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

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3. Backup your old local_policy.jar and US_export_policy.jar files before replacing them.You can either rename them (for example, local_policy_old.jar) or put them in a differentdirectory (for example, C:\Program Files\Java\jre1.5.0_15\lib\security\archive).4. Once you have backed up your old files, open the ZIP file that you downloaded. Extractthe new files into C:\Program Files\Java\jre1.5.0_15\lib\security. Make sure that you extractthe new files directly into C:\Program Files\Java\jre1.5.0_15\lib\security and not into asubdirectory.Turning Off Automatic Updates for JavaThe installed JRE will periodically prompt users to download the latest updates. Versions ofJRE other than 1.5.0_15 will not work with WebTrader. The most recent versions of the JRE(JRE 1.4.2_09 and JRE 1.5) will not work with the <strong>FDA</strong> <strong>ESG</strong> web interface and must NOT bedownloaded and installed. Automatic checking for updates can be disabled on the Windowsoperating system as follows:1. Select "Control Panel" from the "Start" menu.2. Double-click on the "Java" icon in the "Control Panel" window to launch the JRE controlpanel.3. Click on the "Update" tab. There will be a checkbox labeled "Check for UpdatesAutomatically". Make sure the checkbox is not checked and then "Apply" the change.
4. With the box unchecked, a warning box will popup: Click the Never Check button tomake sure that the Java Runtime Environment will not automatically be updated. If theJRE is automatically updated, WebTrader will stop working.
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FDA Electronic Submissions Gateway
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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 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: 2. Click on the link under Required
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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FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc

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