FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc

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This final page provides an account summary.17. Check box to certify the accuracy of your information..18. Click the Finish button to return to the Login page, or close the browser window.4.2 Test Account Setup and ApprovalAfter successful Test Account setup, the FDA sends an email to the email address provided forthe contact, indicating approval as a Transaction Partner and authorization to send a testsubmission. Typically, the approval notification is sent on the next business day.The test submission cannot be sent until this notification has been received.Java Runtime Edition (JRE) must be installed to send a submission. Reference Appendix D.,Java Runtime Edition Installation for the installation procedures.Once you have fulfilled these criteria, proceed to Section 4.3 for instructions on sending a testsubmission.4.3 Send a Test SubmissionAfter Test Account Setup and Transaction Partner approval, a test submission must be sent toensure that the submission "conduit" is working properly from end to end. To do this, follow thesteps below.
Confirm that the correct version of the JRE is installed before you begin. Reference AppendixD., Java Runtime Edition Installation for the version information and installation procedures.1. Using the address provided by the FDA, access the FDA ESG Web Interface application.The Login page is displayed.Note the test environment warning on the Login page. If the Login page does not have thiswarning, do not send a test submission. Exit the browser and contact the FDA ESGAdministrator at esgprep@fda.hhs.gov to request access to the test environment.3. Enter the User ID and Password that was set up in the registration wizard. Reference Step inSection 4.1, Apply for a Test Account.4. Click the Login button.After a successful login, the My FDA submissions page is displayed. This page lists allmessages received from the FDA ESG.
Page 1 and 2: FDA Electronic Submissions Gateway
Page 3: Appendix C. Digital Certificates...
Page 6 and 7: Figure 1: Overview of the Registrat
Page 8 and 9: 2.6 Send Submissions to the Product
Page 10 and 11: eCTD - Electronic Common Technical
Page 12 and 13: FDAPreparation of multi-filesubmiss
Page 14 and 15: 3.7 Help and InformationThere are r
Page 16 and 17: 4. Click the Next button.The Pick a
Page 18: 8. Click the Next button.The Locate
Page 21: 14. Enter a new login User ID and P
Page 25 and 26: 7. Select the Send document menu it
Page 27 and 28: - Load tests ensure that you are ab
Page 29 and 30: 20. To access the receipt, click on
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Page 33 and 34: submissions (> 7.5 GB), this can ta
Page 35 and 36: When a Center receives a submission
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Page 39 and 40: Be sure to indicate on the applicat
Page 41 and 42: - Create a local environment that s
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Page 45 and 46: Upon receiving the file, signature
Page 47 and 48: or by obtaining a certificate from
Page 49 and 50: 3. Click on the Export button to cr
Page 51 and 52: 9. Give a file name and select the
Page 53 and 54: 4. Create a password for your priva
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Page 61 and 62: . From the Add or Remove Programs d
Page 63 and 64: Appendix E. Glossary of TermsTable
Page 65 and 66: Appendix F. AcronymsA list of acron
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Page 69 and 70: SAMPLE LETTER #1[Company Letterhead
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Consult with an FDA Center represen
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Figure 3: File System Settings, Dir
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6. Click on the Save changes button
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Figure 7: Submission Types Supporte
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