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col-md-offset-2"> <h1 class="content-title text-center">Guidance Snapshot Pilot</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fdrugs%2Fguidances-drugs%2Fguidance-snapshot-pilot" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=Guidance%20Snapshot%20Pilot&url=https://www.fda.gov%2Fdrugs%2Fguidances-drugs%2Fguidance-snapshot-pilot" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li class="lcds-share__item hidden-xs"> <a 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<h2>Guidance Snapshots at a glance</h2><p>FDA guidance documents contain the Agency’s current best thinking on a particular topic. To support transparent communication and dissemination of FDA guidance documents, FDA is launching the Guidance Snapshot Pilot for a subset of cross-cutting guidance documents on topics that seek to modernize drug clinical trials and accelerate drug development. Guidance Snapshots are a communication tool that provide highlights from guidance documents using visuals and plain language. This pilot program is intended to increase general public awareness and engagement for FDA guidance documents on innovative topics to support the efficient application of the guidance documents’ recommendations.</p><p></p><div class=" panel-group" id="accordion_121849" role="tablist" aria-multiselectable="true"><p> </p><div title="How to read Guidance Snapshots" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_67b400ef1d083"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#67b400ef1d083" aria-controls="67b400ef1d083">How to read Guidance Snapshots</a> </h2> </div> <div id="67b400ef1d083" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_67b400ef1d083"> <div class="panel-body"> <p>Guidance Snapshots are a communication tool that provide highlights from guidance documents using visuals and plain language to support transparent communication and dissemination of FDA guidance documents. During the Pilot, Guidance Snapshots will contain a subset of the following key features:</p><ul><li>Explanation of why the guidance document is important</li><li>Highlights from the guidance document</li><li>Educational background about the guidance topic</li><li>Link to the full guidance document</li><li>Drug development timeline for when to apply the guidance recommendations</li><li>Guidance Recap Podcast that describes highlights and background the guidance document explained directly from the authors</li><li>Twitter hashtags to create a platform for discussing views on the guidance</li><li>Link to the FDA docket for providing official comments to the Agency (for applicable draft guidances)</li></ul><p> </p></div> </div> </div><p> </p><div title="Limitations of Guidance Snapshots" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_67b400ef1d7bd"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#67b400ef1d7bd" aria-controls="67b400ef1d7bd">Limitations of Guidance Snapshots</a> </h2> </div> <div id="67b400ef1d7bd" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_67b400ef1d7bd"> <div class="panel-body"> <p>Guidance Snapshots are a communication tool intended to increase general public awareness and engagement for FDA guidance documents. Guidance Snapshots are not a substitute for the guidance document. Guidance Snapshots should not be used to make drug development decisions.</p><p> </p></div> </div> </div><p></p></div><hr><p></p><div class="row"><p></p><div class=" col-md-6 col-lg-6"> <h2>Guidance Snapshots</h2><p> </p></div> <p></p><div class=" col-md-6 col-lg-6"> <p><a class="no-disclaimer" href="https://podcasts.apple.com/us/podcast/fda-guidance-recap-podcast/id1646184051" target="_blank"><img style="float:right;" alt="Listen on Apple Podcasts" src="/media/155035/download" title="Listen on Apple Podcasts"></a></p><p> </p></div> <p></p></div> <div class="table-responsive"><table class="table table-striped table-bordered" summary="Guidance Snapshots"><thead><tr><th scope="col">Guidance Document</th><th scope="col">Guidance Snapshot</th><th scope="col">Guidance Recap Podcast</th><th scope="col">Podcast Transcript</th><th scope="col">Guidance Type</th><th scope="col">Guidance Issue Date</th></tr></thead><tbody><tr><td><a href="/regulatory-information/search-fda-guidance-documents/considerations-long-term-clinical-neurodevelopmental-safety-studies-neonatal-product-development" data-entity-type="node" data-entity-uuid="19dac90e-8af5-4818-8421-1cf5858be01f" data-entity-substitution="canonical" title="Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development">Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development</a></td><td><a href="/media/165275/download?attachment" data-entity-type="media" data-entity-uuid="eb84c4b6-d714-437b-b8b8-ba2db47dbc95" data-entity-substitution="media_download" title="Neuro Studies Neonates Snapshot">Neonatal Neurodevelopmental Safety Studies Guidance Snapshot</a></td><td><a href="/media/165274/download?attachment" data-entity-type="media" data-entity-uuid="d13adaae-24bd-46ea-b7ab-bacb6879bc6b" data-entity-substitution="media_download" title="Neonatal Neurodevelopmental Safety Studies Podcast">Neonatal Neurodevelopmental Safety Studies Guidance Recap Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-considerations-long-term-clinical-neurodevelopmental-safety-studies-neonatal" data-entity-type="node" data-entity-uuid="e5133dd8-0aa8-498f-bd25-77c6698d1202" data-entity-substitution="canonical" title="Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development">Neonatal Neurodevelopmental Safety Studies Guidance Recap Podcast Transcript</a></td><td>Final</td><td>10/18/2024</td></tr><tr><td><a href="/regulatory-information/search-fda-guidance-documents/clinical-pharmacology-considerations-human-radiolabeled-mass-balance-studies" data-entity-type="node" data-entity-uuid="11548f09-acd8-47d4-a52e-05331a82e1b3" data-entity-substitution="canonical" title="Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies ">Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies</a></td><td><a href="/media/181634/download?attachment" data-entity-type="media" data-entity-uuid="d1fd4b4d-bf55-454f-a142-e02b380ea2cd" data-entity-substitution="media_download" title="Guidance Snapshot: Clinical Pharmacology Considerations For Human Radiolabeled Mass Balance Studies - Guidance for Industry">Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies: Guidance Snapshot</a></td><td><a href="/media/181635/download?attachment" data-entity-type="media" data-entity-uuid="3f6106c1-9125-4b5a-ab25-b3a0d39ce367" data-entity-substitution="media_download" title="Podcast for Human Radiolabeled Mass Balance Studies">Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies: Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-clinical-pharmacology-considerations-human-radiolabeled-mass-balance-studies" data-entity-type="node" data-entity-uuid="a907744f-0855-429f-b7f5-30800bcb62ac" data-entity-substitution="canonical" title="Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies">Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies: Podcast Transcript</a></td><td>Final</td><td>07/18/2024</td></tr><tr><td rowspan="2"><a href="/drugs/fdas-labeling-resources-human-prescription-drugs/patient-medication-information-pmi" data-entity-type="node" data-entity-uuid="00168454-e867-46b8-a50c-6a8057d066e8" data-entity-substitution="canonical" title="Patient Medication Information (PMI)">Medication Guide: Patient Medication</a><br><a href="/drugs/fdas-labeling-resources-human-prescription-drugs/patient-medication-information-pmi" data-entity-type="node" data-entity-uuid="00168454-e867-46b8-a50c-6a8057d066e8" data-entity-substitution="canonical" title="Patient Medication Information (PMI)">Information (PMI) Proposed Rule</a></td><td><a href="/media/180827/download?attachment" data-entity-type="media" data-entity-uuid="154317ed-e342-43a0-8b11-232b2b01ef1c" data-entity-substitution="media_download" title="PMI Industry Snapshot PDF">Patient Medication</a><br><a href="/media/180827/download?attachment" data-entity-type="media" data-entity-uuid="154317ed-e342-43a0-8b11-232b2b01ef1c" data-entity-substitution="media_download" title="PMI Industry Snapshot PDF">Information (PMI): Proposed Rule Snapshot</a></td><td><a href="/media/180825/download?attachment" data-entity-type="media" data-entity-uuid="23c3092f-f42f-4727-b725-e02dec7a9564" data-entity-substitution="media_download" title="Podcast for PMI Industry ">Patient Medication</a><br><a href="/media/180825/download?attachment" data-entity-type="media" data-entity-uuid="23c3092f-f42f-4727-b725-e02dec7a9564" data-entity-substitution="media_download" title="Podcast for PMI Industry ">Information (PMI): Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-patient-medication-information-pmi-proposed-rule" data-entity-type="node" data-entity-uuid="5d970a20-fb06-495b-b0a6-3cd634cd8194" data-entity-substitution="canonical" title="Guidance Recap Podcast | Patient Medication Information (PMI) Proposed Rule ">Patient Medication</a><br><a href="/drugs/guidances-drugs/guidance-recap-podcast-patient-medication-information-pmi-proposed-rule" data-entity-type="node" data-entity-uuid="5d970a20-fb06-495b-b0a6-3cd634cd8194" data-entity-substitution="canonical" title="Guidance Recap Podcast | Patient Medication Information (PMI) Proposed Rule ">Information (PMI): Podcast Transcript</a></td><td><a href="https://www.federalregister.gov/documents/2023/05/31/2023-11354/medication-guides-patient-medication-information">Proposed Rule</a></td><td>5/31/2023</td></tr><tr><td><a href="/media/180828/download?attachment" data-entity-type="media" data-entity-uuid="ea08535d-f1d0-4128-abf3-2b810af01344" data-entity-substitution="media_download" title="PMI Patient Snapshot PDF ">Patient Medication</a><br><a href="/media/180828/download?attachment" data-entity-type="media" data-entity-uuid="ea08535d-f1d0-4128-abf3-2b810af01344" data-entity-substitution="media_download" title="PMI Patient Snapshot PDF ">Information (PMI): Proposed Rule Snapshot for Patients</a></td><td><a href="/media/180826/download?attachment" data-entity-type="media" data-entity-uuid="f451782c-6d31-4861-858c-a82e9cdff191" data-entity-substitution="media_download" title="Podcast for PMI Patient">Patient Medication</a><br><a href="/media/180826/download?attachment" data-entity-type="media" data-entity-uuid="f451782c-6d31-4861-858c-a82e9cdff191" data-entity-substitution="media_download" title="Podcast for PMI Patient">Information (PMI): Podcast for Patients</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-podcast-patients-patient-medication-information-pmi-proposed-rule" data-entity-type="node" data-entity-uuid="752266fd-3def-43ea-a96d-140d9f62170d" data-entity-substitution="canonical" title="Guidance Recap Podcast | Podcast for Patients on Patient Medication Information (PMI) Proposed Rule ">Patient Medication</a><br><a href="/drugs/guidances-drugs/guidance-recap-podcast-podcast-patients-patient-medication-information-pmi-proposed-rule" data-entity-type="node" data-entity-uuid="752266fd-3def-43ea-a96d-140d9f62170d" data-entity-substitution="canonical" title="Guidance Recap Podcast | Podcast for Patients on Patient Medication Information (PMI) Proposed Rule ">Information (PMI): Podcast Transcript for Patients</a></td><td><a href="https://www.federalregister.gov/documents/2023/05/31/2023-11354/medication-guides-patient-medication-information">Proposed Rule</a></td><td>5/31/2023</td></tr><tr><td><a href="/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations" data-entity-type="node" data-entity-uuid="e145ad98-149e-4576-9796-0ebc86e6de57" data-entity-substitution="canonical" title="Digital Health Technologies for Remote Data Acquisition in Clinical Investigations">Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: Guidance Document</a></td><td><a href="/media/180193/download?attachment" data-entity-type="media" data-entity-uuid="af1fd998-5180-4705-b2b6-58062ce4d88c" data-entity-substitution="media_download" title="Guidance Snapshot: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations">Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: Guidance Snapshot</a></td><td><a href="/media/180060/download?attachment" data-entity-type="media" data-entity-uuid="1bcf2558-c6b1-4749-a0ab-3f97415e13ed" data-entity-substitution="media_download" title="Podcast for DHT Final">Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: Podcast</a></td><td><a href="/about-fda/page-not-found" data-entity-type="node" data-entity-uuid="0866c02a-ecca-415f-a707-1fa2f4477679" 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href="/media/180044/download?attachment" data-entity-type="media" data-entity-uuid="0e068257-ad6e-49b5-86f7-d151ef841d73" data-entity-substitution="media_download" title="Podcast for Oligonucleotide ">Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics: Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-clinical-pharmacology-considerations-development-oligonucleotide-therapeutics" data-entity-type="node" data-entity-uuid="7809c8a9-2084-4f5b-8590-3dd434e18c2b" data-entity-substitution="canonical" title="Guidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics">Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics: Podcast Transcript</a></td><td>Final</td><td>06/14/2024</td></tr><tr><td><a 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data-entity-substitution="media_download" title="Podcast for E19 Final">E19 A Selective Approach to Safety Data Collection: Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-e19-selective-approach-safety-data-collection-specific-late-stage-pre" data-entity-type="node" data-entity-uuid="b8b93b03-5bb3-4fc1-8ccc-55f38e325fe8" data-entity-substitution="canonical" title="Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials">E19 A Selective Approach to Safety Data Collection: Podcast Transcript</a></td><td>Final</td><td>12/05/2022</td></tr><tr><td><a href="/regulatory-information/search-fda-guidance-documents/pharmacokinetics-patients-impaired-renal-function-study-design-data-analysis-and-impact-dosing" data-entity-type="node" data-entity-uuid="f3b1fe96-efd4-441d-afa9-4c5d9f2d313c" data-entity-substitution="canonical" title="Pharmacokinetics in Patients with Impaired Renal 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href="/drugs/guidances-drugs/guidance-recap-podcast-master-protocols-drug-and-biological-product-development" data-entity-type="node" data-entity-uuid="62e1d350-643c-42d1-859f-388b066fb8db" data-entity-substitution="canonical" title="Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development">Master Protocols: Transcript</a></td><td>Draft</td><td>12/22/2023</td></tr><tr><td><a href="/regulatory-information/search-fda-guidance-documents/drug-drug-interaction-assessment-therapeutic-proteins-guidance-industry" data-entity-type="node" data-entity-uuid="8fd75402-e7e3-40f6-b813-6a4686a430ca" data-entity-substitution="canonical" title="Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry">Drug-Drug Interaction Assessment for Therapeutic Proteins</a></td><td><a href="/media/174606/download?attachment" data-entity-type="media" data-entity-uuid="f7d8f816-887b-4850-9b68-18a10972a5d0" data-entity-substitution="media_download" title="Guidance Snapshot OTS Therapeutic.Protein">Drug-Drug Interaction Assessment for Therapeutic Proteins - Guidance Snapshot</a> </td><td><a href="/media/174593/download?attachment" data-entity-type="media" data-entity-uuid="58cef1b0-aaa4-440c-a864-7995c4f153ff" data-entity-substitution="media_download" title="Podcast: Drug-Drug Interaction Assessment for Therapeutic Proteins">Drug-Drug Interaction Assessment for Therapeutic Proteins: Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-drug-drug-interaction-assessment-therapeutic-proteins" data-entity-type="node" data-entity-uuid="59ce3e2b-9dca-42f6-a7d7-b98cc98a992d" data-entity-substitution="canonical" title="Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins">Drug-Drug Interaction Assessment for Therapeutic Proteins: Podcast Transcript</a></td><td>Final</td><td>6/22/2023</td></tr><tr><td><a 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Study Reports Qand A">Translation of Good Laboratory Practice Study Reports: Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-translation-good-laboratory-practice-study-reports-questions-and-answers" data-entity-type="node" data-entity-uuid="088a9a4b-4590-4da6-aae5-06530b6f4d0f" data-entity-substitution="canonical" title="Guidance Recap Podcast | Translation of Good Laboratory Practice Study Reports: Questions and Answers ">Translation of Good Laboratory Practice Study Reports: Podcast Transcript</a></td><td>Draft</td><td>11/21/2023</td></tr><tr><td><a href="/regulatory-information/search-fda-guidance-documents/benefit-risk-assessment-new-drug-and-biological-products" data-entity-type="node" data-entity-uuid="c60bd108-c077-4d58-9e2b-3431470d1421" data-entity-substitution="canonical" title="Benefit-Risk Assessment for New Drug and Biological Products">Benefit-Risk Assessment for New Drug and Biologic Products</a></td><td><a href="/media/152506/download?attachment" data-entity-type="media" data-entity-uuid="ef12924d-9da9-4db6-8ad4-07415ac7918b" data-entity-substitution="media_download" title="Benefit-Risk Assessment for New Drug and Biologic Products Snapshot">Benefit-Risk Assessment for New Drug and Biologic Products Snapshot</a></td><td><a href="/media/152507/download?attachment" data-entity-type="media" data-entity-uuid="3e3c1ec2-d475-4db6-9086-74484c2514e7" data-entity-substitution="media_download" title="Benefit-Risk Assessment for New Drug and Biologic Products Podcast">Benefit-Risk Assessment for New Drug and Biologic Products Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-benefit-risk-assessment-new-drug-and-biologic-products" data-entity-type="node" data-entity-uuid="307d9dd6-6a3b-4191-968e-76037f984b39" data-entity-substitution="canonical" title="Guidance Recap Podcast | Benefit-Risk Assessment for New Drug and Biologic Products">Benefit-Risk Assessment for New Drug 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Snapshot</a></td><td><a href="/media/168512/download?attachment" data-entity-type="media" data-entity-uuid="0a603f43-e891-4408-901d-0ef4d8e56c4a" data-entity-substitution="media_download" title="Adjusting for Covariates Final Guidance Podcast">Adjusting Covariates -</a><br><a href="/media/168512/download?attachment" data-entity-type="media" data-entity-uuid="0a603f43-e891-4408-901d-0ef4d8e56c4a" data-entity-substitution="media_download" title="Adjusting for Covariates Final Guidance Podcast">Guidance Recap Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-adjusting-covariates-randomized-clinical-trials-drugs-and-biological-products" data-entity-type="node" data-entity-uuid="8d23b78c-f287-4fb7-a54f-ac47c2a7a93b" data-entity-substitution="canonical" title="Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products">Adjusting Covariates -</a><br><a href="/drugs/guidances-drugs/guidance-recap-podcast-adjusting-covariates-randomized-clinical-trials-drugs-and-biological-products" data-entity-type="node" data-entity-uuid="8d23b78c-f287-4fb7-a54f-ac47c2a7a93b" data-entity-substitution="canonical" title="Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products">Guidance Recap Podcast Transcript</a></td><td>Final</td><td>5/26/2023</td></tr><tr><td><a href="/regulatory-information/search-fda-guidance-documents/use-whole-slide-imaging-nonclinical-toxicology-studies-questions-and-answers" data-entity-type="node" data-entity-uuid="d673a30b-a2de-462e-a7f9-e2fa477067ad" data-entity-substitution="canonical" title="Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers">Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers</a></td><td><a href="/media/168471/download?attachment" data-entity-type="media" data-entity-uuid="11d881fa-48a5-48ee-a0e5-73fb448d155e" data-entity-substitution="media_download" title="Guidance Snapshot - Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers">Whole Slide Imaging -Guidance Snapshot</a></td><td><a href="/media/168477/download?attachment" data-entity-type="media" data-entity-uuid="7e9cf3b9-56d1-482f-89d7-c4c70d129839" data-entity-substitution="media_download" title="Whole Slide Imaging -Guidance Recap Podcast">Whole Slide Imaging -Guidance Recap Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-use-whole-slide-imaging-nonclinical-toxicology-studies-questions-and-answers" data-entity-type="node" data-entity-uuid="0b328661-4418-460e-bcbb-b00315c6e8e1" data-entity-substitution="canonical" title="Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers">Whole Slide Imaging -Guidance Recap Podcast Transcript</a></td><td>Final</td><td>5/25/2023</td></tr><tr><td><a href="/regulatory-information/search-fda-guidance-documents/evaluation-gastric-ph-dependent-drug-interactions-acid-reducing-agents-study-design-data-analysis" data-entity-type="node" data-entity-uuid="bd1b3791-55f9-45a8-81bb-4f62ad77acc1" data-entity-substitution="canonical" title="Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry">Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications</a></td><td><a href="/media/168141/download?attachment" data-entity-type="media" data-entity-uuid="f0cd5017-7e86-408a-9f86-e70f99dfad20" data-entity-substitution="media_download" title="OTS GastricpH Snapshot">Evaluation of Gastric pH Dependent DDIs -Guidance Snapshot</a></td><td><a href="/media/168140/download?attachment" data-entity-type="media" data-entity-uuid="4a1bc6df-e6d4-45e5-b6be-a50e93690a85" data-entity-substitution="media_download" title="Gastric PH Podcast">Evaluation of Gastric pH Dependent DDIs -Guidance Recap Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-evaluation-gastric-ph-dependent-drug-interactions-acid-reducing-agents-study" data-entity-type="node" data-entity-uuid="db711d26-594e-4925-b797-1d6ea828bc1f" data-entity-substitution="canonical" title="Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications">Evaluation of Gastric pH Dependent DDIs -Guidance Recap Podcast Transcript</a></td><td>Final</td><td>3/10/2023</td></tr><tr><td><a href="/regulatory-information/search-fda-guidance-documents/multiple-endpoints-clinical-trials" data-entity-type="node" data-entity-uuid="bdc0817d-cd4a-4ed2-a3f4-23ca1eb045cd" data-entity-substitution="canonical" title="Multiple Endpoints in Clinical Trials">Multiple Endpoints in Clinical Trials</a></td><td><a href="/media/162427/download?attachment" data-entity-type="media" data-entity-uuid="80382905-9431-40e8-9294-ac196a4d2186" data-entity-substitution="media_download" title="Multiple Endpoints Snapshot Podcast">Multiple Endpoints Guidance Snapshot</a></td><td><a href="/media/162425/download?attachment" data-entity-type="media" data-entity-uuid="efc90867-dd2c-4e2a-8e09-6803d9f87374" data-entity-substitution="media_download" title="Multiple Endpoints Podcast 2022">Multiple Endpoints Guidance Recap Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-multiple-endpoints-clinical-trials" data-entity-type="node" data-entity-uuid="641888e9-15aa-4967-925a-926fa9300f2c" data-entity-substitution="canonical" title="Guidance Recap Podcast | Multiple Endpoints in Clinical Trials">Multiple Endpoints Guidance Recap Podcast Transcript</a></td><td>Final</td><td>10/21/2022</td></tr><tr><td><a href="/regulatory-information/search-fda-guidance-documents/ethical-considerations-clinical-investigations-medical-products-involving-children" data-entity-type="node" data-entity-uuid="aee76f42-0491-4df7-9840-1f664392dbc5" data-entity-substitution="canonical" title="Ethical Considerations for Clinical Investigations of Medical Products Involving Children">Ethical Considerations for Clinical Investigations of Medical Products Involving Children</a></td><td><a href="/media/161749/download?attachment" data-entity-type="media" data-entity-uuid="52fa92d1-2a1e-4c27-8f15-9b5d0678e2a6" data-entity-substitution="media_download" title="Ethical Considerations for Clinical Investigations Involving Children - Guidance Snapshot">Ethical Considerations for Clinical Investigations Involving Children -Guidance Snapshot</a></td><td><a href="/media/161781/download?attachment" data-entity-type="media" data-entity-uuid="de03aabf-1c12-4a80-a567-80a0d3fd9701" data-entity-substitution="media_download" title="Guidance Recap Podcast | Ethical Considerations for Clinical Investigations of Medical Products Involving Children">Ethical Considerations for Clinical Investigations Involving Children -Guidance Recap Podcast</a> </td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-ethical-considerations-clinical-investigations-medical-products-involving" data-entity-type="node" data-entity-uuid="479f9c03-34c9-4c49-8f43-29e64edb6523" data-entity-substitution="canonical" title="Guidance Recap Podcast | Ethical Considerations for Clinical Investigations of Medical Products Involving Children">Ethical Considerations for Clinical Investigations Involving Children -Guidance Recap Podcast Transcript</a></td><td>Draft</td><td>9/26/2022</td></tr><tr><td><a href="/media/129532/download?attachment" data-entity-type="media" data-entity-uuid="844bf16f-d327-40e9-932b-e3ab812ee8ef" data-entity-substitution="media_download" title="NeonatalClinPharm_pdf">General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products</a></td><td><a href="/media/160256/download?attachment" data-entity-type="media" data-entity-uuid="72e263dd-5cb0-47bd-9893-c02e36f037d6" data-entity-substitution="media_download" title="OTS Neonatal Snapshot">Neonatal Guidance Snapshot</a></td><td><a href="/media/160255/download?attachment" data-entity-type="media" data-entity-uuid="970d1063-721d-40e0-98eb-4b5ee21a0204" data-entity-substitution="media_download" title="Neonatal Podcast 2022">Neonatal Guidance Recap Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-general-clinical-pharmacology-considerations-neonatal-studies-drugs-and" data-entity-type="node" data-entity-uuid="beff12e9-4623-47bc-82df-9ee6f3c2eca8" data-entity-substitution="canonical" title="Guidance Recap Podcast | General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products ">Neonatal Guidance Recap Podcast Transcript</a></td><td>Final</td><td>7/27/2022</td></tr><tr><td><a href="/regulatory-information/search-fda-guidance-documents/patient-focused-drug-development-selecting-developing-or-modifying-fit-purpose-clinical-outcome" data-entity-type="node" data-entity-uuid="76336ad1-86aa-490d-b40c-8c580cba71ac" data-entity-substitution="canonical" title="Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments">Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments</a></td><td><a href="/media/159516/download?attachment" data-entity-type="media" data-entity-uuid="7e085a0f-410c-4dae-89c4-1efda1d4f831" data-entity-substitution="media_download" title="PFDD COA Guidance Snapshot">PFDD COA</a><br><a href="/media/159516/download?attachment" data-entity-type="media" data-entity-uuid="7e085a0f-410c-4dae-89c4-1efda1d4f831" data-entity-substitution="media_download" title="PFDD COA Guidance Snapshot">Guidance</a><br><a href="/media/159516/download?attachment" data-entity-type="media" data-entity-uuid="7e085a0f-410c-4dae-89c4-1efda1d4f831" data-entity-substitution="media_download" title="PFDD COA Guidance Snapshot">Snapshot</a></td><td><a href="/media/159508/download?attachment" data-entity-type="media" data-entity-uuid="254bec51-43b3-4286-a6fb-99bbe7ba76e5" data-entity-substitution="media_download" title="Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments Podcast">PFDD COA</a><br><a href="/media/159508/download?attachment" data-entity-type="media" data-entity-uuid="254bec51-43b3-4286-a6fb-99bbe7ba76e5" data-entity-substitution="media_download" title="Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments Podcast">Guidance Recap</a><br><a href="/media/159508/download?attachment" data-entity-type="media" data-entity-uuid="254bec51-43b3-4286-a6fb-99bbe7ba76e5" data-entity-substitution="media_download" title="Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments Podcast">Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-selecting-developing-or-modifying-fit-purpose-clinical-outcomes-assessments" data-entity-type="node" data-entity-uuid="fba071d4-8700-4776-b0b4-efb306d22724" data-entity-substitution="canonical" title="Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments">PFDD COA</a><br><a href="/drugs/guidances-drugs/guidance-recap-podcast-selecting-developing-or-modifying-fit-purpose-clinical-outcomes-assessments" data-entity-type="node" data-entity-uuid="fba071d4-8700-4776-b0b4-efb306d22724" data-entity-substitution="canonical" title="Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments">Guidance Recap</a><br><a href="/drugs/guidances-drugs/guidance-recap-podcast-selecting-developing-or-modifying-fit-purpose-clinical-outcomes-assessments" data-entity-type="node" data-entity-uuid="fba071d4-8700-4776-b0b4-efb306d22724" data-entity-substitution="canonical" title="Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments">Podcast Transcript</a></td><td>Draft</td><td>6/30/2022</td></tr><tr><td><a href="/regulatory-information/search-fda-guidance-documents/assessing-effects-food-drugs-inds-and-ndas-clinical-pharmacology-considerations" data-entity-type="node" data-entity-uuid="a381152e-570b-4557-91b1-e2faecb66527" data-entity-substitution="canonical" title="Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations">Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations</a></td><td><a href="/media/159416/download?attachment" data-entity-type="media" data-entity-uuid="e7ee4db3-91d5-41d0-851f-9b36f8bf53b4" data-entity-substitution="media_download" title="Food Effects Guidance Snapshot">Food Effects Guidance Snapshot</a></td><td><a href="/media/159415/download?attachment" data-entity-type="media" data-entity-uuid="b429f359-9a97-483c-b4d7-cb2c0cbfedfc" data-entity-substitution="media_download" title="Guidance Recap Podcast: Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations">Food Effects Guidance Recap Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-assessing-effects-food-drugs-inds-and-ndas-clinical-pharmacology" data-entity-type="node" data-entity-uuid="0a9a9205-e76f-4730-8903-7b38a8168570" data-entity-substitution="canonical" title="Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations">Food Effects Guidance Recap Podcast Transcript</a></td><td>Final</td><td>6/24/2022</td></tr><tr><td><a href="/regulatory-information/search-fda-guidance-documents/bioavailability-studies-submitted-ndas-or-inds-general-considerations" data-entity-type="node" data-entity-uuid="268068b2-8d73-4da2-a085-5cdf4878c9e4" data-entity-substitution="canonical" title="Bioavailability Studies Submitted in NDAs or INDs – General Considerations">Bioavailability Studies Submitted in NDAs or INDs – General Considerations</a></td><td><a href="/media/157685/download?attachment" data-entity-type="media" data-entity-uuid="fb23c93f-de04-4a17-84c3-73bd1b4d8139" data-entity-substitution="media_download" title="Guidance Snapshot Bioavailability Studies Submitted in NDAs or INDs – General Considerations ">Bioavailability Guidance Snapshot</a></td><td><a href="/media/157677/download?attachment" data-entity-type="media" data-entity-uuid="90bc6e07-6e71-4171-810a-ec50ce4c7b40" data-entity-substitution="media_download" title="Guidance Recap Podcast: Bioavailability Studies Submitted in NDAs or INDs – General Considerations">Bioavailability Guidance Recap Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-bioavailability-studies-submitted-ndas-or-inds-general-considerations" data-entity-type="node" data-entity-uuid="cf0ff5a1-bff0-4fb7-8f72-13bc32c1ec92" data-entity-substitution="canonical" title="Guidance Recap Podcast | Bioavailability Studies Submitted in NDAs or INDs – General Considerations">Bioavailability Guidance Recap Podcast Transcript</a></td><td>Final</td><td>4/15/2022</td></tr><tr><td><a href="/regulatory-information/search-fda-guidance-documents/population-pharmacokinetics" data-entity-type="node" data-entity-uuid="1dd1f94b-5388-4c76-aa2f-00d516e6504a" data-entity-substitution="canonical" title="Population Pharmacokinetics">Population Pharmacokinetics</a></td><td><a href="/media/155925/download?attachment" data-entity-type="media" data-entity-uuid="859aca1a-5922-480f-9d81-55436a4eed97" data-entity-substitution="media_download" title="OTS Population PK Snapshot Final">Population Pharmacokinetics Guidance Snapshot</a></td><td><a href="/media/155926/download?attachment" data-entity-type="media" data-entity-uuid="6d0c0bba-589a-48e9-b745-bf7ec2d77f5d" data-entity-substitution="media_download" title="Pop PK Podcast">Population Pharmacokinetics Guidance Recap Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-population-pharmacokinetics" data-entity-type="node" data-entity-uuid="c9e9e297-5004-41a9-91c1-65668b69de8d" data-entity-substitution="canonical" title="Guidance Recap Podcast | Population Pharmacokinetics">Population Pharmacokinetics Guidance Recap Podcast Transcript</a></td><td>Final</td><td>2/3/2022</td></tr><tr><td><a href="/regulatory-information/search-fda-guidance-documents/pathology-peer-review-nonclinical-toxicology-studies-questions-and-answers">Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers</a></td><td><a href="/media/155164/download?attachment" data-entity-type="media" data-entity-uuid="ca0cb0fe-8778-4089-bc08-ae4719b49e3f" data-entity-substitution="media_download" title="OTS_PathologyPeerReview_Snapshot_final_pdf">Pathology Peer Review Guidance Snapshot</a></td><td><a href="/media/155165/download?attachment" data-entity-type="media" data-entity-uuid="5edd99a3-d1ba-4d64-b1a8-554a238fec78" data-entity-substitution="media_download" title="PPR Podcast_mp3">Pathology Peer Review Guidance Recap Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-pathology-peer-review-nonclinical-toxicology-studies-questions-and-answers" data-entity-type="node" data-entity-uuid="8d15343d-081c-4a44-8ecd-79178b491299" data-entity-substitution="canonical" title="Guidance Recap Podcast | Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers">Pathology Peer Review Guidance Recap Podcast Transcript</a></td><td>Final</td><td>12/27/2021</td></tr><tr><td><a href="/drugs/guidances-drugs/product-specific-guidances-generic-drug-development" data-entity-type="node" data-entity-uuid="b6e6a8fd-93a9-47ff-bb35-5ed4a7c22df0" data-entity-substitution="canonical" title="Product-Specific Guidances for Generic Drug Development">Product-Specific Guidances for Generic Drug Development</a></td><td><a href="/media/150142/download?attachment" data-entity-type="media" data-entity-uuid="f6e56db6-595f-4712-8cd2-1ea6b28b44ee" data-entity-substitution="media_download" title="FDA Product Specific Guidance Snapshot Cover">Product-Specific Guidance Snapshot</a></td><td> </td><td> </td><td>Multiple</td><td>Multiple</td></tr><tr><td><a href="/about-fda/page-not-found" data-entity-type="node" data-entity-uuid="98483a5f-2f28-48fd-832a-74d5d9b5af1e" data-entity-substitution="canonical">In Vitro Drug Interaction Studies - Cytochrome P450 Enzyme-and Transporter-Mediated Drug Interactions Final Guidance</a></td><td><a href="/media/135587/download?attachment" data-entity-type="media" data-entity-uuid="57a6e141-297c-48e6-b181-45140127b3ed" data-entity-substitution="media_download" title="OTS_ExternalInVitroDDISnapshot_FINAL_508">In Vitro DDI Guidance Snapshot</a></td><td><a href="/media/135491/download?attachment" data-entity-type="media" data-entity-uuid="ee8590bc-544b-4976-94eb-42ac204ab7e4" data-entity-substitution="media_download" title="In Vitro DDI Podcast">In Vitro DDI Guidance Recap Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-in-vitro-drug-interaction-studies-cytochrome-p450-enzyme-and-transporter" data-entity-type="node" data-entity-uuid="e157844e-6c7b-499f-aa5b-ad7cc754fe72" data-entity-substitution="canonical" title="Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance">In Vitro DDI Guidance Recap Podcast Transcript</a></td><td>Final</td><td>01/23/2020</td></tr><tr><td><a href="/about-fda/page-not-found" data-entity-type="node" data-entity-uuid="a15b1b13-7d99-4f97-873a-66cc6c9988da" data-entity-substitution="canonical">Clinical Drug Interaction Studies - Cytochrome P450 Enzyme-and Transporter-Mediated Drug Interactions Final Guidance</a></td><td><a href="/media/135586/download?attachment" data-entity-type="media" data-entity-uuid="bfaf7513-4470-4759-96d1-904b619f10c5" data-entity-substitution="media_download" title="OTS_ExternalClinicalDDISnapshot_200225_1235pm Final 508">Clinical DDI Guidance Snapshot</a></td><td><a href="/media/135490/download?attachment" data-entity-type="media" data-entity-uuid="ac0faf7b-e34c-4af8-9a14-5fb7fcea655b" data-entity-substitution="media_download" title="Clinical DDI Podcast">Clinical DDI Guidance Recap Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-clinical-drug-interaction-studies-cytochrome-p450-enzyme-and-transporter" data-entity-type="node" data-entity-uuid="d102eac9-0856-4be3-8caf-3fda9bdf6f1a" data-entity-substitution="canonical" title="Guidance Recap Podcast | Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance">Clinical DDI Guidance Recap Podcast Transcript</a></td><td>Final</td><td>01/23/2020</td></tr><tr><td><a href="/regulatory-information/search-fda-guidance-documents/interacting-fda-complex-innovative-trial-designs-drugs-and-biological-products" data-entity-type="node" data-entity-uuid="0445e1e2-4316-446a-8a0a-f22ae47bcd63" data-entity-substitution="canonical" title="Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products">Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products</a></td><td><a href="/media/140756/download?attachment" data-entity-type="media" data-entity-uuid="dc750cae-0bb8-473c-a13d-4468e24a935e" data-entity-substitution="media_download" title="Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products Snapshot">CID Snapshot</a></td><td><a href="/media/140755/download?attachment" data-entity-type="media" data-entity-uuid="04ca1aed-bf87-40bc-be8e-45a7ff2b9028" data-entity-substitution="media_download" title="Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products">CID Guidance Recap Podcast</a></td><td><a href="/drugs/guidances-drugs/guidance-recap-podcast-interacting-fda-complex-innovative-trial-designs-drugs-and-biological" data-entity-type="node" data-entity-uuid="27678318-89b5-4d25-b9a5-36a799c78988" data-entity-substitution="canonical" title="Guidance Recap Podcast | Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products Podcast">CID Guidance Recap Podcast Transcript</a></td><td>Final</td><td>12/16/2020</td></tr><tr><td><a href="/media/125080/download">Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The -Counter Monograph: Study Elements and Considerations Final Guidance</a></td><td><a href="/media/140321/download?attachment" data-entity-type="media" data-entity-uuid="d104c204-cbee-45c9-8576-8d726fef8195" data-entity-substitution="media_download" title="MUsT_Infographic_2000626_1602FINAL_pdf">MUsT Snapshot</a></td><td> </td><td> </td><td>Final</td><td>05/10/2019</td></tr><tr><td><a href="/media/117173/download?attachment" data-entity-type="media" data-entity-uuid="5922ae5b-8c6c-4d03-8b11-b33f1dcf8c1e" data-entity-substitution="media_download" title="Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease">Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease Final Guidance</a></td><td><a href="/media/135588/download?attachment" data-entity-type="media" data-entity-uuid="d80b3130-4131-4e59-b110-a959248af0a2" data-entity-substitution="media_download" title="OTS External Targeted Therapies Snapshot">Targeted Therapies Guidance Snapshot</a></td><td> </td><td> </td><td>Final</td><td>10/16/2018</td></tr></tbody></table></div>   </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 class="lcds-description-list__item-text"><time datetime="2024-10-16T00:00:00Z">10/16/2024</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Regulated Product(s)</h2> <ul role="menu" class="lcds-metadata-list"> <li role="menuitem">Drugs</li> </ul> </div> </li> </ul> </aside> </div> </section> </aside> <aside class="col-md-2 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