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FDA Safety Report Type Flag Requirement for FAERS Submissions

FDA introduces the FAERS FDA Safety Report Type Flag and how to prepare for this new requirement.

For more information, visit: https://www.fda.gov/drugs/news-events-human-drugs/fda-safety-report-type-flag-requirement-faers-submissions-02192021-02192021

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 – https://www.fda.gov/cdersbia   
SBIA Listserv – https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2021 Playlist – https://youtube.com/playlist?list=PLey4Qe-UxcxYS1MaTusSgyifQDqdeepyD
SBIA LinkedIn – https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance  
SBIA Training Resources – https://www.fda.gov/cderbsbialearn  
Twitter – https://twitter.com/FDA_Drug_Info  
Email – CDERSBIA@fda.hhs.gov  
Phone – (301) 796-6707 I (866) 405-5367

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