Common CMC Issues in Type II DMFs and How to Avoid Them

  Рет қаралды 2,949

U.S. Food and Drug Administration

U.S. Food and Drug Administration

Күн бұрын

FDA discusses common quality issues in DMF submissions and briefly discusses resolution strategies and point to consider in order to enhance DMF submissions.
Presenter:
Wei Liu, Division of Lifecycle API
Learn more at: www.fda.gov/dr...
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.  
 
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