14 episodes
FDA CDER Small Business and Industry Assistance (SBIA) Chronicles U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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- Health & Fitness
FDA’s Center for Drug Evaluation and Research Small Business and Industry Assistance (SBIA) podcast provides industry with brief synopses of trending regulatory information.
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Considerations for Drug Products that Contain Nanomaterials
Considerations for Drug Products that Contain Nanomaterials
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Using Bayesian statistical approaches to advance our ability to evaluate drug products
Using Bayesian statistical approaches to advance our ability to evaluate drug products
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Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products
Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products
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The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
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FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds
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The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities
The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities