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

More documents

Recommendations

Info

Solution: When the FDA ESG has received a complete submission, a backup copy is madebefore the Java applet receives a reply from the server confirming the submission is complete.For large submissions (> 7.5 GB), this can take many minutes. Since there is no network activityfor such a long time, the session timeouts and the Java applet never receives the response. TheFDA ESG has received the submission successfully, but the Java applet returns an error andindicates that the submission needs to be resumed. Receipt of the first acknowledgement (MDN)confirms that the submission was successfully received by the FDA ESG and that it is okay tocancel the resume request. Since this is a large submission, it will take several hours before thefirst acknowledgement is received.FDA has asked Cyclone Commerce to provide an update to the web interface that fixes thiserror.Appendix B. Creating tar Files and Compressing Files for SubmissionCreating tar files for FDA ESG Web Interface SubmissionsDuring the file upload process, the FDA ESG Web Interface utilizes the tar functionality for filesystem consolidation when submitting files. The process occurs during the electronic "signing"of the submission. Before the file is transmitted, it is tarred and gzipped, encrypted, signed, andmime-wrapped (or packaged) before transmitting to the FDA ESG..tar.gz files should not contain files or sub-directories that have a "." (dot) at the beginning of itsname.The figure below illustrates this process.
Upon receiving the file, signature is verified; file is unzipped/untarred, unwrapped/decryptedBecause this process is done automatically during the signing of the file, no intervention isrequired from the user to ensure the file is tarred and gzipped.Creating tar files for Gateway-to-Gateway SubmissionsPartners are required to both tar and gzip (compress) multifile submissions. (gzip is the originalUNIX ZIP format and is used as a compression utility to reduce the size of the archive file.)For best optimization when processing and transmitting large submission files, first "tar" the filesand then compress them using gzip. Valid files acquire a .tar.gz extension resulting from theprocess of tarring the directory (containing multiple files) and gzipping the created tar archive.The figure below illustrates this process.Upon receiving the file, signature is verified; file is unzipped/untarred, unwrapped/decrypted,delivered to Center Holding AreaTo fulfill this requirement, the current AS2 solution should have a tar and zip utility prescribed.There are Operating System-specific utilities available for performing the tar operation.If the application does not have tar/gzip capabilities, a utility must be acquired. Listed below arerecommended utilities that support tar and gzip manually (external from application) orautomatically (to be integrated with application).To create tar files: GNU Tar Utility at http://www.gnu.org/software/tar/tar.html
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 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: ___________________________________
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

Create successful ePaper yourself

Delete template?

Save as template?