Wei Liu, CDER Office of Pharmaceutical Quality, notes Drug Master Files (DMFs) are not “approved” by the FDA, yet they are often vital to application approval. Liu shares common deficiencies from the DMF assessment perspective and points to consider for critical intermediates and DMF facilities.
_______________________________
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 and free continuing education credits: [ Ссылка ]
CDER SBIA 2020 Playlist: [ Ссылка ]
LinkedIn: [ Ссылка ]
Training resources: [ Ссылка ]
Twitter: [ Ссылка ]
CDER small business e-mail update subscription: [ Ссылка ]
Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
![](https://i.ytimg.com/vi/vhvybv0XNMY/maxresdefault.jpg)