FDA Guidance Recap Podcast on Feedspot

FDA Guidance Recap Podcast

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

FDA Guidance Recap Podcast

by U.S. Food and Drug Administration

4d ago

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

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Guidance Recap Podcast | Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs

FDA Guidance Recap Podcast

by U.S. Food and Drug Administration

6d ago

Guidance Recap Podcast | Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs ..read more

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Guidance Recap Podcast | Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs—Podcast for Patients

FDA Guidance Recap Podcast

by U.S. Food and Drug Administration

6d ago

Guidance Recap Podcast | Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs—Podcast for Patients ..read more

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

FDA Guidance Recap Podcast

by U.S. Food and Drug Administration

1w ago

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

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

FDA Guidance Recap Podcast

by U.S. Food and Drug Administration

3M ago

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

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

FDA Guidance Recap Podcast

by U.S. Food and Drug Administration

5M ago

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

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Guidance Recap Podcast | Multiple Endpoints in Clinical Trials

FDA Guidance Recap Podcast

by U.S. Food and Drug Administration

5M ago

Guidance Recap Podcast | Multiple Endpoints in Clinical Trials ..read more

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Guidance Recap Podcast | Ethical Considerations for Clinical Investigations of Medical Products Involving Children

FDA Guidance Recap Podcast

by U.S. Food and Drug Administration

5M ago

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

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

FDA Guidance Recap Podcast

by U.S. Food and Drug Administration

5M ago

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

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

FDA Guidance Recap Podcast

by U.S. Food and Drug Administration

5M ago

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

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