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ACERCA DE ESTE EPISODIO
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.
Inglés
Estados Unidos
BUSCAR EPISODIOS ANTERIORES
Buscar episodios anteriores de FDA CDER Small Business and Industry Assistance (SBIA) Chronicles.
OTROS EPISODIOS EN ESTE PODCAST
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
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.
The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
The CDER NextGen Portal (or the “Portal” for short) has made it easier than ever for regulated industry to communicate with the FDA.
Descargo de responsabilidad: El podcast y el arte incluidos en esta página son de U.S. Food and Drug Administration, Center for Drug Evaluation and Research, que es propiedad de su propietario y no está afiliado ni respaldado por Listen Notes, Inc.
EDITAR
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