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Resources FDA E-Submission resources

FDA has a number of informational websites dedicated to helping the drug development community understand how to adopt the new e-submission approach.

An overview of the e-submission process. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/default.htm

Additional guidance documents and resource links.
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm535180.htm

E-learning course on developing and submitting eCTD submissions
https://www.accessdata.fda.gov/cder/eCTD/menu.htm.