Back
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 Jul 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 Jun 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 Mar 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 Sep 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 Jul 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 Jul 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 Apr 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 Apr 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 Mar 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 Dec 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 May 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 May 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 May 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 Sep 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 Jul 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 Apr 2022 | 00:08:02 | |
Guidance Recap Podcast: Bioavailability Studies Submitted in NDAs or INDs – General Considerations | |||
| Guidance Recap Podcast | Population Pharmacokinetics | 04 Feb 2022 | 00:06:24 | |
Guidance Recap Podcast: Population Pharmacokinetics | |||
| Guidance Recap Podcast | Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers | 27 Dec 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 May 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 Dec 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 Feb 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 Feb 2020 | 00:06:54 | |
Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript | |||
© My Podcast Data · Independent project · Data from Apple & Spotify