FDA discusses the administrative timeline of a DMF. This includes requesting a pre-assigned DMF number, progression of status form pending to active, subsequent submissions, and advice on administrative aspects of managing a DMF.
Presenter:
Vathsala Selvam, Technical Information Specialist
Division of Lifecycle API
ONDP/OPQ/CDER

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

свернуть