Director of the Office of New Drug Products (ONDP) Lawrence Yu, Ph.D. in the Office of Pharmaceutical Quality welcomes participants to the Drug Master File (DMF) and Drug Substance Workshop. He provides an overview of past quality issues and current initiatives.
Learn more at: [ Ссылка ]
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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 - [ Ссылка ]
SBIA Listserv - [ Ссылка ]
SBIA 2021 Playlist - [ Ссылка ]
SBIA LinkedIn: [ Ссылка ]
SBIA Training Resources - [ Ссылка ]
Twitter - [ Ссылка ]
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
