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FDA Guidance Recap Podcast

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.

Prenumerera

iTunes / Overcast / RSS

Webbplats

fda.gov/drugs/guidances-drugs/guidance-snapshot-pilot/

Avsnitt

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Thoughts on newly published draft guidance titled, ?Ethical Considerations for Clinical Investigations of Medical Products Involving Children.?
2022-09-23
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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
2022-07-26
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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
2022-06-29
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Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs ? Clinical Pharmacology Considerations

Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs ? Clinical Pharmacology Considerations
2022-06-24
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Guidance Recap Podcast | Bioavailability Studies Submitted in NDAs or INDs ? General Considerations

Guidance Recap Podcast: Bioavailability Studies Submitted in NDAs or INDs ? General Considerations
2022-04-14
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Guidance Recap Podcast | Population Pharmacokinetics

Guidance Recap Podcast: Population Pharmacokinetics
2022-02-04
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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
2021-12-27
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Guidance Recap Podcast | Benefit-Risk Assessment for New Drug and Biologic Products

Guidance Recap Podcast: Benefit-Risk Assessment for New Drug and Biologic Products
2021-09-29
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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
2021-05-21
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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.
2020-12-15
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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
2020-02-28
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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
2020-02-28
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