The audio of this episode may be broken.
How to fix it?
ABOUT THIS EPISODE
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.
English
United States
SEARCH PAST EPISODES
Search past episodes of FDA CDER Small Business and Industry Assistance (SBIA) Chronicles.
OTHER EPISODES IN THIS PODCAST
The CDER NextGen Portal (or the “Portal” for short) has made it easier than ever for regulated industry to communicate with the FDA.
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds
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 FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities
Disclaimer: The podcast and artwork embedded on this page are from U.S. Food and Drug Administration, Center for Drug Evaluation and Research, which is the property of its owner and not affiliated with or endorsed by Listen Notes, Inc.
EDIT
Thank you for helping to keep the podcast database up to date.