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Introduction to the Drug Master File (DMF) Review Process 

U.S. Food and Drug Administration
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Erin Skoda from the Office of Pharmaceutical Quality, Division of Lifecycle API, discusses the Drug Master File review process from a timeline perspective with an emphasis on key points to be covered during the workshop.
Learn more at: www.fda.gov/drugs/news-events...
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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.  

Upcoming Training - www.fda.gov/cdersbia
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Twitter - / fda_drug_info
Email - CDERSBIA@fda.hhs.gov  
Phone - (301) 796-6707 I (866) 405-5367

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7 авг 2024

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