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Episode | Date |
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Considerations for Drug Products that Contain Nanomaterials
|
May 15, 2024 |
Using Bayesian statistical approaches to advance our ability to evaluate drug products
|
Aug 18, 2023 |
Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products
|
Jul 11, 2023 |
The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
|
Apr 10, 2023 |
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds
|
Feb 07, 2023 |
The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities
|
Sep 29, 2022 |
An FDA Self-Audit of Continuous Manufacturing for Drug Products
|
Jun 28, 2022 |
The Key Elements of Being “Recall-Ready”
|
Apr 20, 2022 |
The ABCs of Product Specific Guidances
|
Sep 03, 2021 |
Improving Regulatory Communication via the CDER NextGen Portal
|
Dec 19, 2019 |
Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?
|
Sep 19, 2019 |
Research Investigational New Drug Applications – What You Need To Know
|
Jun 25, 2019 |
Competitive Generic Therapies
|
May 23, 2019 |
FDA Modernizes Clinical Trials with Master Protocols
|
Feb 26, 2019 |