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Electronic Common Technical Document (eCTD)

14.0K views
Jul 29, 2021
46:23

Jonathan Resnick, project management officer for the Division of Data Management Services and Solutions, discusses the Electronic Common Technical Document (eCTD), recent updates, common errors, frequently asked questions, and information about the Technical Rejection Criteria for Study Data (TRC). Learn More at: https://www.fda.gov/drugs/regulatory-education-industry-redi-annual-conference-2021-07192021-07232021 _______________________________  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 - [email protected] Phone - (301) 796-6707 I (866) 405-5367

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Electronic Common Technical Document (eCTD) | NatokHD