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Investigational New Animal Drug (INAD) Guidances | FDA

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Analysis">CVM GFI #226 Target Animal Safety Data Presentation and Statistical Analysis</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="af29c9e1-c73b-4a5f-a0ba-cd46df7c447a" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-227-chemistry-manufacturing-and-controls-cmc-technical-section-filing-strategies" title="CVM GFI #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies">CVM GFI #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="08e553c8-91fb-448d-8929-d482711e4658" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-237-oncology-drugs-companion-animals" title="CVM GFI #237 Oncology Drugs for Companion Animals">CVM GFI #237 Oncology Drugs for Companion Animals</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="0e70e2f9-b924-49f3-8493-433272d48fa7" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-242-use-stability-studies-and-associated-labeling-statements-multiple-dose-injectable-animal" title="CVM GFI #242 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products">CVM GFI #242 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="80e10d61-bd79-4947-92c0-00a3e1722b94" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-253-current-good-manufacturing-practice-animal-cells-tissues-and-cell-and-tissue-based" title="CVM GFI #253 Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products">CVM GFI #253 Current Good Manufacturing Practice&nbsp;for Animal Cells, Tissues, and Cell- and Tissue-Based Products</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="227598ba-5c3c-49d5-98ab-46ce26d4421d" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-254-donor-eligibility-animal-cells-tissues-and-cell-and-tissue-based-products" title="CVM GFI #254 Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products">CVM GFI #254 Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c4bb1e56-d65d-4595-9777-74d17e6bbb16" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-258-use-tracers-animal-food-type-medicated-articles-and-medicated-feeds" title="CVM GFI #258 Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds">CVM GFI #258 Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="f8a77314-ad5c-430f-9192-1a048ad04ccd" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-264-standardized-medicated-feed-assay-limits" title="CVM GFI #264 Standardized Medicated Feed Assay Limits">CVM GFI #264 Standardized Medicated Feed Assay Limits</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="06d4dc4b-e328-4394-ae32-a58b42f4a3df" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-265-use-data-foreign-investigational-studies-support-effectiveness-new-animal-drugs" title="CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs">CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="d3cb23da-67a0-4ec1-867c-60009b4d1299" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-266-use-real-world-data-and-real-world-evidence-support-effectiveness-new-animal-drugs" title="CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs">CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="9294f38f-e1b5-4bee-9da6-947146072a26" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-267-biomarkers-and-surrogate-endpoints-clinical-studies-support-effectiveness-new-animal" title="CVM GFI #267 Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs">CVM GFI #267 Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" 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data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c93dedb0-dd54-43dc-8b01-95c504f0568d" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-278-human-user-safety-new-and-abbreviated-new-animal-drug-applications" title="CVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug Applications">CVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug Applications</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="264431d8-40dd-46b4-964b-1d14e0810722" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-279-demonstrating-bioequivalence-type-medicated-articles-containing-active-pharmaceutical" title="CVM GFI #279 Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting">CVM GFI #279 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Animals">CVM GFI #282 Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ef7956de-e2d3-43ae-afb1-71d9e77945a4" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-283-priority-zoonotic-animal-drug-designation-and-review-process" title="CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review Process">CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review Process</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="3655ec28-2ac2-4678-8356-41d002c42767" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-285-manufacture-batches-support-original-nadas-anadas-and-cnadas" title="CVM GFI #285 - Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs">CVM GFI #285 Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs</a></li> <li><a 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data-entity-uuid="f0060461-9837-414a-a632-cc0fa25bfab9" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-288-chemistry-manufacturing-and-controls-support-recombinant-protein-products-veterinary" title="CVM GFI #288 Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use">CVM GFI #288 Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="109fb3e4-ad13-41b1-a02a-ff2ac0e0e190" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-290-vich-gl61-pharmaceutical-development" title="CVM GFI #290 (VICH GL61) – Pharmaceutical Development">CVM GFI #290 (VICH GL61) – Pharmaceutical Development</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="7846cd9a-63ac-4bf5-ab38-c7299650ce64" href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-292-chemistry-manufacturing-and-controls-considerations-type-medicated-articles" title="CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles">CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles</a></li> </ul> <p>&nbsp;</p> <!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET--> <!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET--> </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p 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