Drug Applications |
Electronic Common Technical Document (eCTD)FDA would like to work closely with people who plan to provide a submission using the eCTD specifications and offer the following steps to help smooth the process. 1. Review the eCTD specificationsThe following are the specifications for creating the eCTD Backbone Files and Study Tagging Files (eCTD Specifications). The specifications are listed below. Also available is a demonstration of the FDA eCTD Viewer System (EVS) so you can see how the FDA will view eCTD applications. The last link launches an .EXE file that will run the demonstration.
Specifications
2. Contact the FDA before creating a submission
using the eCTD specifications
3. The FDA provides a number for the sample eCTD
submission FDA/Center for Drug Evaluation and Research |