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U.S. Food and Drug Administration
FDA Guidance Recap Podcast
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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Recent Episodes
Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials
Published 04/22/24
Published 04/22/24
Guidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing
Published 04/16/24
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