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FDA Guidance Recap Podcast
By U.S. Food and Drug AdministrationGovernment
FDA Guidance Recap Podcast episodes
- Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology ConsiderationsGuidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations9 min
- Guidance Recap Podcast | Master Protocols for Drug and Biological Product DevelopmentGuidance Recap Podcast | Master Protocols for Drug and Biological Product Development15 min
- Guidance Recap Podcast | Use of Bayesian Methodology in Clinical Trials of Drug and Biological ProductsGuidance Recap Podcast | Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products14 min
- Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes AssessmentsGuidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments9 min
- Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product DevelopmentGuidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development13 min
- Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance StudiesGuidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies19 min
- Guidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical InvestigationsGuidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations25 min
- Guidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide TherapeuticsGuidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics15 min
- Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical TrialsGuidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials13 min
- Guidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on DosingGuidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing13 min
About FDA Guidance Recap Podcast
From the publisher's feed
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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