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FDA Guidance Recap Podcast

U.S. Food and Drug Administration
Drug Development
Impaired Renal Function
Antibody Drug Conjugates
FDA Guidance
Clinical Pharmacology
Pharmacokinetics
Chronic Kidney Disease
Drug Clearance
Study Design
E-19 Guideline
Selective Safety Data Collection
Drug-Drug Interactions
Renal Replacement Therapy
Clinical Trials
Dosing Strategies

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.

PublishesTwice monthlyEpisodes30Founded3 years ago
Category
Government

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Artwork for FDA Guidance Recap Podcast

Latest Episodes

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

Guidance Recap Podcast | Patient Medication Information (PMI) Proposed Rule

Guidance Recap Podcast | Podcast for Patients on Patient Medication Information (PMI) Proposed Rule

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Recent Guests

Dr. Mary Tonn-Hai
Deputy Director for Clinical Science in CDER's Office of New Drugs
FDA
Episode: Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials
Dr. Chin Sun
Biologics Lead at the Center for Drug Evaluation and Research, FDA
FDA
Episode: Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates
Dr. Sarah Ridge
Policy Analyst at the Center for Drug Evaluation and Research, FDA
FDA
Episode: Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates

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Apple Podcasts
#120
Taiwan/Government

Talking Points

Recent interactions between the hosts and their guests.

Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials
Q: How does the E-19 guidance ensure the safety of trial participants?
Safety in trials under SSDC is ensured through a thorough understanding of the drug safety profile, ongoing monitoring during trials, and the ability to switch to comprehensive data collection if necessary.
Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials
Q: What is the scope of the E-19 guidance?
FDA's E-19 guidance focuses on the selective collection of safety data in interventional clinical trials, particularly in the post-approval setting, excluding trials for gene therapy or rare diseases.
Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials
Q: What is selective safety data collection and how can it be useful in drug development?
Selective Safety Data Collection (SSDC) is a method that focuses on collecting relevant safety data while ignoring irrelevant information, thereby streamlining clinical trials without compromising participant safety.

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FDA Guidance Recap Podcast launched 3 years ago and published 30 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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Recent guests on FDA Guidance Recap Podcast include:

1. Dr. Mary Tonn-Hai
2. Dr. Chin Sun
3. Dr. Sarah Ridge

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