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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 | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials Apr 22, 2024
    Show notes

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

    Guidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing Apr 16, 2024
    Show notes

    Guidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing

    Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates Mar 26, 2024
    Show notes

    Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates

    Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins Dec 11, 2023
    Show notes

    Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins

    Guidance Recap Podcast | Translation of Good Laboratory Practice Study Reports: Questions and Answers Nov 21, 2023
    Show notes

    Highlights for FDA guidance documents straight from the authors

    Guidance Recap Podcast | Benefit-Risk Assessment for New Drug and Biologic Products Oct 19, 2023
    Show notes

    Guidance Recap Podcast: Benefit-Risk Assessment for New Drug and Biologic Products

    Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products May 25, 2023
    Show notes

    Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products

    Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers May 24, 2023
    Show notes

    Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers

    Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications May 15, 2023
    Show notes

    Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications

    Guidance Recap Podcast | Multiple Endpoints in Clinical Trials Oct 20, 2022
    Show notes

    Guidance Recap Podcast | Multiple Endpoints in Clinical Trials

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