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Promotional Submissions in eCTD Format – Grouped Submissions

Jason Cober, Lead Project Manager for the Office of Prescription Drug Promotion, discusses promotional submissions in eCTD format, eCTD structure, contents of grouped submissions, and commons errors with submissions.
Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/promotional-submissions-ectd-format-grouped-submissions-08312021-08312021
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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/cdersbialearn
Twitter – https://twitter.com/FDA_Drug_Info
Email – CDERSBIA@fda.hhs.gov
Phone – (301) 796-6707 I (866) 405-5367

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