Podcast · News
FDA Guidance Recap Podcast
by U.S. Food and Drug Administration · English · News
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
- New episodes
- Now and then
- Typical length
- 12 min
- Latest
- 7 Jul 2026
- Language
- English
Latest episode
Earlier episodes 26 most recent
-
22 Jun 2026 · 15 min
Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development
-
25 Mar 2026 · 13 min
Guidance Recap Podcast | Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products
-
22 Oct 2025 · 9 min
Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments
Guidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments
-
16 Oct 2024 · 12 min
Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
-
18 Sep 2024 · 18 min
Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
-
24 Jul 2024 · 24 min
Guidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
-
15 Jul 2024 · 15 min
Guidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
-
22 Apr 2024 · 12 min
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
-
16 Apr 2024 · 12 min
Guidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing
-
26 Mar 2024 · 12 min
Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates
-
11 Dec 2023 · 13 min
Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins
-
21 Nov 2023 · 14 min
Guidance Recap Podcast | Translation of Good Laboratory Practice Study Reports: Questions and Answers
Highlights for FDA guidance documents straight from the authors
-
19 Oct 2023 · 13 min
Guidance Recap Podcast | Benefit-Risk Assessment for New Drug and Biologic Products
Guidance Recap Podcast: Benefit-Risk Assessment for New Drug and Biologic Products
-
25 May 2023 · 8 min
Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
-
24 May 2023 · 11 min
Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
-
15 May 2023 · 13 min
Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications
-
20 Oct 2022 · 12 min
Guidance Recap Podcast | Multiple Endpoints in Clinical Trials
-
23 Sep 2022 · 15 min
Guidance Recap Podcast | Ethical Considerations for Clinical Investigations of Medical Products Involving Children
Thoughts on newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”
-
26 Jul 2022 · 9 min
Guidance Recap Podcast | General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products
Guidance Recap Podcast: General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products
-
14 Apr 2022 · 8 min
Guidance Recap Podcast | Bioavailability Studies Submitted in NDAs or INDs – General Considerations
Guidance Recap Podcast: Bioavailability Studies Submitted in NDAs or INDs – General Considerations
-
4 Feb 2022 · 6 min
Guidance Recap Podcast | Population Pharmacokinetics
Guidance Recap Podcast: Population Pharmacokinetics
-
27 Dec 2021 · 12 min
Guidance Recap Podcast | Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers
Recap Podcast: Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers
-
21 May 2021 · 7 min
Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics
Dr. Dan Rubin, statistician, Division of Biometrics IV in CDER’s Office of Biostatistics sharing some thoughts draft guidance Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics
-
15 Dec 2020 · 12 min
Guidance Recap Podcast | Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products Podcast
The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors.
-
28 Feb 2020 · 14 min
Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance
Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript
-
28 Feb 2020 · 7 min
Guidance Recap Podcast | Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance
Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript
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
FDA Guidance Recap Podcast is a English news podcast from U.S. Food and Drug Administration. Melo plays each episode straight from the publisher's own feed — no ads added, no account needed — and remembers where you stopped, in this browser only.
- Publisher
- U.S. Food and Drug Administration
- Language
- English
- Category
- News
- New episodes
- Now and then
- Typical length
- 12 min
- Latest episode
- 7 Jul 2026
- Feed
- RSS — paste into any podcast app
- Apple Podcasts
- podcasts.apple.com/podcast/id1646184051
More English news
Take it with you
The Melo app keeps playing with the screen off, works in the car and on your watch, wakes you to your station, and browses the whole catalogue offline. Free, no ads, no account.
