| Improving Data Quality with Centralized Statistical Monitoring – with Dr. Paul Schuette and Xiaofeng (Tina) Wang |
December 13, 2024 |
Podcast
(12:30 min, 17.2MB, MP3)
Transcript
|
| The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert Ball |
November 14, 2024 |
Podcast
(11:00 min, 15.1MB, MP3)
Transcript
|
| Considerations for Drug Products that Contain Nanomaterials |
May 17, 2024 |
Podcast
(11:19 min, 16.2MB, MP3)
Transcript
|
| Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products |
August 17, 2023 |
Podcast
(7:30 min, 10.3MB, MP3)
Transcript
|
| Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products |
July 10, 2023 |
Podcast
(7:58 min, 7.31MB, MP3)
Transcript
|
| The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development |
April 10, 2023 |
Podcast
(9:48 min, 13.5MB, MP3)
Transcript
|
| FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds |
February 6, 2023 |
Podcast
(11:28 min, 10.5MB, MP3)
Transcript
|
| The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities |
September 29, 2022 |
Podcast
(7:09 min, 6.54MB, MP3)
Transcript
|
| An FDA Self-Audit of Continuous Manufacturing for Drug Products |
June 28, 2022 |
Podcast
(11:12 min, 10MB, MP3)
Transcript
|
| The Key Elements of Being “Recall-Ready” |
April 19, 2022 |
Podcast
(7:51 min, 7.4MB, MP3)
Transcript
|
| The ABCs of Product Specific Guidances |
September 2, 2021 |
Podcast
(7:23 min, 6.8MB, MP3)
Transcript
|
| Improving Regulatory Communication via the CDER NextGen Portal |
December 19, 2019 |
Podcast
(6:01 min, 6.8MB, MP3)
Transcript
|
| Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA? |
September 19, 2019 |
Podcast
(7:48 min, 9.6MB, MP3)
Transcript
|
| Research Investigational New Drug Applications – What You Need to Know |
June 25, 2019 |
Podcast
(4:58 min, 6.8MB, MP3)
Transcript
|
| Competitive Generic Therapies |
May 23, 2019 |
Podcast
(6:49 min, 9.49MB, MP3)
Transcript
|
| FDA Modernizes Clinical Trials with Master Protocols |
February 26, 2019 |
Podcast
(5:34 min, 5.1MB, MP3)
Transcript
|
Source
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