FDA Sets Date for Mandatory eCTD Submissions
FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years
The US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically.
http://www.raps.org/Regulatory-Focus/News/2015/05/07/22116/FDA-to-Require-Electronic-Submission-of-New-Drug-Biologic-Files-in-Next-Two-Years/
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf