For PADER,
Fill the 356h form for specific section as below:
21. Submission - Periodic Safety Report
22. Submission Sub-Type - Initial Submission
25. Reason for Submission - PADER for mm/dd/yyyy to mm/dd/yyyy
Below link is for your ready reference:
eCTD Important Notices
Once you click the above link, you will find below information:
Submission of periodic safety reports to the eCTD
Periodic safety reports consist of two parts: a descriptive portion and the individual case safety reports (ICSRs). Only the descriptive portion of the periodic safety report can be submitted to the eCTD.
Descriptive portion:
Firms can submit the descriptive portion of the periodic safety report in the following formats: the periodic adverse drug experience report, the periodic adverse experience report or, with an approved waiver, either the periodic safety update report or the periodic benefit-risk evaluation report. The descriptive portion can be submitted to the eCTD in module 5.3.6 and should indicate that the ICSRs have been submitted electronically as XML files to the FDA Electronic Submissions Gateway (ESG).
ICSRs:
Firms can submit ICSRs electronically using ICH E2B(R) standards via the FDA Electronic Submission Gateway (ESG) or via the Safety Reporting Portal (SRP). Submission of ICSRs to the eCTD is not acceptable because these ICSRs cannot be processed into the FDA Adverse Event Reporting System (FAERS) database.
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Gaurang Bhavsar
Edison NJ
United States
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Original Message:
Sent: 15-Mar-2017 02:40
From: Shaista Hussain
Subject: USPR (PADER Submission)
Hello,
Could you please let me know how everyone is publishing the PADER Submission as an amendment or other.