FDA covers critical intermediates and how to avoid DMF hidden facilities in order to prevent delays in referencing application approvals.
Presenter:
Wei Liu, Division of Lifecycle API, and Cassandra Abellard, Division of Pharmaceutical Manufacturing in the Office of Pharmaceutical Manufacturing Assessment (OPMA)
Learn more at: [ Ссылка ]
--------------------
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
