Guidances

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<li><a href="#GGP">Reports on Good Guidance Practices</a></li> <li><a href="#Comments">Commenting on Guidance Documents</a></li> <li><a href="#Agendas">Guidance Agendas</a></li> <li><a href="#How to">How to Provide Input into Topics for Guidance Development</a></li> <li><a href="#Withdrawn">Withdrawn Guidance Documents</a></li> <li><a href="#Additional">Additional Resources</a></li> <li><a href="#Subscribe">Subscribe to Email Updates</a></li> </ul> </div> <p>Guidance documents describe FDA’s interpretation of or policy on a regulatory issue (21 CFR 10.115(b)). In general, FDA’s guidance documents do not establish legally enforceable responsibilities and thus are not binding on FDA or the public. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. </p> <h3><a id="Search" name="Search"></a>Search for FDA Guidance Documents</h3> <p>This feature is provided to give a convenient way to search for all FDA guidance documents from a single location.</p> <p><a class="btn btn-primary" href="https://www.fda.gov/search-fda-guidance-documents"><span class="text">Search for FDA Guidance Documents</span></a></p> <hr style="width: 80%"> <div class=" panel-group" id="accordion_007357" role="tablist" aria-multiselectable="true"> <p><a id="About" name="About"></a> </p><div title="About FDA Guidance Documents" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674ef13f008e3"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674ef13f008e3" aria-controls="674ef13f008e3">About FDA Guidance Documents</a> </h2> </div> <div id="674ef13f008e3" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674ef13f008e3"> <div class="panel-body"> <p>Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public.  You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. For further background on FDA's Good Guidance Practices, please visit <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="417b87a2-8ec0-4fb7-a6c5-884ac053e012" href="/regulatory-information/guidances/background-fda-good-guidance-practices" title="Background: FDA Good Guidance Practices">Background: FDA Good Guidance Practices</a>.</p> <p>If you believe an FDA employee is not following FDA's <a href="http://www.ecfr.gov/cgi-bin/text-idx?SID=7c0a5352a78ff3516507e550a9d5487d&mc=true&node=se21.1.10_1115&rgn=div8" target="_blank">Good Guidance Practice regulations</a> (21 CFR 10.115), you should contact the employee's supervisor in the issuing office or Center.  If the issue is not resolved, contact the next highest supervisor or the Center's Ombudsman.  If the issue is still not resolved, contact the FDA's Office of the Ombudsman at:</p> <p>FDA Office of the Ombudsman<br> 10903 New Hampshire Avenue<br> WO Bldg. 1, room 4208<br> Silver Spring, MD 20993<br> Phone: 301-796-8530<br> Email:  <a href="mailto:Ombuds@oc.fda.gov">Ombuds@oc.fda.gov</a></p> <p>Some Web links (URLs) embedded within guidance documents may have changed since the document was published. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to <a href="/contact-fda-1" target>Contact FDA</a>.</p> </div> </div> </div> <p><a id="GGP" name="GGP"></a> </p><div title="Reports on Good Guidance Practices" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674ef13f0148d"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674ef13f0148d" aria-controls="674ef13f0148d">Reports on Good Guidance Practices</a> </h2> </div> <div id="674ef13f0148d" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674ef13f0148d"> <div class="panel-body"> <p>In 2011, a cross-Agency working group prepared a report identifying FDA's “best practices” and making recommendations to streamline the development of guidance documents, reduce the time between issuing draft and final guidance documents, and make it easier to find guidance documents on FDA’s website.<br> <a href="https://www.fda.gov/media/82644/download">2011 Report on Good Guidance Practices: Improving Efficiency and Transparency</a></p> <p>In 2023, pursuant to section 2505(a) of the Consolidated Appropriations Act, 2023 FDA prepared for public comment a draft document entitled “Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance” identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents and a plan for implementation of such best practices.  <br> <a href="https://www.fda.gov/media/175121/download?attachment">2023 Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance</a><br> <a href="https://www.govinfo.gov/content/pkg/FR-2024-01-03/pdf/2023-28872.pdf">Federal Register Notice Announcing availability of the Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance</a></p> <p>Consistent with section 2505(c) of the Consolidated Appropriations Act, 2023, FDA solicited public comment on the Draft Report and Plan from a broad range of interested parties. Following the close of the public comment period, FDA prepared the final report and plan, available below.</p> <p>Click to download: <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="bfd9dc1e-f199-4f02-8f15-0e6d4cacc27c" href="/media/183214/download?attachment" title="fdora_2505_final_report_508ed">Food and Drug Administration Report and Plan on Best Practices for Guidance</a></p>  <p>For more information on FDA Reports on Good Guidance Practices, please visit <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="50f167b4-e83e-485a-a032-a1587950fbd0" href="/regulatory-information/guidances/fda-reports-good-guidance-practices" title="FDA Reports on Good Guidance Practices ">FDA Reports on Good Guidance Practices</a>.</p> </div> </div> </div> <p><a id="Comments" name="Comments"></a> </p><div title="Commenting on Guidance Documents" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674ef13f01550"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674ef13f01550" aria-controls="674ef13f01550">Commenting on Guidance Documents</a> </h2> </div> <div id="674ef13f01550" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674ef13f01550"> <div class="panel-body"> <p>Some FDA guidance documents on the Search for FDA Guidance Documents webpage are indicated as open for comment. Although you can comment on any guidance at any time (see <a href="http://www.ecfr.gov/cgi-bin/text-idx?SID=7c0a5352a78ff3516507e550a9d5487d&mc=true&node=se21.1.10_1115&rgn=div8" target="_blank">21 CFR 10.115(g)(5)</a>), to ensure that the Agency considers your comment on a draft guidance that is open for comments before it begins work on the final version of the guidance, submit either electronic or written comments by the closing date. Comments are submitted electronically through regulations.gov. For more information, see:</p> <ul> <li><a href="/regulatory-information/federal-register-fr-notices/how-use-regulationsgov" target>How to Use Regulations.gov</a></li> <li><a href="/find-and-comment-fda-dockets" target>Find and Comment on FDA Dockets</a></li> </ul> </div> </div> </div> <p><a id="Agendas" name="Agendas"></a> </p><div title="Guidance Agendas" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674ef13f01606"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674ef13f01606" aria-controls="674ef13f01606">Guidance Agendas</a> </h2> </div> <div id="674ef13f01606" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674ef13f01606"> <div class="panel-body"> <p>Center and Office Guidance Agendas are available through the links below:</p> <p>Animal and Veterinary</p> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="013f8038-3872-437d-9c7c-ce7b372c5627" href="/animal-veterinary/guidance-industry/guidances-under-development" title="Guidances Under Development">Center for Veterinary Medicine Guidance Documents Under Development</a></li> </ul> <p>Foods Program</p> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="efe22099-7563-4bc4-b167-801c03134dad" href="/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/foods-program-guidance-under-development" title="Foods Program Guidance Under Development">Foods Program Guidance Under Development</a></li> </ul> <p>Medical Devices and Radiation-Emitting Products</p> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4a69c707-c3cb-424a-8e79-4bb67262953f" href="/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidance-development" title="CDRH Proposed Guidance Development">Center for Devices and Radiological Health Proposed Guidance Development</a></li> </ul> <p>Drugs</p> <ul> <li><a href="https://www.fda.gov/media/134778/download">CDER Guidance Agenda New, Revised Draft and Immediately in Effect Guidances Planned for Publication in Calendar Year 2024</a></li> </ul> <p>Office of the Chief Scientist</p> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="44432eb0-1a39-4793-9115-51227782f6ce" href="/about-fda/guidance-documents-office-chief-scientist/office-chief-scientist-guidance-documents-under-development" title="Office of the Chief Scientist Guidance Documents Under Development">Office of the Chief Scientist Guidance Documents Under Development</a></li> </ul> <p>Tobacco</p> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="d7cbeafd-7697-40a1-9a11-2ae2196b4770" href="/tobacco-products/rules-regulations-and-guidance-related-tobacco-products/center-tobacco-products-regulation-and-guidance-policy-agenda" title="Center for Tobacco Products’ Regulation and Guidance Policy Agenda">Center for Tobacco Products' Regulation and Guidance Policy Agenda</a></li> </ul> <p>Vaccines, Blood & Biologics</p> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="427fe6f1-ba5e-48aa-a3e4-12240520c4e2" href="/vaccines-blood-biologics/biologics-guidances/guidance-agenda-guidance-documents-cber-planning-publish-during-calendar-year-2024" title="Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2024">Guidance Agenda: Guidance Documents CBER is Planning to the Publish During the Calendar Year</a></li> </ul> </div> </div> </div> <p><a id="How to" name="How to"></a> </p><div title="How to Provide Input into Topics for Guidance Development" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674ef13f016db"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674ef13f016db" aria-controls="674ef13f016db">How to Provide Input into Topics for Guidance Development</a> </h2> </div> <div id="674ef13f016db" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674ef13f016db"> <div class="panel-body"> <p>There are several opportunities to provide input on topics for guidance document development, including topics for potential future guidance documents, via formal and informal channels.  FDA Centers and Offices publish annual Guidance Agendas, which list possible topics for future guidance document development or revision during the upcoming year. However, the guidance development process is fluid and changes depending on public health needs and Agency resources. The Guidance Agendas do not bind FDA to a list of topics or obligate FDA to issue every guidance document on an Agenda, especially given that competing priorities may arise during the year. In addition, a Center or Office is not precluded from issuing guidance documents on topics that are not listed on their Guidance Agendas.  </p> <p>Beginning in January 2025, for those Centers and Offices that issue a guidance agenda on a Calendar Year basis, FDA will publish a Notice of Availability in the Federal Register announcing the availability of annual Guidance Agendas and providing information about how to comment on the Agenda.  </p> <p>You can suggest areas for guidance document development by commenting on a Guidance Agenda or by contacting the Center or Office that is responsible for the regulatory activity covered by the guidance document. Your suggestions should address why a guidance document is necessary. </p> <p>You can submit drafts of proposed guidance documents for FDA to consider. To submit a draft proposed guidance document, mark the document “Guidance Document Submission” and submit it electronically through <a href="https://www.regulations.gov">https://www.regulations.gov</a> at Docket No. FDA-2013-S-0610 or send it to Dockets Management Staff (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  </p> <p>You can, at any time, suggest that FDA revise or withdraw a guidance document by contacting the Center or Office that is responsible for the regulatory activity covered by the guidance document. Your suggestion should address why the guidance document should be revised or withdrawn and, if applicable, how it should be revised. </p> </div> </div> </div> <p><a id="Withdrawn" name="Withdrawn"></a> </p><div title="Withdrawn Guidance Documents" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674ef13f0177e"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674ef13f0177e" aria-controls="674ef13f0177e">Withdrawn Guidance Documents</a> </h2> </div> <div id="674ef13f0177e" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674ef13f0177e"> <div class="panel-body"> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="380fdc75-68a2-432f-a531-2d5fdd939287" href="/animal-veterinary/guidance-industry/withdrawnreplaced-guidances" title="Withdrawn/Replaced Guidances">Animal and Veterinary</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ebc3415b-cbf9-4051-b3a9-0f0e1b5e85e5" href="/regulatory-information/search-fda-guidance-documents/withdrawn-guidances-biologics" title="Withdrawn Guidances (Biologics)">Biologics</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ba0b5359-48da-413c-8e8d-be9adbf44628" href="/science-research/clinical-trials-and-human-subject-protection/withdrawn-or-expired-clinical-trial-guidance-documents" title="Withdrawn or Expired Clinical Trial Guidance Documents">Clinical Trials</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="439849db-c696-47e8-bc7f-d4ff6ba47179" href="/drugs/guidances-drugs/withdrawn-and-expired-guidances-drugs" title="Withdrawn and Expired Guidances | Drugs">Drugs</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="bc100553-3ea0-4a6c-b334-fcc4bd2413c6" href="/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/foods-program-withdrawn-or-expired-guidance" title="Foods Program Withdrawn or Expired Guidance">Foods</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="3fb12a30-4149-4b39-8af7-0ee03b47b53e" href="/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/withdrawn-or-expired-guidance" title="Withdrawn or Expired Guidance">Medical Devices</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="b90d53d8-0b79-4674-bfcb-cc48e33c2b9c" href="/tobacco-products/rules-regulations-and-guidance-related-tobacco-products/withdrawnreplaced-guidances" title="Withdrawn/Replaced Guidances">Tobacco</a></li> </ul> </div> </div> </div> </div> <hr style="width: 80%"> <h3><strong><a id="Additional" name="Additional"></a>Additional Resources</strong></h3> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="09ef5ff5-f8f2-4d5f-af71-5b7ee4483536" href="/about-fda/reports/fda-reports-good-guidance-practices" title="FDA Reports on Good Guidance Practices ">FDA Reports on Good Guidance Practices</a></li> <li><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=10.115">Good Guidance Practices Regulation</a></li> <li><a href="https://www.reginfo.gov/public/">RegInfo Dashboard - 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