FDA Guidance Recap Podcast
By U.S. Food and Drug Administration
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Subscribers: 10
Reviews: 0
Episodes: 25
Description
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.
| Episode | Date |
|---|---|
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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
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Apr 22, 2024 |
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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
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Apr 16, 2024 |
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Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates
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Mar 26, 2024 |
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Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development
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Dec 21, 2023 |
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Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins
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Dec 11, 2023 |
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Guidance Recap Podcast | Translation of Good Laboratory Practice Study Reports: Questions and Answers
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Nov 21, 2023 |
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Guidance Recap Podcast | Benefit-Risk Assessment for New Drug and Biologic Products
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Oct 19, 2023 |
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Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
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May 25, 2023 |
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Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
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May 24, 2023 |
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Guidance Recap Podcast | Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs
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May 22, 2023 |
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Guidance Recap Podcast | Podcast for Patients — Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs
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May 19, 2023 |
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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
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May 15, 2023 |
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Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
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Feb 10, 2023 |
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Guidance Recap Podcast | Multiple Endpoints in Clinical Trials
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Oct 20, 2022 |
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Guidance Recap Podcast | Ethical Considerations for Clinical Investigations of Medical Products Involving Children
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Sep 23, 2022 |
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Guidance Recap Podcast | General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products
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Jul 26, 2022 |
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Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments
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Jun 29, 2022 |
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Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
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Jun 24, 2022 |
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Guidance Recap Podcast | Bioavailability Studies Submitted in NDAs or INDs – General Considerations
|
Apr 14, 2022 |
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Guidance Recap Podcast | Population Pharmacokinetics
|
Feb 04, 2022 |
|
Guidance Recap Podcast | Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers
|
Dec 27, 2021 |
|
Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics
|
May 21, 2021 |
|
Guidance Recap Podcast | Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products Podcast
|
Dec 15, 2020 |
|
Guidance Recap Podcast | Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance
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Feb 28, 2020 |
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Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance
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Feb 28, 2020 |