FDA Guidance Recap Podcast: Recent Episodes
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 and background information about a subset of cross-cutting guidance documents on topics that seek to modernize and accelerate drug development.
Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
Guidance Recap Podcast | Podcast for Patients on Patient Medication Information (PMI) Proposed Rule
Guidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
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
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
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
Guidance Recap Podcast | Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs
Guidance Recap Podcast | Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs—Podcast for Patients
Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications
Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
Thoughts on newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”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
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
Guidance Recap Podcast: Bioavailability Studies Submitted in NDAs or INDs – General Considerations
Recap Podcast: Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers
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
The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors.
Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript
Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript