Kun Shen from the Office of Generic Drugs discusses the patent listing process including a walkthrough of Forms 3542/3542a and how the forms are processed. Shen also covers changes to Form 3542 instructions and how to avoid frequent mistakes.
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 2020 Playlist - [ Ссылка ]
SBIA LinkedIn - [ Ссылка ]
SBIA Training Resources - [ Ссылка ]
Twitter - [ Ссылка ]
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
