FDA Guidance Recap Podcast

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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.

U.S. Food and Drug Administration


    • Sep 18, 2024 LATEST EPISODE
    • monthly NEW EPISODES
    • 12m AVG DURATION
    • 28 EPISODES


    Search for episodes from FDA Guidance Recap Podcast with a specific topic:

    Latest episodes from FDA Guidance Recap Podcast

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

    Play Episode Listen Later Sep 18, 2024 18:04


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

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

    Play Episode Listen Later Jul 24, 2024 25:47


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

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

    Play Episode Listen Later Jul 15, 2024 14:56


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

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

    Play Episode Listen Later Apr 22, 2024 12:15


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

    Play Episode Listen Later Apr 16, 2024 12:04


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

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

    Play Episode Listen Later Mar 26, 2024 12:02


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

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

    Play Episode Listen Later Dec 21, 2023 15:13


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

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

    Play Episode Listen Later Dec 11, 2023 13:29


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

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    Guidance Recap Podcast | Translation of Good Laboratory Practice Study Reports: Questions and Answers

    Play Episode Listen Later Nov 21, 2023 13:39


    Highlights for FDA guidance documents straight from the authors

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

    Play Episode Listen Later Oct 19, 2023 12:55


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

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

    Play Episode Listen Later May 25, 2023 7:34


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

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

    Play Episode Listen Later May 24, 2023 11:22


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

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    Guidance Recap Podcast | Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs

    Play Episode Listen Later May 22, 2023 14:14


    Guidance Recap Podcast | Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs

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    Guidance Recap Podcast | Podcast for Patients — Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs

    Play Episode Listen Later May 19, 2023 25:19


    Guidance Recap Podcast | Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs—Podcast for Patients

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

    Play Episode Listen Later May 15, 2023 12:45


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

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

    Play Episode Listen Later Feb 10, 2023 12:17


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

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    Guidance Recap Podcast | Multiple Endpoints in Clinical Trials

    Play Episode Listen Later Oct 20, 2022 11:49


    Guidance Recap Podcast | Multiple Endpoints in Clinical Trials

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    Guidance Recap Podcast | Ethical Considerations for Clinical Investigations of Medical Products Involving Children

    Play Episode Listen Later Sep 23, 2022 14:52


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

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

    Play Episode Listen Later Jul 26, 2022 8:41


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

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

    Play Episode Listen Later Jun 29, 2022 11:29


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

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

    Play Episode Listen Later Jun 24, 2022 8:51


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

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

    Play Episode Listen Later Apr 14, 2022 8:02


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

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    Guidance Recap Podcast | Population Pharmacokinetics

    Play Episode Listen Later Feb 4, 2022 6:24


    Guidance Recap Podcast: Population Pharmacokinetics

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

    Play Episode Listen Later Dec 27, 2021 12:20


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

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

    Play Episode Listen Later May 21, 2021 6:59


    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

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    Guidance Recap Podcast | Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products Podcast

    Play Episode Listen Later Dec 15, 2020 11:33


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

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

    Play Episode Listen Later Feb 28, 2020 14:05


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

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

    Play Episode Listen Later Feb 28, 2020 6:54


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

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