1. CDER Combination Product Best Practices
  2. Set up Reporting Destinations

6 Set up Reporting Destinations

To enable reports to be sent for combination products to the FDA, we recommend you configure the reporting destination.

  1. Open the reporting destination that Argus Safety uses to send ICSRs on combination products.
  2. Navigate to the EDI tab and make the following updates:
    For FDA E2B(R2):
    • Select the Message Profile as ICH-ICSR V2.2 MESSAGE TEMPLATE – FDA (standard profile).
    • In the ACK Profile, leave ICH-ICSR V1.1 ACKNOWLEDGMENT TEMPLATE – FDA.
    • Set the URL for Message Schema to https://www.accessdata.fda.gov/xml/icsr-xml-v2.2.dtd.
    • In the URL for Ack Schema, leave http://www.accessdata.fda.gov/xml/icsrack-xml-v1.1.dtd.
    For FDA E2B(R3):
    • Set Agency Identifier as ZZFDA, and Secondary Agency/ Department Identifier as CDER.
    • Select the Message Profile as ICH-ICSR V3.0 MESSAGE TEMPLATE – FAERS (standard profile).
    • Select the ACK Profile as ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE – FAERS.