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Rating
5from
This podcast has
27 episodes
Language
EnglishPublisher
U.S. Food and Drug AdministrationExplicit
No
Date created
2022/09/21
Latest episode
2026/07/07
Average duration
14 min.
Release period
82 days
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.
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Check latest episodes from FDA Guidance Recap Podcast podcast
Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
2026/07/07
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
2026/06/22
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
2026/03/25
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
2025/10/22
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
2024/10/16
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
2024/09/18
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
2024/07/24
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
2024/07/15
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
2024/04/22
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
2024/04/16
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
2024/03/26
Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates
Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins
2023/12/11
Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins
Guidance Recap Podcast | Translation of Good Laboratory Practice Study Reports: Questions and Answers
2023/11/21
Highlights for FDA guidance documents straight from the authors
Guidance Recap Podcast | Benefit-Risk Assessment for New Drug and Biologic Products
2023/10/19
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
2023/05/25
Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
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