FDA Guidance Recap Podcast - U.S. Food and Drug Administration

Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development Oct 16, 2024

Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development

Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies Sep 18, 2024

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

Guidance Recap Podcast | Patient Medication Information (PMI) Proposed Rule Sep 09, 2024

Guidance Recap Podcast | Patient Medication Information (PMI) Proposed Rule

Guidance Recap Podcast | Podcast for Patients on Patient Medication Information (PMI) Proposed Rule Sep 09, 2024

Guidance Recap Podcast | Podcast for Patients on Patient Medication Information (PMI) Proposed Rule

Guidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Jul 15, 2024

Guidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics

Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials Apr 22, 2024

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 | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing Apr 16, 2024

Guidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing

Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates Mar 26, 2024

Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates

Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development Dec 21, 2023

Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development

Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins Dec 11, 2023

Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins

Guidance Recap Podcast | Translation of Good Laboratory Practice Study Reports: Questions and Answers Nov 21, 2023

Highlights for FDA guidance documents straight from the authors

Guidance Recap Podcast | Benefit-Risk Assessment for New Drug and Biologic Products Oct 19, 2023

Guidance Recap Podcast: Benefit-Risk Assessment for New Drug and Biologic Products

Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products May 25, 2023

Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products

Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers May 24, 2023

Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers

Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications May 15, 2023

Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications

Guidance Recap Podcast | Multiple Endpoints in Clinical Trials Oct 20, 2022

Guidance Recap Podcast | Multiple Endpoints in Clinical Trials

Guidance Recap Podcast | Ethical Considerations for Clinical Investigations of Medical Products Involving Children Sep 23, 2022

Thoughts on newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”

Guidance Recap Podcast | General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Jul 26, 2022

Guidance Recap Podcast: General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products

Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments Jun 29, 2022

Guidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments

Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations Jun 24, 2022

Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations

Guidance Recap Podcast | Bioavailability Studies Submitted in NDAs or INDs – General Considerations Apr 14, 2022

Guidance Recap Podcast: Bioavailability Studies Submitted in NDAs or INDs – General Considerations

Guidance Recap Podcast | Population Pharmacokinetics Feb 04, 2022

Guidance Recap Podcast: Population Pharmacokinetics

Guidance Recap Podcast | Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers Dec 27, 2021

Recap Podcast: Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers

Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics May 21, 2021

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

Guidance Recap Podcast | Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products Podcast Dec 15, 2020

The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors.

Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance Feb 28, 2020

Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript

Guidance Recap Podcast | Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance Feb 28, 2020

Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript

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