The FDA Electronic Submissions Gateway is an Agency-wide solution for accepting electronic regulatory submissions and is the preferred method of transmission for eCTDs.

The FDA ESG enables the secure submission of regulatory information and is a conduit along which submissions travel to reach their final destination. It does not open or review submissions; it automatically routes them to the proper FDA Center.

You can transmit your eCTD INDs, NDAs, ANDAs, DMFs and BLAs via the ESG.

Use of a fillable form is preferred, and can facilitate your submissions being in reviewers' hands in as little as 15 minutes!