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FDA Guidance Recap Podcast

By U.S. Food and Drug Administration

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Category: Government

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Episodes: 19

Description

The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors. Through conversations with FDA staff, this podcast is intended help communicate salient key points and background information about a subset of cross-cutting guidance documents on topics that seek to modernize and accelerate drug development.

Episode	Date
Guidance Recap Podcast \| Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products 7:34 http://www.fda.gov/files/drugs/published/AdjustingforCovariates-Podcast-Final-Guidance.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 94700897743 20230525-141205 Guidance Recap Podcast \| Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products	May 25, 2023
Guidance Recap Podcast \| Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers 11:22 http://www.fda.gov/files/drugs/published/WSI-Podcast.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 94698914536 20230524-173323 Guidance Recap Podcast \| Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers	May 24, 2023
Guidance Recap Podcast \| Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs http://www.fda.gov/drugs/guidances-drugs/guidance-recap-podcast-enhancing-diversity-clinical-trial-populations-eligibility-criteria https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 94693641025 20230522-162245 Guidance Recap Podcast \| Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs	May 22, 2023
Guidance Recap Podcast \| Podcast for Patients — Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs 14:14 http://www.fda.gov/files/drugs/published/Enhancing%20Diversity%20Industry%20Podcast_0.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 94693641026 20230522-162418 Guidance Recap Podcast \| Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs—Podcast for Patients	May 19, 2023
Guidance Recap Podcast \| Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications 12:45 http://www.fda.gov/files/drugs/published/Gastric-pH-Podcast_0.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 94680302053 20230515-141440 Guidance Recap Podcast \| Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications	May 15, 2023
Guidance Recap Podcast \| Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development 12:17 http://www.fda.gov/files/drugs/published/Neonatal-Neurodevelopmental-Safety-Studies-Podcast.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 86303202645 20230209-154653 Guidance Recap Podcast \| Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development	Feb 10, 2023
Guidance Recap Podcast \| Multiple Endpoints in Clinical Trials 11:49 http://www.fda.gov/files/drugs/published/Multiple%20Endpoints%20Podcast-2022.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 73126238326 20221019-171449 Guidance Recap Podcast \| Multiple Endpoints in Clinical Trials	Oct 20, 2022
Guidance Recap Podcast \| Ethical Considerations for Clinical Investigations of Medical Products Involving Children 14:52 http://www.fda.gov/files/drugs/published/Pediatric%20Ethical%20Considerations%20Podcast%202022.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 70787149839 20220922-171643 Thoughts on newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”	Sep 23, 2022
Guidance Recap Podcast \| General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products 8:41 http://www.fda.gov/files/drugs/published/Neonatal%20Podcast%202022.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 70787149840 20220726-143333 Guidance Recap Podcast: General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products	Jul 26, 2022
Guidance Recap Podcast \| Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments 11:29 http://www.fda.gov/files/drugs/published/G3%20Podcast.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 70787149841 20220629-103842 Guidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments	Jun 29, 2022
Guidance Recap Podcast \| Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations 8:51 http://www.fda.gov/files/drugs/published/Food%20Effects%20Podcast.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 70787149842 20220624-125733 Guidance Recap Podcast \| Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations	Jun 24, 2022
Guidance Recap Podcast \| Bioavailability Studies Submitted in NDAs or INDs – General Considerations 8:02 http://www.fda.gov/files/drugs/published/BA%20Podcast.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 70787149843 20220413-163239 Guidance Recap Podcast: Bioavailability Studies Submitted in NDAs or INDs – General Considerations	Apr 14, 2022
Guidance Recap Podcast \| Population Pharmacokinetics 6:24 http://www.fda.gov/files/drugs/published/Pop%20PK%20Podcast.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 70787149844 20220204-084529 Guidance Recap Podcast: Population Pharmacokinetics	Feb 04, 2022
Guidance Recap Podcast \| Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers 12:20 http://www.fda.gov/files/drugs/published/PPR%20Podcast.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 70787149845 20211230-111718 Recap Podcast: Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers	Dec 27, 2021
Guidance Recap Podcast \| Benefit-Risk Assessment for New Drug and Biologic Products 13:06 http://www.fda.gov/files/drugs/published/09-24-21-72-31-25-BR%20Podcast.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 70787149846 20210929-111550 Guidance Recap Podcast: Benefit-Risk Assessment for New Drug and Biologic Products	Sep 29, 2021
Guidance Recap Podcast \| Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics 6:59 http://www.fda.gov/files/drugs/published/AdjustingCovariatePodcast.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 70787149847 20210521-101854 Dr. Dan Rubin, statistician, Division of Biometrics IV in CDER’s Office of Biostatistics sharing some thoughts draft guidance Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics	May 21, 2021
Guidance Recap Podcast \| Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products Podcast 11:33 http://www.fda.gov/files/Interview%20with%20Dr%20Levin%20v2.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 70787149848 20200803-154839 The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors.	Dec 15, 2020
Guidance Recap Podcast \| Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance 6:54 http://www.fda.gov/files/drugs/published/Clinical%20DDI%20Podcast.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 70787149850 20200228-083252 Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript	Feb 28, 2020
Guidance Recap Podcast \| In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance 14:05 http://www.fda.gov/files/drugs/published/In%20Vitro%20DDI%20podcast.mp3 https://www.fda.gov/files/OTS_GuidanceRecapPodcast_210608.png 70787149849 20200228-083355 Guidance Recap Podcast \| In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript	Feb 28, 2020

FDA Guidance Recap Podcast

By U.S. Food and Drug Administration

Category: Government

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Description