FDA Guidance Recap Podcast

By U.S. Food and Drug Administration

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Subscribers: 1
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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
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
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
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
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
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
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
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
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
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
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
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
Guidance Recap Podcast: Bioavailability Studies Submitted in NDAs or INDs – General Considerations
Apr 14, 2022
Guidance Recap Podcast | Population Pharmacokinetics
6:24
Guidance Recap Podcast: Population Pharmacokinetics
Feb 04, 2022
Guidance Recap Podcast | Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers
12:20
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
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
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
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
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
Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript
Feb 28, 2020