraph view-id-fda_voices_paragraph view-display-id-block_1 js-view-dom-id-24fc39724bc1a6d7b8ef5d73573a9a385c1a34d6c845689a7c30406b17afc619"> <div class="view-content"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading">FDA VOICES: PERSPECTIVES FROM FDA EXPERTS</h2> </header> <div class="lcds-card-deck__body"> <a href="/news-events/fda-voices/upholding-public-trust-fda-office-criminal-investigations-crucial-role-bringing-drug-criminals" title="Upholding Public Trust: FDA Office of Criminal Investigations’ Crucial Role in Bringing Drug Criminals to Justice"> <article class="lcds-card lcds-card--promoted bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/restoring_public_trust_1600x900.png?itok=kZS-98IS 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/restoring_public_trust_1600x900.png?itok=kZS-98IS 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/restoring_public_trust_1600x900.png?itok=i1G_BRqw 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/restoring_public_trust_1600x900.png?itok=i1G_BRqw 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/restoring_public_trust_1600x900.png?itok=i1G_BRqw 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/restoring_public_trust_1600x900.png?itok=i1G_BRqw 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/restoring_public_trust_1600x900.png?itok=i1G_BRqw" width="420" height="220" alt="Illustrated graphic with Office of Criminal Investigations seal on right. On left is icons representing cyber security, inspections, data, air and shipping transportation." class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title"> Upholding Public Trust: FDA Office of Criminal Investigations’ Crucial Role in Bringing Drug Criminals to Justice </h3> <p class="lcds-card__text">OCI investigators have been conducting and coordinating criminal investigations of suspected illegal activities involving FDA-regulated products.</p> </div> </article> </a> <a href="/news-events/fda-voices/one-health-optimal-public-health-outcomes-humans-and-animals-our-shared-environment" title="One Health - Optimal Public Health Outcomes for Humans and Animals in Our Shared Environment"> <article class="lcds-card lcds-card--promoted bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/CUwC_FINAL.png?itok=ZzC6cxWN 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/CUwC_FINAL.png?itok=ZzC6cxWN 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/CUwC_FINAL.png?itok=1dXZ-xBq 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/CUwC_FINAL.png?itok=1dXZ-xBq 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/CUwC_FINAL.png?itok=1dXZ-xBq 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/CUwC_FINAL.png?itok=1dXZ-xBq 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/CUwC_FINAL.png?itok=1dXZ-xBq" width="420" height="220" alt="Catching Up with Califf Main Image includes photo of Dr. Califf" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title"> One Health - Optimal Public Health Outcomes for Humans and Animals in Our Shared Environment </h3> <p class="lcds-card__text">FDA collaborates with stakeholders across disciplines and sectors to promote the health of humans, animals, and the environment.</p> </div> </article> </a> <a href="/news-events/fda-voices/fda-takes-exciting-steps-toward-establishing-rare-disease-innovation-hub" title="FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub"> <article class="lcds-card lcds-card--promoted bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/fda_rdih_1600x900_0.jpg?itok=C_mjpGHf 380w" media="all and (max-width: 320px)" type="image/jpeg" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/fda_rdih_1600x900_0.jpg?itok=C_mjpGHf 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/fda_rdih_1600x900_0.jpg?itok=SEIcraSD 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/fda_rdih_1600x900_0.jpg?itok=SEIcraSD 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/fda_rdih_1600x900_0.jpg?itok=SEIcraSD 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/fda_rdih_1600x900_0.jpg?itok=SEIcraSD 420w" media="all and (min-width: 1201px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/fda_rdih_1600x900_0.jpg?itok=SEIcraSD" width="420" height="220" alt="Rare Disease Innovation Hub background with DNA strands and FDA monogram logo." class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title"> FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub </h3> <p class="lcds-card__text">The Hub will act as the single point of engagement and connection with outside parties for drug and biological product development.</p> </div> </article> </a> </div> </div> </div> </div> </div> </div> <div> <a href=" https://www.fda.gov/news-events/fda-newsroom/fda-voices" title="View More" class="btn btn-default">View More...</a> </div> </section> </div> </div> <div class="field--item"> <div class="paragraph paragraph--type--recently-published-guidances paragraph--view-mode--default"> <section class="lcds-card-deck lcds-card-deck--horizontal txt-dark"> <div class="field field--name-field-title field--type-string field--label-hidden field--item"><div class="views-element-container form-group"><div class="view view-recently-published-guidances view-id-recently_published_guidances view-display-id-default js-view-dom-id-9ce9ccbe7c2cb7d6efcf6fa7eb95671092cb8f2a0888cbaa88baee37ece46d6b"> <div class="view-header"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading">Recently Published Guidances</h2> </header> </div> <div class="view-content"> <div class="lcds-card-deck__body"> <article class="lcds-card"> <p class="lcds-card__label"> Nov 27 </p> <h3 class="lcds-card__title"> <a href="/regulatory-information/search-fda-guidance-documents/recommended-followup-testing-ames-positive-drug-active-ingredient-or-metabolite-support-first-human" title="Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects">Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects</a> </h3> <p class="lcds-card__label"> Drugs </p> </article> <article class="lcds-card"> <p class="lcds-card__label"> Nov 27 </p> <h3 class="lcds-card__title"> <a href="/regulatory-information/search-fda-guidance-documents/use-circulating-tumor-deoxyribonucleic-acid-early-stage-solid-tumor-drug-development-guidance" title="Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Guidance for Industry; Availability">Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Guidance for Industry; Availability</a> </h3> <p class="lcds-card__label"> </p> </article> <article class="lcds-card"> <p class="lcds-card__label"> Nov 26 </p> <h3 class="lcds-card__title"> <a href="/regulatory-information/search-fda-guidance-documents/assessment-ovarian-toxicity-premenopausal-adults-during-drug-development-oncologic-products" title="Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products ">Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products </a> </h3> <p class="lcds-card__label"> Biologics, Drugs </p> </article> <div> <a href="/regulatory-information/search-fda-guidance-documents" title="FDA Guidance Search" class="btn btn-default">FDA Guidance Search</a> </div> </div> </div> </div> </div> </div> </section> </div> </div> <div class="field--item"> <section class="lcds-card-deck--teaser lcds-card-deck bg-lightest-gray txt-dark"> <header 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