FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
By U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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Category: Medicine
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Subscribers: 3
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Episodes: 12
Description
FDA’s Center for Drug Evaluation and Research Small Business and Industry Assistance (SBIA) podcast provides industry with brief synopses of trending regulatory information.
| Episode | Date |
|---|---|
|
Improving Data Quality with Centralized Statistical Monitoring - with Dr. Paul Schuette and Xiaofeng (Tina) Wang
|
Dec 13, 2024 |
|
Audio Transcript | The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert Ball
|
Nov 15, 2024 |
|
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 |
|
FDA Modernizes Clinical Trials with Master Protocols
|
Feb 26, 2019 |