The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors. Through conversations with FDA staff, this podcast is inten... More
The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors. Through conversations with FDA staff, this podcast is inten... More
Available Episodes
5 of 18
Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
25/05/2023
7:34
Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
24/05/2023
11:22
Guidance Recap Podcast | Podcast for Patients — 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—Podcast for Patients
19/05/2023
14:14
Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications
Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications
15/05/2023
12:45
Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
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.