FDA OC Electronic Gateway
Investment ID: 009-000005326
Overview
Program Title
FDA OC Electronic Gateway
Description
The objective of the FDA Electronic Submissions Gateway is to enable the receipt of guidance-compliant electronic submissions over the Internet and to integrate the processing of these submissions with the business unit environments.
Type of Program
Non-major IT Investments
Multi-Agency Category
Other
Associated Websites
https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm, https://esg.fda.gov/login, https://esgtest.fda.gov/login, https://esgtestreg.preprod.fda.gov/ui/
Investment Detail
FDA ESG is the central transmission point for sending information electronically to the FDA.
Time efficiency is greatly increased and same-day delivery possible.
The number of paper copies generated for submission and archiving is dramatically reduced.
WebTrader transmissions replace media creation with minimal impact and with no additional resources required.
Electronic acknowledgments of successful transmission received and saved.
Shipping expenses are eliminated or greatly reduced.
Support industry and end users including external trading partners through the ESG Help Desk.
Support integration and interfacing efforts by external industry partners and internal FDA partners.
Time efficiency is greatly increased and same-day delivery possible.
The number of paper copies generated for submission and archiving is dramatically reduced.
WebTrader transmissions replace media creation with minimal impact and with no additional resources required.
Electronic acknowledgments of successful transmission received and saved.
Shipping expenses are eliminated or greatly reduced.
Support industry and end users including external trading partners through the ESG Help Desk.
Support integration and interfacing efforts by external industry partners and internal FDA partners.