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Submit proposed questions on this poster to DMFWorkshop2021@fda.hhs.gov by March 19, 2021, and tune in for the subsequent panel discussion during the Drug Master File (DMF) and Drug Substance follow-up webinar on April 9, 2021.
To review posters and register for the webinar, visit: www.fda.gov/dr...
This poster provides a non-exhaustive list of relevant technical guidance applicable to DMFs and common deficiencies.
To view all posters and conference presentations, visit: www.fda.gov/dr...
To listen to a Q&A on poster and conference topics, visit: www.fda.gov/dr...
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 - www.fda.gov/cd...
SBIA Listserv - public.govdeli...
SBIA 2021 Playlist - • 2021 CDER Small Busine...
SBIA LinkedIn: / cder-small-business-an...
SBIA Training Resources - www.fda.gov/cd...
Twitter - / fda_drug_info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367