FDA’s Electronic Submissions Gateway (ESG)

FDA's Electronic Submissions Gateway (ESG)

April 19, 2016

Presenter: La Misha Fields, Program Manager FDA ESG

Slide 1

Agenda

? What is ESG? ? ESG Process, Account Types ? Account Setup and Differences ? Submission Best Practices ? ESG Program Milestones and Growth ? Help

Slide 2

ESG is:

? A conduit of receiving and delivering regulatory submissions to the appropriate center for further processing.

? The central transmission point for sending information electronically to the FDA and automatically routes them to the proper FDA Center or Office.

? Secure and used Agency-wide.

ESG is NOT:

? A system for tracking the review and approval of a submission. ? It does not open or review the submissions.

Slide 3

ESG Process and Account Types

? Web Interface (WebTrader) - Web Interface sends submissions via Hyper Text Transfer Protocol Secure (HTTPS) through a web browser - Uses Java applet - Uses Tar functionality - WebTrader Hosted solution: a portal to access WebTrader

? Applicability Statement 2 (AS2) Gateway to Gateway - Secure HTTP - Requires files to be tarred - Attribute/Header and routing ID information will be used to route submission - Requires an AS2 compliant gateway software

? All Submissions are signed using PKI certificates

Slide 4

~1-2 Weeks

~1 Day

8. Send Test Submission to Preprod

9. Prod Account Ready to

Use!

Account Setup

1. Request an Account through ESG Help Desk

~1 Day

2. Obtain a Digital

Certificate

~1-2 Weeks

Easy Steps for Setting up Your ESG

Account with the FDA

3. Submit a Non-

repudiation Letter

~2-3 Days

~1 Day

7. Install JRE/JCE and

Configure your Firewall

(WT Only)

~1-2 Days

6. Register Account,

Account Activation

5. Prepare Load Test Submissions

Read User Guide and Tutorials

~1 Day

4. Prepare a Guidance Compliant Test

Submission

~1 Day

Slide 5

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