You are currently reviewing the Introduction and Overview module.

Additional modules to be covered in the eCTD Overview and Submission training include:

• Background on eCTD Standard. This module provides background on the creation and implementation of the Electronic Common Technical Document (eCTD).
• Submitting in eCTD Format. This module discusses how to submit in eCTD format and utilize the eCTD specifications and guidance.
• Transmitting Electronic Submissions to CDER. This module discusses how to electronically transmit to CDER by Electronic Submissions Gateway (ESG) or via Physical Media.
• Submitting FDA Forms with Submissions. This module discusses which forms are required with submissions.