Electronic Common Technical Document (eCTD)

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-... _______________________________  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/accoun... SBIA 2021 Playlist -    • 2021 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367