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

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DigitalCertificate(e.g., FDA Center) Transaction Partners.An attachment to an electronic message that allows the recipient toauthenticate the identity of the sender via third party verification froman independent certificate authority. Digital certificates are used toidentify encryption and decryption codes between message sendersand recipients.Non-repudiation A means to provide proof of the integrity and origin of data, both in annon-forgeable relationship that can be verified by any third party atany time, or, an authentication that, with high assurance can beasserted to be genuine.Private KeyPublic KeyTransactionPartnerThe sender of data is provided with proof of delivery and the recipientis assured of the sender's identity, so that neither can later deny havingprocessed the data.In secure communication, an algorithmic pattern used to encryptmessages that only the corresponding public key can decrypt. Theprivate key is also used to decrypt messages that were encrypted bythe corresponding public key. The private key is kept on the user’ssystem and is protected by a password.The private key is normally known only to the key owner. Messagesare encrypted using the public key (see below) and decrypted usingthe private key. For digital signatures, however, a document is signedwith a private key and authenticated with the corresponding publickey.The public key of a public-private key encryption. This key is used toconfirm electronic signatures on incoming messages or to encrypt amessage so that only the holder of the private key can decrypt the fileor message.A public key is held in a digital certificate. Public keys are usuallypublished in a directory. Any public key can encrypt information;however, data encrypted with a specific public key can only bedecrypted by the corresponding private key, which the key ownerkeeps secret.The entity sending submissions/communicating with the receiving androuting component (the FDA ESG) of the community.
Appendix F. AcronymsA list of acronyms relevant to the FDA ESG is provided below:Table F-1: List of AcronymsAcronym PhraseAERS Adverse Event Reporting SystemAS2 Applicability Statement 2CA Certificate AuthorityCBER Center for Biologics Evaluation and ResearchCDER Center for Drug Evaluation and ResearchCDRH Center for Devices and Radiological HealthCFR Code of Federal RegulationsDUNS Data Universal Numbering SystemeANDA Electronic Abbreviated New Drug ApplicationeBLA Electronic Biological License ApplicationseCTD Electronic Common Technical DocumenteDMF Electronic Drug Master FileeIDE Electronic Investigational Device ExemptioneIND Electronic Investigational New Drug ApplicationeNDA Electronic New Drug ApplicationEDR Electronic Document RoomFDA Food and Drug AdministrationFDA ESG FDA Electronic Submissions GatewayHTTP Hyper Text Transfer ProtocolHTTPS Hyper Text Transfer Protocol SecureIND Investigational New DrugJCE Java Cryptography ExtensionJRE Java Runtime EditionMDN Message Delivery NotificationOCIO Office of Chief InformationPDUFA Prescription Drug User Fee ActPKI Public Key Infrastructure
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FDA Electronic Submissions Gateway
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Appendix C. Digital Certificates...
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Figure 1: Overview of the Registrat
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2.6 Send Submissions to the Product
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eCTD - Electronic Common Technical
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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: Appendix E. Glossary of TermsTable
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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