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27 episodes
Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development
06/22/2026 | 14 mins.Guidance Recap Podcast | Master Protocols for Drug and Biological Product DevelopmentGuidance Recap Podcast | Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products
03/25/2026 | 13 mins.Guidance Recap Podcast | Use of Bayesian Methodology in Clinical Trials of Drug and Biological ProductsGuidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments
10/22/2025 | 8 mins.Guidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes AssessmentsGuidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
10/16/2024 | 12 mins.Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product DevelopmentGuidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
09/18/2024 | 18 mins.Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
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About FDA Guidance Recap Podcast
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.
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FDA Guidance Recap Podcast
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