Background and Project Status
The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of regulatory information for review.
The FDA ESG is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG 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 or Office.
What's New at the Electronic Submissions Gateway
- Letters of Non Repudiation May be Submitted Electronically: Users requesting a new ESG account must send an electronic copy of their Letter of Non Repudiation to ESGHelpDesk@fda.hhs.gov. In addition, users must send a physical copy to the FDA. Users must send a hard copy within 2 weeks or your account may be disabled. For more information on Letters of Non Repudiation and the FDA mailing address, please click here.
Benefit: sending an electronic copy of the Letter of Non Repudiation will make the registration process significantly quicker.
- Single account for CROs or Consultants (or U.S. Agents): CROs or Consultants are no longer required to register for separate accounts for each of your clients. You are now only required to have one ESG account for submissions for all clients. For Steps for CROs, U.S. Agents and Consultants to obtain ESG accounts, please click here.
Benefit: maintaining a single account for all clients will make account management easy for CROs and Consultants.
For ESG Related Questions