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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 | Ethical Considerations for Clinical Investigations of Medical Products Involving Children Sep 23, 2022
    Show notes

    Thoughts on newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”

    Guidance Recap Podcast | General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Jul 26, 2022
    Show notes

    Guidance Recap Podcast: General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products

    Guidance Recap Podcast | Bioavailability Studies Submitted in NDAs or INDs – General Considerations Apr 14, 2022
    Show notes

    Guidance Recap Podcast: Bioavailability Studies Submitted in NDAs or INDs – General Considerations

    Guidance Recap Podcast | Population Pharmacokinetics Feb 04, 2022
    Show notes

    Guidance Recap Podcast: Population Pharmacokinetics

    Guidance Recap Podcast | Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers Dec 27, 2021
    Show notes

    Recap Podcast: Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers

    Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics May 21, 2021
    Show notes

    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 Dan Rubin, statistician, Division of Biometrics IV in CDER’s Office of Biostatistics sharing some thoughts draft guidance Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics

    Guidance Recap Podcast | Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products Podcast Dec 15, 2020
    Show notes

    The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors.

    Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance Feb 28, 2020
    Show notes

    Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript

    Guidance Recap Podcast | Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance Feb 28, 2020
    Show notes

    Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript

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