FDA Guidance Recap Podcast

By U.S. Food and Drug Administration

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 ... more

· Government

5

88 ratings

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FAQs about FDA Guidance Recap Podcast:

How many episodes does FDA Guidance Recap Podcast have?

The podcast currently has 29 episodes available.

FDA Guidance Recap Podcast episodes:

September 23, 2022 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Thoughts on newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”
...more
15min
July 26, 2022 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
...more
9min
April 14, 2022 Guidance Recap Podcast | Bioavailability Studies Submitted in NDAs or INDs – General Considerations
Guidance Recap Podcast: Bioavailability Studies Submitted in NDAs or INDs – General Considerations
...more
9min
February 04, 2022 Guidance Recap Podcast | Population Pharmacokinetics
Guidance Recap Podcast: Population Pharmacokinetics
...more
7min
December 27, 2021 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
...more
13min
May 21, 2021 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 Dan Rubin, statistician, Division of Biometrics IV in CDER’s Office of Biostatistics sharing some thoughts draft guidance Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics
...more
7min
December 15, 2020 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.
...more
12min
February 28, 2020 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
...more
15min
February 28, 2020 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
...more
7min

FAQs about FDA Guidance Recap Podcast:

How many episodes does FDA Guidance Recap Podcast have?

The podcast currently has 29 episodes available.

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