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

More documents

Recommendations

Info

8. Click the Next button.The Locate the certificate file page is displayed.This page is used to specify the location of the certificate file. Each submission must beaccompanied by a certificate. The digital certificate must be an X.509 version 3 certificate.Reference Appendix C., Digital Certificates for more information about digital certificates.
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 20 and 21: 12. Click Next.The Enter user accou
Page 22 and 23: This final page provides an account
Page 24 and 25: 5. Click the WebTrader icon.The Web
Page 26 and 27: 8. Select an FDA Center from the Ce
Page 28 and 29: 16. Enter the certificate password
Page 30 and 31: The receipt for the test submission
Page 32 and 33: The steps to send a Submission to t
Page 34 and 35: An acknowledgement from the Center
Page 36 and 37: 4.8.4 Accessing MDNs and Acknowledg
Page 38 and 39: NOTE: The FDA ESG uses SSL over por
Page 40 and 41: processed by the FDA ESG. FDA stron
Page 42 and 43: Guidance for Industry: ProvidingReg
Page 44 and 45: Solution: When the FDA ESG has rece
Page 46 and 47: To gzip files: gzip Utility at http
Page 48 and 49: organization’s security policy. T
Page 50 and 51: 6. Select the options as shown on t
Page 52 and 53: 3. Select the options as shown belo
Page 54 and 55: Appendix D.Java Runtime Edition Ins
Page 56 and 57: 3. Click the link under Windows Off
Page 58 and 59: 3. Backup your old local_policy.jar
Page 60 and 61: Updating to JRE 1.5.0_15WebTraders
Page 62 and 63: c. Again, using Explorer, delete th
Page 64 and 65: DigitalCertificate(e.g., FDA Center
Page 66 and 67: RAMSSLRandom Access MemorySecure So
Page 68 and 69:
GRAS NoticeNew_Protein_Consultation
Page 70 and 71:
To Whom It May Concern:Pursuant to
Page 72 and 73:
Appendix J. Digital SignaturesFDA d
Page 74 and 75:
As an alternative to using the AS2
Page 76 and 77:
Your list of Available attributes m
Page 78 and 79:
Figure 6: Available Routing shows a
Page 80:
New_Protein_ConsultationThreshold_o
show all

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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?