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FDA Guidance Recap Podcast
U.S. Food and Drug Administration
25 episodes
2 weeks ago
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.
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Government
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All content for FDA Guidance Recap Podcast is the property of U.S. Food and Drug Administration and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
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.
Show more...
Government
Episodes (20/25)
FDA Guidance Recap Podcast
Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments
2 weeks ago
8 minutes 57 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
1 year ago
12 minutes 9 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
1 year ago
18 minutes 4 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
1 year ago
14 minutes 56 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials
1 year ago
12 minutes 15 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing
1 year ago
12 minutes 4 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates
1 year ago
12 minutes 2 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development
1 year ago
15 minutes 13 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins
1 year ago
13 minutes 29 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Translation of Good Laboratory Practice Study Reports: Questions and Answers
1 year ago
13 minutes 39 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Benefit-Risk Assessment for New Drug and Biologic Products
2 years ago
12 minutes 55 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
2 years ago
7 minutes 34 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
2 years ago
11 minutes 22 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications
2 years ago
12 minutes 45 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Multiple Endpoints in Clinical Trials
3 years ago
11 minutes 49 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Ethical Considerations for Clinical Investigations of Medical Products Involving Children
3 years ago
14 minutes 52 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products
3 years ago
8 minutes 41 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
3 years ago
8 minutes 51 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Bioavailability Studies Submitted in NDAs or INDs – General Considerations
3 years ago
8 minutes 2 seconds

FDA Guidance Recap Podcast
Guidance Recap Podcast | Population Pharmacokinetics
3 years ago
6 minutes 24 seconds

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.