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

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An acknowledgement from the Center to which the submission was sent. This file is named witha unique alphanumeric string known as the Core ID. The Core ID is also used by the FDA ESGto track a submission.A sample Inbox looks similar to this, once submissions have been sent:4.8.3 Message IDs and Core IDsAmong other information, the MDN contains a Message ID and a time stamp denoting the timethe submission was received. The Message ID is a unique alphanumeric string that identifieseach submission. This Message ID can also be used to track a submission and to correlate asubmission to its Center acknowledgement.A sample MDN looks similar to the file shown below. The Message ID and date stamp in thisMDN are highlighted.
When a Center receives a submission, it associates the submission’s Message ID with a Core ID.This Core ID can be used along with the Message ID generated as part of the MDN to track asubmission on the FDA ESG. A sample acknowledgement message with the Core ID highlightedis shown below:
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 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
Page 31 and 32: 4.4 Apply for a Production System A
Page 33: submissions (> 7.5 GB), this can ta
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

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

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