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).

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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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