關於這一集
Listen 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.
英語
美國
本 Podcast 中的其他單集
Continuous 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.
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds
The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities
The CDER NextGen Portal (or the “Portal” for short) has made it easier than ever for regulated industry to communicate with the FDA.
The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
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