PodcastsGobiernoFDA Guidance Recap Podcast

FDA Guidance Recap Podcast

U.S. Food and Drug Administration
FDA Guidance Recap Podcast
Último episodio

25 episodios

  • FDA Guidance Recap Podcast

    Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments

    22/10/2025 | 8 min
    Guidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments
  • FDA Guidance Recap Podcast

    Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development

    16/10/2024 | 12 min
    Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
  • FDA Guidance Recap Podcast

    Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies

    18/9/2024 | 18 min
    Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
  • FDA Guidance Recap Podcast

    Guidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics

    15/7/2024 | 14 min
    Guidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
  • FDA Guidance Recap Podcast

    Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials

    22/4/2024 | 12 min
    Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials

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Acerca de 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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