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

More documents

Recommendations

Info

Figure 6: Available Routing shows a sample directory and subdirectories that correspondto some of the available routing IDs. A complete list of routing IDs for the FDA ESG arein Figure 7: Submission Types Supported by the FDA ESG.8. Create subdirectories beneath the base integration pickup directory as shown, then dropthe documents that you wish to submit into the appropriate directory. For example, tosend an AERS report, place the document in the "FDA_AERS" directory.9. For multi-document submissions, the original directory structure must be converted to asingle file by using "tar" and then "gzip", and the resulting file must have an extension of.tar.gz for the FDA ESG to correctly recognize it as a multi-document submission. Youmust perform the tar and gzip procedure before dropping the file into the appropriatedirectory, since the Cyclone/Axway software does not know how to tar and gzip on itsown.Note: FDA_AERS and FDA_AERS_ATTACHMENTS submissions cannot be sentas multi-document submissions under any circumstances.
Figure 7: Submission Types Supported by the FDA ESGCenterDestinationCBERSubmission TypesAERSAERS AttachmentsEBLAECTDEIDEEINDeDMFPromotional MaterialRouting IDFDA_AERSFDA_AERS_ATTACHMENTSCBER_EBLACBER_ECTDCBER_EIDECBER_EINDCBER_EDMFCBER_PROMOTIONAL_MATERIALCDERCDRHCFSAN**Lot Distribution DataAERSAERS AttachmentsEANDAEBLAECTDENDAEINDAdverse EventsElectronic SubmissionsFood_Master_FileColor_Master_FileFood_Contact_NotificationCBER_LOT_DISTRIBUTION_DATAFDA_AERSFDA_AERS_ATTACHMENTSCDER_EANDACDER_EBLACDER_ECTDCDER_ENDACDER_EINDCDRH_AERSCDRH_ESUBSCFSAN_FOOD_MASTER_FILECFSAN_COLOR_MASTER_FILECFSAN_FOOD_CONTACT_NOTIFICATION
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 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: 6. Click on the Save changes button
show all

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

Create successful ePaper yourself

Delete template?

Save as template?