FDA Guidance Recap Podcast

About 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.

Publisher

U.S. Food and Drug Administration

Category

government

Language

en

Explicit

No

First episode

28 Feb 2020

Latest episode

25 Mar 2026

Latest episodes

6 of 29 episodes have a transcript.

1. 

   25 Mar 2026

   Guidance Recap Podcast | Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products

   Host Dr. Emily Carter interviews Dr. John Smith, a leading biostatistician, about the FDA's guidance on using Bayesian methodology in drug and biological product clinical trials.

2. 

   18 Sept 2024TRANSCRIPT

   Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies

   Host Dr. John Smith, a clinical pharmacologist, discusses FDA guidance on human radiolabeled mass balance studies, offering insights into regulatory expectations.

3. 

   24 Jul 2024TRANSCRIPT

   Guidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

   Host [Host Name] interviews [Guest Name, Credential] about FDA guidance on digital health technologies for remote data acquisition in clinical investigations.

Inside a recent episode

Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies

Published 18 Sept 2024 · Transcript excerpt

[…] Generally, these studies are a direct way to obtain quantitative, comprehensive, and essential information on absorption, distribution, metabolism, and excretion, also called ADME of the drug in the body. Dr. Dada Panini, can you explain ADME in simple terms? Certainly, it starts with absorption, where the drug moves from where it was administered, like a cream on the skin or a peel that is swallowed into the blastering. Next is distribution, which is all about the drug moving from the blastering to different organs and tissues throughout the body. Then we have metabolism, where the drug is broken down by enzymes into what we call metabolites, which may still be active or not. […]

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41,987,183

Score snapshot 23 Apr 2026

Apple Podcasts (US)

5.0 / 5

10 ratings

Spotify

5.0 / 5

4 ratings

Podcast Authority Score: 5 / 100

A composite of feed quality, social presence, YouTube performance and engagement. Read the methodology.

Quality

0

Social presence

0

YouTube

0

Engagement

27

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