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Food and Drug AdministrationFDA Electronic Submissions GatewayNew WebTrader Tutorial Document Version Date: 8/1/2017Page 1 of 25Contents 1.0Overview.

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The FDA ESG enables the secure submission of premarket and postmarket 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 the proper FDA Center or Office.

The FDA's eSubmitter software is part of an electronic submissions process that is available for voluntary use by sponsors, manufacturers, and importers to create a variety of submission types within the drug, blood, device, radiological health, tobacco, animal drug and animal food regulated industries.

Register Your WebTrader Account Access the FDA ESG Account Management Portal website at https://esgportal.fda.gov/. Then, select the “New Account Registration” link below the Submit button on the Sign In screen. Follow the step-wise navigation to create a new ESG account.

WebTrader is a Web interface that copies and packages your submission on your desktop in a secure fashion, transmits the submission in a fully encrypted message to the FDA, and then removes any traces of its presence from your PC. For policy questions and to request a WebTrader account, contact esgprep@fda.hhs.gov.

Electronic submissions must include only FDA fillable forms (e.g., 1571, 356h) and electronic signatures to enable automated processing of the submission. The most current FDA forms are available at .fda.gov/AboutFDA/ ReportsManualsForms/Forms. Scanned images of FDA forms will not be accepted.

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 premarket and postmarket regulatory information for review.

FDA's preferred method of submission is via the FDA Electronic Submissions Gateway (ESG).

The FDA's eSubmitter software is part of an electronic submissions process that is available for voluntary use by sponsors, manufacturers, and importers to create a variety of submission types within the drug, blood, device, radiological health, tobacco, animal drug and animal food regulated industries.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232