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

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eCTD – Electronic Common Technical DocumentIDE – Investigational Device ExemptionIND – Investigational New Drug Application (eCTD and eIND format)DMF – Drug Master FilePromotional MaterialsLot Distribution DataAERS – Adverse Event ReportsAERS AttachmentsANDA – Abbreviated New Drug ApplicationCDERBLA – Biologics License Application (eCTD and eBLA format)eCTD – Electronic Common Technical DocumentNDA – New Drug Application (eCTD and eNDA format)CDRHCVMOCGWTEST*IND – Investigational New Drug ApplicationAdverse EventsElectronic SubmissionsElectronic SubmissionsSLP - Structured Product Labeling (includes NDC Labeler Code Request,Establishment Registration and Drug Listing)CONNECTION TESTSIZE TEST* These submission types are only supported in the Test environment and are intended solely fortesting.3.4 Naming ConventionsA special consideration applies to the naming convention for files and directories. The followingcharacters are not recommended for use when naming submission files and directories:
- forward slash\ - backslash: - colon? - question mark" - quotation marks< - less than sign> - greater than sign| - vertical bar,space - If you need to use a space, use_an_underscore_instead orSeparateWordsWithCapitalLetters.Note: Directories and sub-directories cannot begin with the "." (dot) character.3.5 Determine Submission MethodThere are three options for sending FDA ESG submissions:FDA ESG Web Interface – The FDA ESG Web Interface sends submissions via Hyper TextTransfer Protocol Secure (HTTPS) through a web browser according to Applicability Statement2 (AS2) standards.Applicability Statement 2 (AS2) Gateway-to-Gateway – An electronic submission protocol thatuses HTTP/HTTPS for communications.Determining the best of these options for your organization will be influenced by the types ofsubmissions to be transmitted, infrastructure capabilities, and business requirements.One or more of these options can be selected to submit electronic documents to the FDA.However, a separate registration will be required for each option selected.Considerations for each option are shown in Table 3 below.Table 3: Considerations for Submission Protocol ChoiceAS2FDA ESG Web InterfaceGateway-to-GatewayCost None High setup and support costsSetup Minimal Need to install and configure GatewayUser-friendly webinterfaceYesNoSubmission typessupportedAll, including AERSreportsLong-term support by Yes YesAll, including AERS reports
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 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
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. From the Add or Remove Programs d
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Appendix E. Glossary of TermsTable
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Appendix F. AcronymsA list of acron
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Table G-1: Allowable Center Attribu
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SAMPLE LETTER #1[Company Letterhead
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EDIFACT UNB Header InformationDescr
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Consult with an FDA Center represen
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Figure 3: File System Settings, Dir
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6. Click on the Save changes button
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Figure 7: Submission Types Supporte
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FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc

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