FDA Guidance Recap Podcast

Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations 07.07.2026 8:51 ↓

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 22.06.2026 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 25.03.2026 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 22.10.2025 8:57 ↓

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 16.10.2024 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 18.09.2024 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 24.07.2024 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 15.07.2024 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 22.04.2024 12:15 ↓

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

Guidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing 16.04.2024 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 26.03.2024 12:02 ↓

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

Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins 11.12.2023 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 21.11.2023 13:39 ↓

Highlights for FDA guidance documents straight from the authors

Guidance Recap Podcast | Benefit-Risk Assessment for New Drug and Biologic Products 19.10.2023 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 25.05.2023 7:34 ↓

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 24.05.2023 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 15.05.2023 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 20.10.2022 11:49 ↓

Guidance Recap Podcast | Multiple Endpoints in Clinical Trials

Guidance Recap Podcast | Ethical Considerations for Clinical Investigations of Medical Products Involving Children 23.09.2022 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 26.07.2022 8:41 ↓

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 14.04.2022 8:02 ↓

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

Guidance Recap Podcast | Population Pharmacokinetics 04.02.2022 6:24 ↓

Guidance Recap Podcast: Population Pharmacokinetics

Guidance Recap Podcast | Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers 27.12.2021 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 21.05.2021 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

Guidance Recap Podcast | Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products Podcast 15.12.2020 11:33 ↓

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