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 www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/regulatory-education-industry-redi-annual-conference-may-29-30-2019
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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.
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