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Explore every episode of the podcast FDA Guidance Recap Podcast
Dive into the complete episode list for FDA Guidance Recap Podcast. Each episode is cataloged with detailed descriptions, making it easy to find and explore specific topics. Keep track of all episodes from your favorite podcast and never miss a moment of insightful content.
| Title | Pub. Date | Duration | |
|---|---|---|---|
| Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations | 07 juil. 2026 | 00:08:51 | |
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 | 22 juin 2026 | 00:14:54 | |
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 | 25 mars 2026 | 00:13:01 | |
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 | 22 oct. 2025 | 00:08:57 | |
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 | 16 oct. 2024 | 00:12:09 | |
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 | 18 sept. 2024 | 00:18:04 | |
Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies | |||
| Guidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations | 24 juil. 2024 | 00:24:04 | |
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 | 15 juil. 2024 | 00:14:56 | |
Guidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics | |||
| Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials | 22 avr. 2024 | 00:12:15 | |
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 | 16 avr. 2024 | 00:12:04 | |
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 | 26 mars 2024 | 00:12:02 | |
Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates | |||
| Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins | 11 déc. 2023 | 00:13:29 | |
Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins | |||
| Guidance Recap Podcast | Translation of Good Laboratory Practice Study Reports: Questions and Answers | 21 nov. 2023 | 00:13:39 | |
Highlights for FDA guidance documents straight from the authors | |||
| Guidance Recap Podcast | Benefit-Risk Assessment for New Drug and Biologic Products | 19 oct. 2023 | 00:12:55 | |
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 | 25 mai 2023 | 00:07:34 | |
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 | 24 mai 2023 | 00:11:22 | |
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 | 15 mai 2023 | 00:12:45 | |
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 | 20 oct. 2022 | 00:11:49 | |
Guidance Recap Podcast | Multiple Endpoints in Clinical Trials | |||
| Guidance Recap Podcast | Ethical Considerations for Clinical Investigations of Medical Products Involving Children | 23 sept. 2022 | 00:14:52 | |
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 | 26 juil. 2022 | 00:08:41 | |
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 | 14 avr. 2022 | 00:08:02 | |
Guidance Recap Podcast: Bioavailability Studies Submitted in NDAs or INDs – General Considerations | |||
| Guidance Recap Podcast | Population Pharmacokinetics | 04 févr. 2022 | 00:06:24 | |
Guidance Recap Podcast: Population Pharmacokinetics | |||
| Guidance Recap Podcast | Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers | 27 déc. 2021 | 00:12:20 | |
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 | 21 mai 2021 | 00:06:59 | |
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 | |||
| Guidance Recap Podcast | Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products Podcast | 15 déc. 2020 | 00:11:33 | |
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 | 28 févr. 2020 | 00:14:05 | |
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 | 28 févr. 2020 | 00:06:54 | |
Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript | |||
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