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

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8. Select an FDA Center from the Center drop-down box. The Centers that can be selected atpresent are CBER, CDER, CDRH, CFSAN, CVM, GWTEST, and OOPD. Upon choosing aCenter, the Submission type drop-down box will be populated with the correct submission typesfor that Center.9. Single File Submissions: Click the Browse button associated with the Path textbox to selectthe test submission.10. Multi-File Submissions: Click the Browse button associated with the Root Directorytextbox to select the directory that contains all the files in the test submission. Make sure that thename of any file or sub-directory does not start with "." (dot). Note:the Path field is still requiredfor multi-file submissions. Make sure you have entered a path as well as a root directory.11. Select a test submission type from the Submission type drop-down box. About submissiontypes:- Connectivity tests ensure that your connection to the ESG is up and running. Theyshould be sent to the "Testing" Center.
- Load tests ensure that you are able to send large submissions through the ESG;you should perform a load test if you are planning on sending submissions largerthan 100MB. Load tests should be sent to the "Testing Center." See Section 4.4,Sending Large Submissions.- Guidance-compliant submission tests are reviewed by your Center so they canclear you for a production account. Guidance-compliant submissions should be sentto your Center.12. Select a signing certificate by clicking the associated Browse button and selecting thesigning certificate. All submissions require a certificate to digitally sign and encrypt thesubmission.Note that connectivity tests should only be sent to TESTING, not actual centers.The completed Send document page should be populated similar to the page below.14. Click the Send button on the Send document page.The Enter password dialog box is displayed on top of the Send document page.
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 and 22: 14. Enter a new login User ID and P
Page 23 and 24: Confirm that the correct version of
Page 25: 7. Select the Send document menu it
Page 29 and 30: 20. To access the receipt, click on
Page 31 and 32: 4.4 Apply for a Production System A
Page 33 and 34: submissions (> 7.5 GB), this can ta
Page 35 and 36: When a Center receives a submission
Page 37 and 38: The following information is requir
Page 39 and 40: Be sure to indicate on the applicat
Page 41 and 42: - Create a local environment that s
Page 43 and 44: ___________________________________
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
Page 55 and 56: 2. Select "Windows" from the platfo
Page 57 and 58: 2. Click on the link under Required
Page 59 and 60: 4. With the box unchecked, a warnin
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
Page 67 and 68: Table G-1: Allowable Center Attribu
Page 69 and 70: SAMPLE LETTER #1[Company Letterhead
Page 71 and 72: EDIFACT UNB Header InformationDescr
Page 73 and 74: Consult with an FDA Center represen
Page 75 and 76: Figure 3: File System Settings, Dir
Page 77 and 78:
6. Click on the Save changes button
Page 79 and 80:
Figure 7: Submission Types Supporte
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