Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products

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for Oncologic Products </a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/regulatory-information/search-fda-guidance-documents" title="Search for FDA Guidance Documents"> Search for FDA Guidance Documents </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-11" 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"> <p class="content-type-label text-center">GUIDANCE DOCUMENT</p> <h1 class="text-center content-title">Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products <span class="article-subtitle text-center"></span> <span class="font-family-sans">November 2024</span> </h1> <div class="lcds-toolbar text-center"> <a class="btn btn-primary" href="/media/183839/download">Download the Draft Guidance Document</a> <a class="btn btn-primary" href="https://www.federalregister.gov/public-inspection/2024-27804/guidance-assessment-of-ovarian-toxicity-in-premenopausal-adults-during-drug-development-for">Read the Federal Register Notice</a> </div> <div class="lcds-statusbar text-center"> <span class="label label-default">Draft</span> </div> <p class="lcds-explainer-txt text-center">Not for implementation. 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href="https://www.regulations.gov/docket/FDA-2024-D-4643">FDA-2024-D-4643</a></dd> <dt class="cell-1_2">Issued by:</dt> <dd class="cell-2_2"><a href="/regulatory-information/search-fda-guidance-documents/assessment-ovarian-toxicity-premenopausal-adults-during-drug-development-oncologic-products"></a> <div class="field field--name-field-issuing-office-taxonomy field--type-entity-reference field--label-above"> <div class="field--label">Guidance Issuing Office</div> <div class="field--items"> <div class="field--item">Oncology Center of Excellence</div> <div class="field--item">Center for Drug Evaluation and Research</div> <div class="field--item">Center for Biologics Evaluation and Research</div> </div> </div> </dd> </dl> </div> <p>This draft guidance provides recommendations to sponsors regarding the measurement of ovarian toxicity using clinical measures and biomarkers of ovarian function in relevant cancer clinical trials that enroll premenopausal adults with ovaries.</p> <div 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Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products | FDA