FDA Online Instruction for eCTD Submissions
The CDER Small Business Assistance Program recently posted a web-based training course on electronic submission in eCTD format. The primary goal and purpose of CDER’s training is to encourage sponsors to submit in eCTD format. The training explains the FDA’s policies and practices regarding electronic submissions and provides sponsors with the fundamental information needed to submit new and transition old applications to the eCTD format.
The training also includes information for sponsors that are currently submitting in paper format and would like to transition existing paper applications to eCTD. The web-based training course takes about an hour to complete and can be accessed here.