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FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
By U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchScienceMedicineHealth & FitnessGovernmentLife Sciences
FDA CDER Small Business and Industry Assistance (SBIA) Chronicles episodes
- The Role of Pharmacodynamic Biomarkers in Biosimilar Drug DevelopmentThe Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development10 min
- Improving Data Quality with Centralized Statistical Monitoring - with Dr. Paul Schuette and Xiaofeng (Tina) WangListen to Tina Wang, Statistician, and Dr. Paul Schuette, Deputy Division Director, in the Office of Biostatistics Division of Analytics and Informatics within FDA’s Center for Drug Evaluation and Research discuss FDA’s experiences with a centralized statistical monitoring tool.13 min
- Audio Transcript | The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert BallAudio podcast for the pharmaceutical industry on The Need for Artificial Intelligence in Pharmacovigilance and the Emerging Drug Safety Technology Program11 min
- Considerations for Drug Products that Contain NanomaterialsConsiderations for Drug Products that Contain Nanomaterials12 min
- Using Bayesian statistical approaches to advance our ability to evaluate drug productsUsing Bayesian statistical approaches to advance our ability to evaluate drug products8 min
- Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug ProductsInsights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products8 min
- FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived CompoundsFDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds12 min
- The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing FacilitiesThe FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities8 min
- An FDA Self-Audit of Continuous Manufacturing for Drug ProductsContinuous manufacturing (CM) technology has the potential to improve product quality and reliability, lower manufacturing costs, reduce waste, decrease inventory, and increase manufacturing flexibility and agility in response to product demand.12 min
- The Key Elements of Being “Recall-Ready”A voluntary recall is an action taken by a company to correct a violative product or remove it from the market.8 min
About FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
From the publisher's feed
FDA’s Center for Drug Evaluation and Research Small Business and Industry Assistance (SBIA) podcast provides industry with brief synopses of trending regulatory information.