The business of the Food and Drug Administration (FDA) is extremely information intensive. In recognition of this fact and of the potential benefits offered by information technology for information management, the FDA has undertaken a number of projects supporting the electronic submission of text and data from the industries it regulates.
One of these projects entails the establishment of an Agency-wide solution for accepting electronic regulatory submissions, referred to as the FDA Electronic Submissions Gateway (FDA ESG). The FDA ESG enables the submission of regulatory information for review. The overall purpose of the FDA ESG is to provide a centralized, agency-wide communications point for securely receiving electronic regulatory submissions. The new Agency Gateway will enable the FDA to process regulatory information through automated mechanisms while it enables:
The electronic submission process is defined as the receipt, acknowledgment, routing, and notification to a receiving Center of the receipt of an electronic submission. In this definition,
The FDA ESG is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit, or "highway", along which submissions travel to reach their final destination. It does not open or review submissions; it merely routes them to the proper destination.
The FDA ESG uses a software application certified to comply with secure messaging standards. The screen graphics provided in the FDA ESG Web Interface sections of this User Guide are from the application.
The objective of this User Guide is to provide industry participants with information and guidance on how to prepare and send documents through the FDA ESG. See Table 2: Electronic Submissions Supported by the FDA ESG for a list of submissions that the FDA ESG will accept. This document provides a high-level description of the electronic submission process via the FDA ESG.