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FDA Guidance Recap Podcast U.S. Food and Drug Administration
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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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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 | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials
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Guidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing
Guidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing
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Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates
Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates
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Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development
Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development
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Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins
Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins
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Guidance Recap Podcast | Translation of Good Laboratory Practice Study Reports: Questions and Answers
Highlights for FDA guidance documents straight from the authors