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    Government

    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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    Latest Episodes:
    Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations Jul 07, 2026
    Show notes

    Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations


    Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development Jun 22, 2026
    Show notes

    Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development


    Guidance Recap Podcast | Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products Mar 25, 2026
    Show notes

    Guidance Recap Podcast | Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products


    Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments Oct 22, 2025
    Show notes

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


    Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development Oct 16, 2024
    Show notes

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


    Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies Sep 18, 2024
    Show notes

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


    Guidance Recap Podcast | Patient Medication Information (PMI) Proposed Rule Sep 09, 2024
    Show notes

    Guidance Recap Podcast | Patient Medication Information (PMI) Proposed Rule


    Guidance Recap Podcast | Podcast for Patients on Patient Medication Information (PMI) Proposed Rule Sep 09, 2024
    Show notes

    Guidance Recap Podcast | Podcast for Patients on Patient Medication Information (PMI) Proposed Rule


    Guidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Jul 24, 2024
    Show notes

    Guidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations


    Guidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Jul 15, 2024
    Show notes

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


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