Introduction to the Drug Master File DMF Review Process











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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: https://www.fda.gov/drugs/news-events... • --------------------  • 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 - https://www.fda.gov/cdersbia • SBIA Listserv - https://public.govdelivery.com/accoun... • SBIA 2021 Playlist -    • 2021 CDER Small Business and Industry...   • SBIA LinkedIn:   / cder-small-business-and-industry-assistance   • SBIA Training Resources - https://www.fda.gov/cdersbialearn • Twitter -   / fda_drug_info   • Email - [email protected]   • Phone - (301) 796-6707 I (866) 405-5367

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