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YouTubeU.S. Food and Drug Administration
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-business ...
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