Electronic Common Technical Document (eCTD) and Study Data (7of15) RedI – May 29-30, 2019

CDER Office of Business Informatics’ Jonathan Resnick and Chao (Ethan) Chen discuss eCTD background, guidance, and metrics; points to consider when preparing to submit electronically; and electronic submission processing. Chen covers technical rejection criteria for study data.

Learn more at https://www.fda.gov/drugs/cder-small-...


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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.

Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities.

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