FDA Guidance Recap Podcast
4 FOLLOWERS
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.
FDA Guidance Recap Podcast
2w ago
Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials ..read more
FDA Guidance Recap Podcast
3w ago
Guidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing ..read more
FDA Guidance Recap Podcast
1M ago
Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates ..read more
FDA Guidance Recap Podcast
5M ago
Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development ..read more
FDA Guidance Recap Podcast
5M ago
Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins ..read more
FDA Guidance Recap Podcast
6M ago
Highlights for FDA guidance documents straight from the authors ..read more
FDA Guidance Recap Podcast
7M ago
Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products ..read more
FDA Guidance Recap Podcast
7M ago
Guidance Recap Podcast | Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs—Podcast for Patients ..read more
FDA Guidance Recap Podcast
1y ago
Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers ..read more
FDA Guidance Recap Podcast
1y ago
Guidance Recap Podcast | Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs ..read more