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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 ... more
FAQs about FDA Guidance Recap Podcast:How many episodes does FDA Guidance Recap Podcast have?The podcast currently has 28 episodes available.
June 24, 2022Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology ConsiderationsGuidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations...more9minPlay
April 14, 2022Guidance Recap Podcast | Bioavailability Studies Submitted in NDAs or INDs – General ConsiderationsGuidance Recap Podcast: Bioavailability Studies Submitted in NDAs or INDs – General Considerations...more9minPlay
February 04, 2022Guidance Recap Podcast | Population PharmacokineticsGuidance Recap Podcast: Population Pharmacokinetics...more7minPlay
December 27, 2021Guidance Recap Podcast | Pathology Peer Review in Nonclinical Toxicology Studies: Questions and AnswersRecap Podcast: Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers...more13minPlay
May 21, 2021Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and BiologicsDr. Dan Rubin, statistician, Division of Biometrics IV in CDER’s Office of Biostatistics sharing some thoughts draft guidance Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics...more7minPlay
December 15, 2020Guidance Recap Podcast | Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products PodcastThe Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors....more12minPlay
February 28, 2020Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final GuidanceGuidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript...more15minPlay
February 28, 2020Guidance Recap Podcast | Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final GuidanceClinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript...more7minPlay
FAQs about FDA Guidance Recap Podcast:How many episodes does FDA Guidance Recap Podcast have?The podcast currently has 28 episodes available.