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FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
16 episodes
9 months ago
FDA’s Center for Drug Evaluation and Research Small Business and Industry Assistance (SBIA) podcast provides industry with brief synopses of trending regulatory information.
Show more...
Medicine
Government,
Health & Fitness,
Science,
Life Sciences
RSS
All content for FDA CDER Small Business and Industry Assistance (SBIA) Chronicles is the property of U.S. Food and Drug Administration, Center for Drug Evaluation and Research and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
FDA’s Center for Drug Evaluation and Research Small Business and Industry Assistance (SBIA) podcast provides industry with brief synopses of trending regulatory information.
Show more...
Medicine
Government,
Health & Fitness,
Science,
Life Sciences
Episodes (16/16)
FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
Improving Data Quality with Centralized Statistical Monitoring - with Dr. Paul Schuette and Xiaofeng (Tina) Wang
11 months ago
12 minutes 30 seconds

FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
Audio Transcript | The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert Ball
11 months ago
11 minutes

FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
Considerations for Drug Products that Contain Nanomaterials
1 year ago
11 minutes 29 seconds

FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
Using Bayesian statistical approaches to advance our ability to evaluate drug products
2 years ago
7 minutes 30 seconds

FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products
2 years ago
7 minutes 59 seconds

FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
2 years ago
9 minutes 48 seconds

FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds
2 years ago
11 minutes 29 seconds

FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities
3 years ago
7 minutes 9 seconds

FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
An FDA Self-Audit of Continuous Manufacturing for Drug Products
3 years ago
11 minutes 13 seconds

FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
The Key Elements of Being “Recall-Ready”
3 years ago
7 minutes 51 seconds

FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
The ABCs of Product Specific Guidances
4 years ago
7 minutes 24 seconds

FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
Improving Regulatory Communication via the CDER NextGen Portal
5 years ago
6 minutes 2 seconds

FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?
6 years ago
7 minutes 49 seconds

FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
Research Investigational New Drug Applications – What You Need To Know
6 years ago
4 minutes 58 seconds

FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
Competitive Generic Therapies
6 years ago
6 minutes 49 seconds

FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
FDA Modernizes Clinical Trials with Master Protocols
6 years ago
5 minutes 35 seconds

FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
FDA’s Center for Drug Evaluation and Research Small Business and Industry Assistance (SBIA) podcast provides industry with brief synopses of trending regulatory information.